|
subjectkey |
GUID |
|
Required |
The NDAR Global Unique Identifier (GUID) for research subject |
NDAR*
|
|
guid |
|
src_subject_id |
String |
20
|
Required |
Subject ID how it's defined in lab/project |
|
|
SUBJECT, bid, demo_study_id, patid, pid, randid, record_id, subject_id, subjectid |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
IECDate, chrcrit_date, date_consent, elg_ct_doa, elg_p_doa, iedt, intvdate, visit_date |
|
interview_age |
Integer |
|
Required |
Age in months at the time of the interview/test/sampling/imaging. |
0::1440
|
Age is rounded to chronological month. If the research participant is 15-days-old at time of interview, the appropriate value would be 0 months. If the participant is 16-days-old, the value would be 1 month.
|
age, intvage |
|
sex |
String |
20
|
Required |
Sex of subject at birth |
M;F; O; NR
|
M = Male; F = Female; O=Other; NR = Not reported
|
gender, iec13a, rdm13, sex |
Query
|
aescode |
Integer |
|
Recommended |
Staff code number of person completing this form |
|
999= Missing Data
|
IECCODE |
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
inex_interval, interval, timept, visit_name, vtypscrn |
Query
|
iec1 |
Integer |
|
Recommended |
Has the patient demonstrated adequate decisional capacity to make a choice about participating in this research study AND provided informed consent to participate? |
|
0=No; 1= Yes
|
elg_ct_can_consent, elg_p_can_consent, ieca1b, ieca3_1, incic, rdm1 |
Query
|
iec2 |
Integer |
|
Recommended |
Is the patient older than 18 years of age? |
0;1
|
0=No; 1= Yes
|
agege18, ieca3 |
Query
|
iec3 |
Integer |
|
Recommended |
Does the patient have a diagnosis of schizophrenia or schizoaffective disorder (DSM-IV-TR), confirmed by SCID? |
0;1
|
0=No; 1= Yes
|
ieca2, ieca4_1, rdm3 |
Query
|
iec4 |
Integer |
|
Recommended |
Are the patient's PANSS scores for Hallucinatory Behavior (Item P3), Unusual Thought Content (Item G9) and Conceptual Disorganization (Item P2) each ? 5? |
0;1
|
0=No; 1= Yes
|
|
Query
|
iec5 |
Integer |
|
Recommended |
In the judgment of the Investigator, will the patient be able to complete the baseline MATRICS Consensus Cognitive Battery (MCCB) validly? |
0;1
|
0=No; 1= Yes
|
|
Query
|
iec6 |
Integer |
|
Recommended |
Does the patient have a raw score >=37 on the WRAT-3? |
0;1
|
0=No; 1= Yes
|
|
Query
|
iec7 |
Integer |
|
Recommended |
Did the patient learn English before age 12? |
0;1
|
0=No; 1= Yes
|
|
Query
|
iec8 |
Integer |
|
Recommended |
Is the patient able to state specific goals relevant to the intervention that they would like to achieve? |
0;1
|
0=No; 1= Yes
|
|
Query
|
iec9 |
Integer |
|
Recommended |
In the judgment of the Investigator, will the patient be able to participate in the computerized intervention? |
0;1
|
0=No; 1= Yes
|
|
Query
|
iec10 |
Integer |
|
Recommended |
Has the patient had a psychiatric hospitalization in the 8 weeks prior to randomization? |
0;1
|
0=No; 1= Yes
|
|
Query
|
iec11 |
Integer |
|
Recommended |
Has the patient had an adjustment to their antipsychotic medication in the 4 weeks prior to randomization? |
0;1
|
0=No; 1= Yes
|
|
Query
|
iec12 |
Integer |
|
Recommended |
Is the patient currently taking an anticholinergic medication? |
0;1
|
0=No; 1= Yes
|
|
Query
|
iec13 |
Integer |
|
Recommended |
Does the patient have a diagnosis of alcohol or substance abuse (other than nicotine) within the past month, confirmed by SCID? |
0;1
|
0=No; 1= Yes
|
dsm, ieca18 |
Query
|
iec14 |
Integer |
|
Recommended |
Does the patient have a diagnosis of alcohol or substance dependence (other than nicotine) within the past 6 months, confirmed by SCID? |
0;1
|
0=No; 1= Yes
|
|
Query
|
iec15 |
Integer |
|
Recommended |
Does the patient have a history of mental retardation, pervasive developmental disorder, or other neurological disorder (such as Traumatic Brain Injury, epilepsy, or Parkinsons disease)? |
0;1
|
0=No; 1= Yes
|
db_exc6, ieca12 |
Query
|
iec16 |
Integer |
|
Recommended |
Eligibility status |
1::3
|
1=Eligible; 2= Ineligible; 3=Pending
|
iea003a, ieca13, ieca25 |
Query
|
iecsig |
Integer |
|
Recommended |
Investigator signature on form. |
0;1
|
0=No; 1= Yes
|
|
Query
|
daysrz |
Integer |
|
Recommended |
days since randomization |
|
|
iec0b, rdm0b, studyday |
Query
|
certcode |
Integer |
|
Recommended |
stepbd certification code |
|
|
|
Query
|
ptcon |
Integer |
|
Recommended |
Patient consented |
|
0=No; 1=Yes
|
consent1, db_inc8 |
Query
|
dsmcrit |
Integer |
|
Recommended |
Meets criteria for Bipolar Disorder, Type I or II |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
conceive |
Integer |
|
Recommended |
Patient must be of childbearing potential and wanting to conceive |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
agrtobc |
Integer |
|
Recommended |
Patient agrees to use adequate birth control until week 14 of the study or as otherwise advised by the treating psychiatrist |
0::2;-7
|
0=No; 1=Yes; -7=Refused; 2=NA
|
ieca10_1 |
Query
|
cmfrecov |
Integer |
|
Recommended |
CMF recovered status |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
cmfstat |
Integer |
|
Recommended |
CMF recovery time |
1;2;-7
|
1=Recovered > 1 year; 2=Recovered<=1 year; -7=Refused
|
|
Query
|
subabuse |
Integer |
|
Recommended |
curr substance abuse or depend |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
unmedill |
Integer |
|
Recommended |
Unstable medical illness |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
elg_ct_acute_illness, elg_p_acute_illness, excs16, inex_exc1 |
Query
|
othstudy |
Integer |
|
Recommended |
Patient participating in Non-STEP-BD study |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pregnant |
Integer |
|
Recommended |
Patient is currently pregnant |
0::2;-7; 999
|
0=No; 1=Yes;2=DK;-7= Refused; 999=Legimately skipped
|
elg_ct_pregnancy, elg_p_pregnancy, iea002o, iec14a, ieca11, inex_exc8, preg, rdm14, rdm14a |
Query
|
psychsym |
Integer |
|
Recommended |
Psychotic symptoms |
0;1;-7; -9
|
0=No; 1=Yes; -7=Refused; -9 =unknown
|
|
Query
|
psychmed |
Integer |
|
Recommended |
Patientt is taking > 5 psychotropic meds |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
takenom3 |
Integer |
|
Recommended |
Patient has taken Omega-3 fatty acids (fish oil, flax seed oil, etc.) in the past 4 weeks |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
rzrcpprg |
Integer |
|
Recommended |
Did you ask the patient if she would like to be randomized to the Pregnancy RCP? |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
ccpp |
Integer |
|
Recommended |
Did the patient agree to participate in Collaborative Care-Plus (CCP-P)? |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
ccppday |
Integer |
|
Recommended |
CCP-P consent days from randomization |
|
|
|
Query
|
othrpart |
Integer |
|
Recommended |
Does the patient have a family member, a spouse, or close friend who would be willing to take part in treatment? |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
inex_site_x, site_ga, site_id, site_uid, siteid |
Query
|
vital_collect |
Integer |
|
Recommended |
Was any data collected for this form? |
|
1 = Yes; 0 = No
|
|
Query
|
incexq1 |
Integer |
|
Recommended |
Inclusion Criteria: Diagnosis of ASD as defined by DSM-5, confirmed by clinical evaluation and supported by the Autism Diagnostic Observation Schedule (ADOS) |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
iea001a |
Query
|
incexq2 |
Integer |
|
Recommended |
Inclusion Criteria: Age 18-35 years inclusive |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
iea001b, iec2a, ieh001a, rdm2 |
Query
|
incexq3 |
Integer |
|
Recommended |
Inclusion Criteria: IQ estimate of greater than or equal to 80 |
0;1;-9;-7
|
0=No; 1=Yes; -9=unknown; -9=unknown; -7=refused
|
iea001c, ieh001b |
Query
|
incexq4 |
Integer |
|
Recommended |
Inclusion Criteria: Clinical Global Impression - Severity scale of 4 (moderate) or greater |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
iea001d |
Query
|
incexq5 |
Integer |
|
Recommended |
Inclusion Criteria: Existing allowed concomitant medication treatment stable for the 8 weeks prior to study entry, and no anticipated changes |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
iea001e |
Query
|
incexq6 |
Integer |
|
Recommended |
Inclusion Criteria: Capacity to provide informed consent as demonstrated by a score of greater than 14.5 on the UBACC |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
iea001f |
Query
|
incexq7 |
Integer |
|
Recommended |
Inclusion Criteria: Ability to comply with all protocol procedures and assessments |
|
0=No; 1=Yes; -9=unknown
|
iea001g, ieh001c, incproc |
Query
|
incexq8 |
Integer |
|
Recommended |
Inclusion Criteria: Availability of an informant willing to provide information regarding subject behavior and health status |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
iea001h |
Query
|
incexq9 |
Integer |
|
Recommended |
Inclusion Criteria: Evidence of EEG biomarker deficit as defined in section C4.3 |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
iea001i |
Query
|
incexq10 |
Integer |
|
Recommended |
Exclusion Criteria: Evidence of current drug or alcohol abuse or dependence |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
iea002a |
Query
|
incexq11 |
Integer |
|
Recommended |
Exclusion Criteria: History of current or prior drug or alcohol use or dependence in past 12 months |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
iea002b, ieh002a |
Query
|
incexq12 |
Integer |
|
Recommended |
Exclusion Criteria: History of seizure disorder (except febrile seizures) |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
iea002c, ieh002b, q13_6a |
Query
|
incexq13 |
Integer |
|
Recommended |
Exclusion Criteria: Clinically significant aggressive, disruptive, or suicidal behavior in the 3 months prior to study enrollment |
|
0=No; 1=Yes; -9=unknown
|
exsuicid, iea002d |
Query
|
incexq14 |
Integer |
|
Recommended |
Exclusion Criteria: Clinical evidence of lifetime history of psychotic disorder, bipolar disorder, or other serious psychopathology which in the judgment of the study physician would impair the individuals ability to comply with the protocol or potentially increase risk of adverse events |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
iea002e |
Query
|
incexq15 |
Integer |
|
Recommended |
Exclusion Criteria: Presence of a chronic medical condition or prohibited medication (see list in Human Subjects section) which would potentially interfere with the assessment of treatment effects, or interact with study medications (eg. hepatic, neurologic, renal disease) to increase risk to the subject. |
0;1;-7;-9
|
0=No; 1=Yes; -9=unknown; -7=refused
|
iea002f, ieh002e |
Query
|
incexq16 |
Integer |
|
Recommended |
Exclusion Criteria: History of narrow-angle glaucoma |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
iea002g |
Query
|
incexq17 |
Integer |
|
Recommended |
Exclusion Criteria: History of paradoxical reactions to benzodiazepines |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
iea002h |
Query
|
incexq18 |
Integer |
|
Recommended |
Exclusion Criteria: Clinically significant deviation from the reference range in clinical laboratory test results at screening, as judged by the investigator |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
iea002i, ieh002f |
Query
|
incexq19 |
Integer |
|
Recommended |
Exclusion Criteria: ALT or AST greater than the upper limit of the laboratory standard reference range at screening. |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
iea002j |
Query
|
incexq20 |
Integer |
|
Recommended |
Exclusion Criteria: EKG abnormalities considered to be clinically significant as determined by the investigator and confirmed by an experienced cardiologist |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
iea002k |
Query
|
incexq21 |
Integer |
|
Recommended |
Exclusion Criteria: Fredericia-corrected QT (QTcF) interval of >450 msec |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
iea002l |
Query
|
incexq22 |
Integer |
|
Recommended |
Exclusion Criteria: Clinical judgment of the study physician of inability to perform the requirements of the study |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
iea002m |
Query
|
incexq23 |
Integer |
|
Recommended |
Exclusion Criteria: For sexually active female and male subjects, refusal to agree to maintain a double-barrier birth control method during protocol participation |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
iea002n |
|
incexq24 |
Date |
|
Recommended |
If yes, date of eligibility |
|
|
eligible_date, iea003b, iec003b, ieh003b |
Query
|
incexq25 |
Integer |
|
Recommended |
If no, specify ineligibility |
1::8; -9
|
1=Failed to meet inclusion or met exclusion criteria; 2=Declined study participation/withdrew consent; 3=Failed to return to clinic; 4=Moved from area; 5=Incarceration; 6=Death; 7=Other, specify; 8=Rater did not approve enrollment after interview; -8=unknown
|
iea003c, iec003c, ieh003c, scrflrs |
|
comments_misc |
String |
4,000
|
Recommended |
Miscellaneous comments on study, interview, methodology relevant to this form data |
|
|
elg_ct_notes, elg_p_notes |
Query
|
visitid |
Integer |
|
Recommended |
MetaTrial Visit ID |
|
System variable: unique code for each type of visit -use to merge files
|
|
Query
|
fseqno |
Integer |
|
Recommended |
Sequence Number |
0::999
|
The FSEQNO variable in the ADJ form has a special interpretation compared to other forms.
For example, ADJ FSEQNO of '1' can be thought of as being '001', FSEQNO of '2' can be thought of as
being '002', and FSEQNO of '3' can be thought of as being '003'.
The first digit of FSEQNO relates to the corresponding ENF sequence number at that visit and the third
digit relates to the specific adjudicator who completed the adjudication form.
|
|
Query
|
visday |
Integer |
|
Recommended |
Number of days from study baseline to date of visit |
|
|
dayraf, ieca0b, inex_visitdat_x |
Query
|
ieca1a |
Integer |
|
Recommended |
UBACC Score |
0::20
|
|
|
Query
|
ieca4 |
Integer |
|
Recommended |
Does the treating clinician feel the patient is likely to benefit from treatment with study medication? |
0;1
|
1=yes; 0=no
|
|
Query
|
ieca5 |
Integer |
|
Recommended |
Is the patient at risk of efficacy failure based on history of efficacy failure or other exacerbation (refer to page 2 of IEC form) in the setting of known or suspected medication non-compliance with oral medication or significant substance abuse |
0;1
|
1=yes; 0=no
|
|
Query
|
ieca6 |
Integer |
|
Recommended |
If child bearing potential, was serum pregnancy test negative? (code X if not applicable) |
0;1
|
1=yes; 0=no
|
|
Query
|
ieca7 |
Integer |
|
Recommended |
Is patient currently stable and doing well on antipsychotic regimen? |
0;1
|
1=yes; 0=no
|
iec4a, ieca6a, rdm4 |
Query
|
ieca8 |
Integer |
|
Recommended |
Is patient not expected to benefit from study medication due to past experience with risperidone, paliperidone or haloperidol (refer to page 2 of IEC form)?. |
0;1
|
1=yes; 0=no
|
|
Query
|
scrn10 |
Integer |
|
Recommended |
10. Does the patient have tardive dyskinesia |
0::4
|
0=No; 1=Yes;2=Current; 3=In partial remission; 4=Past
|
ieca9 |
Query
|
ieca10 |
Integer |
|
Recommended |
Does the patient have any medical condition that in the judgment of the investigator might preclude safe completion of the study (e.g., agranulocytosis, unstable heart disease, AIDS, end-stage renal disease)? |
|
1=yes; 0=no
|
db_exc7, exother, iec20, ieca24, rdm20 |
Query
|
version_form |
String |
121
|
Recommended |
Form used/assessment name |
|
|
form_name, vers |
Query
|
rdm24 |
Integer |
|
Recommended |
Do you want to randomize this patient |
0;1
|
0=No; 1=Yes
|
|
Query
|
site_p |
String |
5
|
Recommended |
Pseudo Site: Pooled According To Size |
|
|
|
Query
|
consent |
Integer |
|
Recommended |
Consent at screening |
0;1
|
0=No; 1=Yes;
|
|
Query
|
sel |
Integer |
|
Recommended |
Eligible at screening |
0;1
|
0=No; 1=Yes;
|
|
Query
|
selun |
Integer |
|
Recommended |
Screen Eligibility Unknown |
0;1
|
0=No; 1=Yes;
|
|
Query
|
snel |
Integer |
|
Recommended |
Ineligible at screening |
0;1
|
0=No; 1=Yes;
|
|
Query
|
scr |
Integer |
|
Recommended |
Screened |
0;1
|
0=No; 1=Yes;
|
|
Query
|
iec16b |
Integer |
|
Recommended |
Is she using an adequate method of contraception to avoid pregnancy? (Y/N) (Acceptable methods include oral, injectable or implanted contraceptives, intrauterine devices, or barrier methods such as condoms, diaphragm, and spermicides) (YES is eligible) |
|
0=No; 1=Yes; 999=Legitimately skipped
|
incbirth, rdm16a |
Query
|
bmi |
Float |
|
Recommended |
body mass index of subject |
|
-9 = Missing
|
iec5a, rdm5 |
|
laba125 |
String |
20
|
Recommended |
Nhdl |
|
|
iec10a, iec6a1, rdm10, rdm6 |
Query
|
laba6 |
Integer |
|
Recommended |
LDL Cholesterol (mg/dL) |
|
-9=Unknown; -1=Normal
|
iec6a, rdm6a |
Query
|
laba3a |
Integer |
|
Recommended |
Fasting Glucose (Mg/Dl) |
|
|
iec7a, rdm7 |
Query
|
mdga10c |
Integer |
|
Recommended |
Is patient now on oral hypoglycemic agent |
0;1
|
1=Yes; 0=No
|
iec8a, rdm8 |
Query
|
iec9a |
Integer |
|
Recommended |
Is the patient being treated with insulin? (Y/N) (NO is eligible) |
0;1
|
0=No; 1=Yes
|
rdm9 |
Query
|
rsptrig_no |
Float |
|
Recommended |
Blood value - Triglycerides (mg/dL) |
|
-9=Unknown
|
iec11a, rdm11 |
Query
|
iec12a |
Integer |
|
Recommended |
Is the patient in their first episode of schizophrenia or schizoaffective disorder? (Y/N) (Patients will be considered
to be in their first episode if the patient first began antipsychotic drug treatment for psychosis within the previous 6 months.) (NO is eligible) |
0;1
|
0=No; 1=Yes
|
rdm12 |
Query
|
breastfd |
Integer |
|
Recommended |
currently breast feeding |
0;1;-7; 999
|
0=No; 1=Yes;-7= Refused; 999=Legimately skipped
|
iec15a, rdm15a |
Query
|
iec16a |
Integer |
|
Recommended |
Is she a woman who can become pregnant? (Y/N) (NO is eligible) Note: Yes may be eligible if answer to Q16a is YES |
0;1;999
|
0=No; 1=Yes; 999=Legitimately skipped
|
rdm16 |
Query
|
iec17 |
Integer |
|
Recommended |
Is the patient, in the judgment of the investigator, at a high risk for suicide? (Y/N) |
0;1
|
0=No; 1=Yes
|
rdm17 |
Query
|
iec18 |
Integer |
|
Recommended |
Does the patient have a history of cerebrovascular or cardiovascular disease (i.e., stroke, transient ischemic
attacks (TIAs), coronary artery disease, angina, heart attack/myocardial infarction, peripheral vascular disease, abdominal aortic aneurysm, or congestive heart failure)? (NO to MHXA1a to MHXA1h is eligible) |
0;1
|
0=No; 1=Yes
|
rdm18 |
Query
|
iec19 |
Integer |
|
Recommended |
Does the patient have a history of HIV/AIDS? (NO to MHXA3 is eligible) |
0;1
|
0=No; 1=Yes
|
rdm19 |
Query
|
iec21 |
Integer |
|
Recommended |
Does the patient have a DSM-IV TR diagnosis of mental retardation, pervasive developmental disorder, delirium, dementia, amnesia, or other cognitive disorder? (Y/N) (NO is eligible) |
0;1
|
0=No; 1=Yes
|
ieca16, rdm21 |
Query
|
iec22 |
Integer |
|
Recommended |
Has the patient participated in a clinical trial with an investigational agent within the four weeks preceding baseline? (Y/N) (NO is eligible) |
0;1
|
0=No; 1=Yes
|
rdm22 |
Query
|
iec23 |
Integer |
|
Recommended |
Have you collected all of the screening information necessary to determine eligibility for this patient? |
0;1
|
0=No; 1=Yes
|
rdm23 |
Query
|
race |
String |
30
|
Recommended |
Race of study subject |
American Indian/Alaska Native; Asian; Hawaiian or Pacific Islander; Black or African American; White; More than one race; Unknown or not reported; Other Non-White; Other
|
|
race1 |
|
session_id |
String |
20
|
Recommended |
session ID/screening ID |
|
|
screeningid |
Query
|
exc_1 |
Integer |
|
Recommended |
Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study |
1::3
|
1=Yes; 2=No; 3=N/A
|
|
Query
|
exc_2 |
Integer |
|
Recommended |
Female that is pregnant or breastfeeding |
|
1=Yes; 2=No; 3=N/A
|
excs15, expregnt, ieca11_1 |
Query
|
exc_3 |
Integer |
|
Recommended |
Female with a positive pregnancy test at screening or baseline |
1::3
|
1=Yes; 2=No; 3=N/A
|
|
Query
|
exc_4 |
Integer |
|
Recommended |
History during the current MDE of failure to achieve satisfactory response (e.g. less than 50 percent improvement of depression symptoms) to >7 treatment courses of a therapeutic dose of an antidepressant therapy of at least 18 weeks duration, according to the MGH ATRQ, as confirmed by the remote, independent MGH CTNI rater |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_5 |
Integer |
|
Recommended |
Total MADRS score of <20 at the screen visit or the baseline visit, or as assessed by the remote, independent MGH CTNI rater and reported to the site |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_6 |
Integer |
|
Recommended |
Current diagnosis of a substance use disorder (abuse or dependence, as defined by DSM-IV-TR), with the exception of nicotine dependence, at screening or within 6 months prior to screening |
|
1=Yes; 2=No
|
elg_ct_history_dsm, elg_p_history_dsm, exabuse |
Query
|
exc_7 |
Integer |
|
Recommended |
Current diagnosis of Axis I disorders other than dysthymic disorder, generalized anxiety disorder, social anxiety disorder, panic disorder, agoraphobia, binge eating disorder, mild post traumatic stress disorder, mild obsessive compulsive disorder, or specific phobia (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past 6 months or more |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_8 |
Integer |
|
Recommended |
History of bipolar disorder, schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_9 |
Integer |
|
Recommended |
History of anorexia nervosa, bulimia nervosa, or eating disorder nos, within 5 years of screening |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_10 |
Integer |
|
Recommended |
Any Axis I or Axis II Disorder, which at screening is clinically predomidant to their MDD or has been predominant to their MDD at any time within 6 months prior to screening |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_11 |
Integer |
|
Recommended |
In the judgement of the investigator, the subject is considered at significant risk for suicidal behavior during the course of his/her participation in the study |
|
1=Yes; 2=No; -9 = Unknown
|
poma_iec002m |
Query
|
exc_12 |
Integer |
|
Recommended |
Has failed to respond to ECT during the current depressive episode |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_13 |
Integer |
|
Recommended |
Has received VNS at any time prior to screening |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_14 |
Integer |
|
Recommended |
Has dementia, delirium, amnestic, or any other cognitive disorder |
1::3
|
1=Yes; 2=No; 3=Current
|
|
Query
|
exc_15 |
Integer |
|
Recommended |
Has a clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_16 |
Integer |
|
Recommended |
Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation |
|
1=Yes; 2=No;-7=Refused; -9=Unknown
|
exinvmed |
Query
|
exc_17a |
Integer |
|
Recommended |
Known history or current episode of hypertension or hypertension stage 1 as defined by a systolic blood pressure >>140 mmHg or diastolic blood pressure >>90 mmHg at screening and/or randomization on two of three measurements performed during these visits |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_17b |
Integer |
|
Recommended |
Known history or current episode of recent myocardial infarction (within one year) or a history of myocardial infarction |
|
1=Yes; 2=No; -999=Don't know/Missing Data
|
|
Query
|
exc_17c |
Integer |
|
Recommended |
Known history or current episode of syncopal event within the past year |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_17d |
Integer |
|
Recommended |
Known history or current episode of congestive heart failure (CHF) New York Hear Association Criteria >Stage 2 |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_17e |
Integer |
|
Recommended |
Known history or current episode of angina pectoris |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_17f |
Integer |
|
Recommended |
Known history or current episode of heart rate <50 or >105 beats per minute at screening or randomization |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_17g |
Integer |
|
Recommended |
Exclusion 17g |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_18 |
Integer |
|
Recommended |
Chronic lung disease excluding asthma |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_19 |
Integer |
|
Recommended |
Lifetime history of surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system (CNS) disorder (e.g. Alzheimer's or Parkinson's disease), epilepsy, mental retardation, or any other disease/procedure/accident/intervention associated with significant injury to or malfunction of the CNS, or history of significant head trauma within the past two years |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_20a |
Integer |
|
Recommended |
Thyroid stimulating hormone (TSH) outside of the normal limits and clinically significant as determined by the investigator |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_20b |
Integer |
|
Recommended |
Patients with diabetes mellitus who have unstable diabetes mellitus defined as glycosylated hemoglobin (HbA1c) >8.5% at screening, admitted to hospital for treatment of diabetes mellitus or diabetes mellitus - related illness in the past 12 weeks, not under physician care for diabetes mellitus, has not been on the same dose of oral hypoglycaemic drugs and/or diet for the 4 weeks prior to screening |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_20c |
Integer |
|
Recommended |
Any other clinically significant abnormal laboratory result |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_21 |
Integer |
|
Recommended |
History of hypothyroidism and has been on a stable dosage of thyroid replacement medication for less than 2 months prior to screening (subjects on a stable dosage of thyroid replacement medication for at least 2 months or more prior to screening are eligible for enrollment |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_22 |
Integer |
|
Recommended |
History of hyperthyroidism which was treated (medically or surgically) less than 6 months prior to screening |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_23 |
Integer |
|
Recommended |
Any current or past history or any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation |
|
1=Yes; 2=No
|
exmedcon |
Query
|
exc_24 |
Integer |
|
Recommended |
History of positive screening urine test for drugs of abuse at screening: cannabinoids, cocaine, amphetamines, barbiturates, opiates |
1;2
|
1=Yes; 2=No
|
amish_exc2a |
Query
|
exc_25 |
Integer |
|
Recommended |
Patients with exclusionary laboratory values or requiring treatment with exclusionary concomitant psychotropic medications |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_26 |
Integer |
|
Recommended |
Patients on exclusionary concomitant psychotropic medications, the half life of which would not allow sufficient time for patients to have been free of the medication post-taper for five half lives within the maximum screening period (14 days) |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_27 |
Integer |
|
Recommended |
Patients who have participated in studies of ketamine or AZD6765 or other NMDA receptor antagonists for depression and received active treatment |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_28 |
Integer |
|
Recommended |
Patients with narrow angle glaucoma |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_29 |
Integer |
|
Recommended |
Patients with a lifetime history of PCP/Ketamine drug use |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_30 |
Integer |
|
Recommended |
Liver Function Tests higher than 2.5 times upper limit of normal |
1;2
|
1=Yes; 2=No
|
|
Query
|
inc_1 |
Integer |
|
Recommended |
Male or female, 18-65 years of age, inclusive, at screening |
1;2
|
1=Yes; 2=No
|
ieca1, incs8 |
Query
|
inc_2 |
Integer |
|
Recommended |
Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information |
|
1=Yes; 2=No; -9 = Unknown
|
avl_inc01b, incs9, inex_inc6, poma_iec001c |
Query
|
inc_3 |
Integer |
|
Recommended |
Diagnosed with MDD, single or recurrent, and currently experiencing a major depressive episode (MDE) of at least 8 weeks in duration, prior to screening, according to the criteria defined in the DSM-IV-TR |
1;2
|
1=Yes; 2=No
|
|
Query
|
inc_4 |
Integer |
|
Recommended |
Has a history of TRD during the current MDE, as assessed by the investigator and remote centralized rater using the MGH ATRQ |
1;2
|
1=Yes; 2=No
|
|
Query
|
inc_5 |
Integer |
|
Recommended |
Meet the threshold on the total MADRS score of >20 at both the screen visit and the baseline visit, and as confirmed by the remote centralized MGH CTNI rater between the screen visit and the baseline visit |
1;2
|
1=Yes; 2=No
|
|
Query
|
inc_6 |
Integer |
|
Recommended |
In good general health, as ascertained by medical history, physical examination, clinical laboratory evaluations, and ECG |
|
1=Yes; 2=No; -9 = Unknown
|
poma_iec001b |
Query
|
inc_7 |
Integer |
|
Recommended |
If female, a stus of non-childbearing potential or use of an acceptable form of birth control per |
|
1=Yes; 2=No; 3=NA; -9 = Unknown
|
poma_iec001d |
Query
|
inc_8 |
Integer |
|
Recommended |
Body mass index between 18-35 |
1;2
|
1=Yes; 2=No
|
|
Query
|
inc_9 |
Integer |
|
Recommended |
Concurrent psychotherapy will be allowed if the type and frequency of the therapy has been stable for at least 3 months prior to screening and if the type and frequency of the therapy is expected to remain stable during the course of the subject's participation in the study |
1;2
|
1=Yes; 2=No
|
|
Query
|
inc_10 |
Integer |
|
Recommended |
Concurrent hypnotic therapy will be allowed if the therapy has been stable for at least 4 weeks prior to screening and if it is expected to remain stable during the course of the subject's participation in the study |
1;2
|
1=Yes; 2=No
|
|
|
scrfldt |
Date |
|
Recommended |
Date of Screen Failure |
|
|
|
Query
|
scrflinc |
String |
1,250
|
Recommended |
Failed these inclusion criteria: |
|
|
|
Query
|
scrflexc |
String |
500
|
Recommended |
Failed these exclusion criteria: |
|
|
|
Query
|
scrnflpr |
Integer |
|
Recommended |
Select the primary reason for screen failure |
|
|
|
|
scrfloth |
String |
250
|
Recommended |
Other reasons for failure |
|
|
reason_for_failure |
Query
|
state |
Integer |
|
Recommended |
Subject state |
0::2
|
0=Screening; 1=Screened; 2=Failed
|
|
|
subject_group |
String |
30
|
Recommended |
Subject Group_view_KETAMINE_ADVERSE_EVENT_LOG |
|
|
|
Query
|
iec001a |
Integer |
|
Recommended |
Age between 18 and 55 |
0;1;-9
|
0=No; 1=Yes; -9=Unknown
|
elg_ct_age, elg_p_age, poma_iec001a |
Query
|
iec001b |
Integer |
|
Recommended |
Inclusion: Negative Urine Toxicology |
0;1;-9
|
0=No; 1=Yes; -9=Unknown
|
|
Query
|
iec001c |
Integer |
|
Recommended |
Inclusion: No family history of schizophrenia in a first degree relative |
0;1;-9
|
0=No; 1=Yes; -9=Unknown
|
elg_ct_dsm_relative |
Query
|
medprob_eyecolorbl |
String |
50
|
Recommended |
Color blindness? |
|
|
iec002j |
Query
|
iec002a |
Integer |
|
Recommended |
Current or past Axis I or II psychiatric history, (including substance abuse or dependence, with the exception of nicotine dependence) |
0;1;-9
|
0=No; 1=Yes; -9=Unknown
|
ieh002c |
Query
|
iec002b |
Integer |
|
Recommended |
Current (i.e., within the last 3 months) treatment with any psychotropic medications (as specified in protocol) |
0;1;-9
|
0=No; 1=Yes; -9=Unknown
|
ieh002g, inex_exc4, poma_iec002k |
Query
|
iec002c |
Integer |
|
Recommended |
Positive serum pregnancy test, lactation, or lack of use of effective birth control |
0;1;-9
|
0=No; 1=Yes; -9=Unknown
|
avl_exc02k |
Query
|
iec002d |
Integer |
|
Recommended |
Presence or positive history of significant medical illness, including high blood pressure (SBP > 140, DBP > 90), low blood pressure (SBP < 100, DBP < 60), orthostatic blood pressure at baseline (change in mean arterial pressure [1/3 systolic + 2/3 diastolic] of > 20%), and cardiac illness. |
0;1;-7;-9
|
0=No; 1=Yes; -9=Unknown; -7=Refused
|
amish_exc2c |
Query
|
iec002e |
Integer |
|
Recommended |
Presence or positive history of neurological illness, including seizures and mental retardation, or any other disease/procedure/accident/intervention associated with significant injury to or malfunction of the CNS, or history of significant head injury. |
0;1;-9
|
0=No; 1=Yes; -9=Unknown
|
amish_exc2b, elg_ct_neuro_disease, elg_p_neuro_disease, poma_iec002g |
Query
|
hxvio |
Integer |
|
Recommended |
History of violence |
0;1; -9
|
0=No; 1=Yes; -9 = Unknown
|
iec002f, poma_iec002e |
Query
|
iec002g |
Integer |
|
Recommended |
History of recreational ketamine use, recreational PCP use, or an adverse reaction to ketamine. Research participation in more than 5 previous ketamine infusions with limitations as specified in the protocol. |
0;1;-9
|
0=No; 1=Yes; -9=Unknown
|
poma_iec002c |
Query
|
iec002h |
Integer |
|
Recommended |
Contraindication to MRI scanning, including metal implants or claustrophobia. Metal implants, pacemaker, other metal (e.g. shrapnel or surgical prostheses) or paramagnetic objects contained within the body which may present a risk to the subject or interfere with the MR scan (as determined in protocol). |
0;1;-9
|
0=No; 1=Yes; -9=Unknown
|
amish_exc2i, avl_exc02n, elg_ct_metal_implants, elg_p_metal_implants, metallic, poma_iec002i |
Query
|
iec002i |
Integer |
|
Recommended |
Medicinal patch, unleess removed prior to the MR scan |
0;1;-9
|
0=No; 1=Yes; -9=Unknown
|
amish_exc2j, avl_exc02o, poma_iec002j |
|
lab020 |
Date |
|
Recommended |
Date of PI/clinician signature |
|
|
iec004 |
Query
|
iec003a |
Integer |
|
Recommended |
Is the subject eligible to participate in the study? |
|
0=No; 1=Yes; -9=Unknown
|
elg_ct_yn, elg_p_yn, eligible, ieh003a, included |
Query
|
iec003d |
String |
50
|
Recommended |
Other reason not eligible |
|
|
ctl_not_elg, iea003d, ieh003d, notelg_case |
Query
|
cmd005_1 |
Integer |
|
Recommended |
Medication route |
1::7; -9
|
1=Oral; 2=Intramuscular; 3=Intravenous; 4=Subcutaneous; 5=Inhalation; 6=Depot; 7=Other (specify below); -9=Unknown
|
|
Query
|
cmd007_1 |
Integer |
|
Recommended |
Medication units |
1::7; -9
|
1=Capsule/tablet; 2=Milligram; 3=Gram; 4=Cubic cm/mL; 5=Grains; 6=Ounce; 7=Other (specify below);-9=Unknown
|
|
Query
|
cmd008_1 |
Integer |
|
Recommended |
Medication Frequency |
1::7; -9
|
1=Daily/once a day; 2=BID. 2x/day; 3=TID, 3x/day; 4=QID, 4x/day; 5=QHS, every night; 6=PRN, as needed; 7=Other (specify); -9=Unknown
|
|
|
discontinuation_date1 |
Date |
|
Recommended |
Discontinuation Date: |
|
|
cmd010a |
Query
|
rafq1 |
Integer |
|
Recommended |
1. Did participant meet criteria as a responder at Week 12 Assessment? (CGI-I of 1 or 2) |
0;1
|
0=No; 1=Yes
|
|
Query
|
rafq2 |
Integer |
|
Recommended |
2. Did participant meet both Current CGI-S score of 4 or higher and current CGI-I score of 4 or higher |
0;1
|
0=No; 1=Yes
|
incs10c |
Query
|
rafq3 |
Integer |
|
Recommended |
3. Potential Relapse identified on this assessment for this participant? |
0;1
|
0=No; 1=Yes
|
|
|
date_updated |
Date |
|
Recommended |
Date record updated |
|
|
edit_date |
Query
|
exc_26a |
Integer |
|
Recommended |
Patients currently taking a proton pump inhibitor (PPI)/histamine 2 (H2) blocker or with a history of chronic NSAID use. |
|
1=Yes; 2=No
|
exppi |
Query
|
exc_27a |
Integer |
|
Recommended |
Patients with a positive test for Helicobacter pylori (urea breath test). |
1;2
|
1=Yes; 2=No
|
|
Query
|
exc_28a |
Integer |
|
Recommended |
Patients with any of the following gastrointestinal-related findings: a. Clinically evident GI complaints; b. Past hisotry of gastric diseases, Crohn's disease, Ulcerative colitis, and any other clinically relevant GI disease |
|
1=Yes; 2=No
|
exgastr |
Query
|
ctnirc2 |
Integer |
|
Recommended |
Subject passed MGH CTNI rater interview |
1;2
|
1=Yes; 2=No
|
|
Query
|
ctnirc1 |
Integer |
|
Recommended |
Medical Monitor approved subject for randomization |
1;2
|
1=Yes; 2=No
|
|
Query
|
ctnirc3 |
Integer |
|
Recommended |
Does the subject meet SCID Mood Module Criteria? |
1;2
|
1=Yes; 2=No
|
|
Query
|
ieca2_1 |
Integer |
|
Recommended |
Is the patients BMI ? 27? |
0;1
|
0=No; 1=Yes
|
|
Query
|
ieca5_1 |
Integer |
|
Recommended |
Is the patients duration of illness greater than one year, as defined by having initiated antipsychotic treatment at least 1 year prior to enrollment? |
0;1
|
0=No; 1=Yes
|
|
Query
|
ieca6_1 |
Integer |
|
Recommended |
Is the patient currently being treated with one or, no more than, two antipsychotic medications? |
0;1
|
0=No; 1=Yes
|
|
Query
|
ieca6b |
Integer |
|
Recommended |
Has the patients anti-psychotic medication dosages been stable for at least 1 month prior to study entry? |
0;1
|
0=No; 1=Yes
|
|
Query
|
ieca7_1 |
Integer |
|
Recommended |
If the patient is taking antidepressants, mood stabilizers, and/or anxiolytics, has the dosage been stable for at least 1 month prior to study entry? |
0::2
|
0=No; 1=Yes; 2=N/A
|
|
Query
|
ieca8_1 |
Integer |
|
Recommended |
If the patient is on concurrent treatment with drugs known to increase metformin blood levels has the PMO been consulted and eligibility determined for this criterion? |
0::2
|
0=No; 1=Yes; 2=N/A
|
|
Query
|
ieca9_1 |
Integer |
|
Recommended |
Has the patient discontinued previous medication for weight loss one month prior to study entry |
0::2
|
0=No; 1=Yes; 2=N/A
|
|
Query
|
ieca12_1 |
Integer |
|
Recommended |
Has the patient been diagnosed with diabetes mellitus or being treated with insulin or oral hypoglycemics? |
0;1
|
0=No; 1=Yes
|
|
Query
|
ieca13_1 |
Integer |
|
Recommended |
Has the patient been diagnosed with congestive heart failure? |
0;1
|
0=No; 1=Yes
|
|
Query
|
ieca14 |
Integer |
|
Recommended |
Is the patient currently or previously been treated with metformin? |
0;1
|
0=No; 1=Yes
|
|
Query
|
ieca15 |
Integer |
|
Recommended |
Does the patient have a known hypersensitivity to metformin? |
0;1
|
0=No; 1=Yes
|
q13_8a |
Query
|
ieca17 |
Integer |
|
Recommended |
Is the patients Clinical Global Impression Severity, CGI-S, score ? 6? |
0;1
|
0=No; 1=Yes
|
|
Query
|
ieca19 |
Integer |
|
Recommended |
Is the patients fasting glucose > 125? |
0;1
|
0=No; 1=Yes
|
|
Query
|
ieca20 |
Integer |
|
Recommended |
Does the patient have renal impairment, serum creatinine ? 1.5 mg/dL in males; ? 1.4 mg/dL in females, or creatinine estimated glomerular filtration rate, GRF, outside normal limits? |
0;1
|
0=No; 1=Yes
|
|
Query
|
ieca21 |
Integer |
|
Recommended |
Does the patient have hepatic disease, AST or ALT > 1.5 x upper limit of normal, ULN, or total bilirubin > 1.2 x ULN,? |
0;1
|
0=No; 1=Yes
|
|
Query
|
ieca22 |
Integer |
|
Recommended |
Does the patient have metabolic acidosis |
0;1
|
0=No; 1=Yes
|
|
Query
|
ieca23 |
Integer |
|
Recommended |
Has the patient had recent, in the past 30 days, or scheduled radiological studies involving iodinated contrast material? |
0;1
|
0=No; 1=Yes
|
|
Query
|
inex_inc1 |
Integer |
|
Recommended |
Between ages 6 and 17 |
0;1
|
0=No; 1=Yes
|
|
Query
|
inex_inc3 |
Integer |
|
Recommended |
Severity of anxiety symptoms |
0;1
|
0=No; 1=Yes
|
|
Query
|
inex_inc4 |
Integer |
|
Recommended |
Severity of overall impairment |
0;1
|
0=No; 1=Yes
|
|
Query
|
inex_inc5 |
Integer |
|
Recommended |
In good physical health |
0;1
|
0=No; 1=Yes
|
db_inc7 |
Query
|
inex_inc7 |
Integer |
|
Recommended |
Written informed consent age or assent |
0;1;-7;-9
|
0=No; 1=Yes; -9=unknown; -7=refused
|
|
Query
|
inex_exc2 |
Integer |
|
Recommended |
Past diagnosis of disorders |
0;1
|
0=No; 1=Yes
|
|
Query
|
inex_exc3 |
Integer |
|
Recommended |
Current diagnosis of disorders |
0;1
|
0=No; 1=Yes
|
|
Query
|
inex_exc5 |
Integer |
|
Recommended |
Recent treatment with psychotropic meds |
0;1
|
0=No; 1=Yes
|
|
Query
|
inex_exc6 |
Integer |
|
Recommended |
Currently uses psychoactive drugs/alcohol |
0;1
|
0=No; 1=Yes
|
|
Query
|
inex_exc9 |
Integer |
|
Recommended |
Sexually active Female without Birth control |
0;1
|
0=No; 1=Yes
|
|
Query
|
inex_exc10 |
Integer |
|
Recommended |
IQ less than 70 |
0;1
|
0=No; 1=Yes
|
|
Query
|
inmdd |
Integer |
|
Recommended |
IN: meets DSM-IV criteria |
0;1;-7;-9
|
0=No; 1=Yes; -9=unknown; -7=refused
|
db_inc2, inex_inc2 |
Query
|
chartreview021 |
String |
15
|
Recommended |
Suicidal ideation |
|
0=No; 1=Yes,in past week; 2=Yes, >1 week ago; 3=Yes, no time specified; 5 = Yes, in current visit; 9=Not Documented;-888=Not Applicable;-999=Missing;
|
inex_exc7 |
Query
|
completed |
Integer |
|
Recommended |
Checks if completed |
0::3
|
0=No; 1=Yes; 2=Yes, lost; 3=Unverified
|
frmcomp, inex_frmcomp |
Query
|
incs7 |
Integer |
|
Recommended |
Schizophrenia/schizoaffective disorder patient whose clinician is considering long-term treatment with a second-generation antipsychotic medication |
0;1
|
0=No; 1=Yes
|
|
Query
|
incs10 |
Integer |
|
Recommended |
Subject has had an exacerbation of his/her illness within the last 12 months. |
0;1
|
0=No; 1=Yes
|
|
Query
|
incs10b |
Integer |
|
Recommended |
Increased level of care required, defined by an increase in clinic visits, emergency room visits or a change from general outpatient status to day hospital participation |
0;1
|
0=No; 1=Yes
|
|
Query
|
incs10a |
Integer |
|
Recommended |
Hospitalization |
0;1
|
0=No; 1=Yes
|
|
Query
|
excs11 |
Integer |
|
Recommended |
First episode patients. |
0;1
|
0=No; 1=Yes
|
|
Query
|
excs12 |
Integer |
|
Recommended |
Patients with a known allergy to risperidone. |
0;1
|
0=No; 1=Yes
|
db_exc4 |
Query
|
excs13 |
Integer |
|
Recommended |
Patients with a past negative response to risperidone that is not explained by treatment non-adherence. |
0;1
|
0=No; 1=Yes
|
|
Query
|
excs14 |
Integer |
|
Recommended |
Patients with a previous history of failure to respond to an adequate trial of clozapine. |
0;1
|
0=No; 1=Yes
|
|
Query
|
reass19 |
Integer |
|
Recommended |
Experimental research study |
0;1
|
0=No; 1=Yes
|
|
Query
|
reass20 |
Integer |
|
Recommended |
Randomized drug treatment |
0;1
|
0=No; 1=Yes
|
|
Query
|
reass21 |
Integer |
|
Recommended |
Injection |
0;1
|
0=No; 1=Yes
|
|
Query
|
reass22 |
Integer |
|
Recommended |
Denial of need for medication |
0;1
|
0=No; 1=Yes
|
|
Query
|
reass23 |
Integer |
|
Recommended |
Denial of illness |
0;1
|
0=No; 1=Yes
|
|
Query
|
reass24 |
Integer |
|
Recommended |
Study burden |
0;1
|
0=No; 1=Yes
|
|
Query
|
reass25 |
Integer |
|
Recommended |
Desire to be transferred elsewhere |
0;1
|
0=No; 1=Yes
|
|
Query
|
reass26 |
Integer |
|
Recommended |
Uncooperativeness |
0;1
|
0=No; 1=Yes
|
|
Query
|
reass26_1 |
Integer |
|
Recommended |
Does not want to change current meds |
0;1
|
0=No; 1=Yes
|
|
Query
|
other |
Integer |
|
Recommended |
Other prevent dose increase |
0;1;999
|
0 = No; 1 = Yes
|
reass27 |
Query
|
otherspecify |
String |
255
|
Recommended |
Specify other |
|
|
reass27t |
Query
|
intrt |
Integer |
|
Recommended |
Treatment Status Code |
0::2
|
0=Baseline; 1=In Treatment; 2=In Follow-up
|
|
Query
|
trtgrp_p |
Integer |
|
Recommended |
Treatment Group |
1;2
|
1=Long-Acting Injectable Risperidone Microspheres; 2=Second Generation Oral Antipsychotic Medication
|
|
Query
|
days_visit1 |
Integer |
|
Recommended |
Days from Visit 1 |
|
|
dav1scrn |
Query
|
visnum |
Float |
|
Recommended |
Numeric Visit Number |
|
-1.5 = Pre-Screening; -1 = Screening; 0 = Baseline; ## = Visit ## (from 1 to 10); Whole numbers = standard monthly visits; #.001 - #.009 = Unscheduled; #.1 = End of Phase 1; #.2 = End of Phase 2; #.3 = End of Phase 3; #.4 = End of Open Choice Phase; #.5 = End of Study; #.6 = Genetic Analysis; 1000=all visits
|
|
Query
|
diage |
Integer |
|
Recommended |
Major Depressive Disorder Diagnosis Clinical |
|
0=No; 1=Yes
|
mddyn |
Query
|
bpi4a |
Integer |
|
Recommended |
BIPOLAR I DISORDER. |
|
0=no; 1=yes
|
bp1yn |
Query
|
bpii4a |
Integer |
|
Recommended |
BIPOLAR II DISORDER. |
|
0=no; 1=yes; 998=N/A; 999=Missing
|
bp2yn |
Query
|
ga4a |
Integer |
|
Recommended |
GENERALIZED ANXIETY DISORDER. |
|
0=no; 1=yes
|
gadyn |
Query
|
so4a |
Integer |
|
Recommended |
SOCIAL PHOBIA. |
|
0=no; 1=yes
|
spyn |
Query
|
pd4a1 |
Integer |
|
Recommended |
PANIC DISORDER. |
|
0=no; 1=yes
|
pdyn |
Query
|
medhx_ptsd |
Integer |
|
Recommended |
Post Traumatic Stress Disorder |
|
0 = No, 1 = Yes, 2 = Not sure
|
ptsdyn |
Query
|
incage |
Integer |
|
Recommended |
Age between 21 and 65 years of age |
|
0 = No; 1 = Yes
|
|
Query
|
incdx |
Integer |
|
Recommended |
Must meet DSM-IV TR diagnostic criteria for Major Depressive Disorder, Bipolar I or II Depressed, Generalized Anxiety Disorder, Social Phobia, Panic Disorder, or Post Traumatic Stress Disorder |
|
0=no; 1=yes
|
|
Query
|
incshaps |
Integer |
|
Recommended |
Snaith-Hamilton Pleasure Scale (SHAPS) score > 20 |
0;1
|
0=no; 1=yes
|
|
Query
|
incavail |
Integer |
|
Recommended |
Reliable and willing to be available for the duration of the study |
|
0=no; 1=yes
|
|
Query
|
incmbirc |
Integer |
|
Recommended |
If male of childbearing potential, must have undergone surgical sterilization (such as a vasectomy) or agree to use a condom used with a spermicide during participation in the study and for 1 month afterward |
|
0=no; 1=yes
|
|
Query
|
waiverg |
String |
2
|
Recommended |
Was a waiver granted? |
Y;N
|
|
waiver |
|
waivedt |
Date |
|
Recommended |
Date waiver granted |
|
|
|
Query
|
exdrug |
Integer |
|
Recommended |
Use of any antidepressant, antipsychotic, anxiolytic, anticonvulsant, mood stabilizing, muscle relaxant, centrally acting antihistaminergic, stimulant or insomnia medications within 5 half-lives of baseline or at any time during the study |
|
0=no; 1=yes;-7=Refused; -9=Unknown
|
|
Query
|
exmdrug |
Integer |
|
Recommended |
Use of any medication that is primarily metabolized by Cytochrome P450 2C8 within 14 days of baseline or at any time during study. |
|
0=no; 1=yes
|
|
Query
|
eximage |
Integer |
|
Recommended |
Any contraindications to the magnetic resonance imaging procedures |
|
0=no; 1=yes
|
|
Query
|
exurine |
Integer |
|
Recommended |
Positive urine drug screen at any time during the study |
|
0=No; 1=Yes; -9 = Unknown
|
poma_iec002b |
Query
|
exhyper |
Integer |
|
Recommended |
Known hypersensitivity to LY2456302 |
|
0=no; 1=yes
|
|
Query
|
exallerg |
Integer |
|
Recommended |
History of allergy to protocol meds |
|
0=No; 1=Yes
|
|
Query
|
exsalvia |
Integer |
|
Recommended |
History of use of Salvia divinorum or use of Salvia divinorum at any time during the study. |
|
0=no; 1=yes
|
|
Query
|
exsmoke |
Integer |
|
Recommended |
Any smoking of cigarettes within the last month or at any time during the study |
|
0=no; 1=yes
|
|
Query
|
exdx |
Integer |
|
Recommended |
Current/history of a psychotic disorder, current manic or mixed episode, autism spectrum disorders, mental retardation |
|
0=no; 1=yes
|
|
Query
|
exhosp1 |
Integer |
|
Recommended |
Expected to require hospitalization during the course of the study |
|
0=no; 1=yes
|
exhosp |
Query
|
db_inc1 |
Integer |
|
Recommended |
Between age 5 - 17.2 months |
0;1
|
0=No; 1=Yes
|
|
Query
|
db_inc3 |
Integer |
|
Recommended |
Medication free |
0;1
|
0=No; 1=Yes
|
|
Query
|
db_inc4 |
Integer |
|
Recommended |
Free of anticonvulsants |
0;1
|
0=No; 1=Yes
|
|
Query
|
db_inc5 |
Integer |
|
Recommended |
Achieves scores (CGI,ABC,Ritvo-Freeman) |
0;1
|
0=No; 1=Yes
|
|
Query
|
db_inc6 |
Integer |
|
Recommended |
Mental Age of 18 months |
0;1
|
0=No; 1=Yes
|
|
Query
|
db_exc1 |
Integer |
|
Recommended |
IQ below mental age of 18 months |
0;1
|
0=No; 1=Yes
|
|
Query
|
db_exc2 |
Integer |
|
Recommended |
Female with positive Beta HCG test |
0;1
|
0=No; 1=Yes
|
|
Query
|
db_exc3 |
Integer |
|
Recommended |
Prior adequate trial with risperidone |
0;1
|
0=No; 1=Yes
|
|
Query
|
db_exc5 |
Integer |
|
Recommended |
History, neuroleptic malignant syndrome |
0;1
|
0=No; 1=Yes
|
|
Query
|
db_exc8 |
Integer |
|
Recommended |
Weight is less than 20 kg |
0;1
|
0=No; 1=Yes
|
|
Query
|
ol_inc4 |
Integer |
|
Recommended |
Inpatients or outpatients |
0;1
|
0=No; 1=Yes
|
|
Query
|
ol_inc1 |
Integer |
|
Recommended |
Decreased ABC and CGI Improvement |
0;1
|
0=No; 1=Yes
|
|
Query
|
ol_inc5 |
Integer |
|
Recommended |
No need for other psychotropic meds |
0;1
|
0=No; 1=Yes
|
|
Query
|
ol_inc6 |
Integer |
|
Recommended |
Anticonvulsants: stable for 4 wks and seizure free for at least 6 months |
0;1; 999
|
0=No; 1=Yes; 999=NA
|
|
Query
|
prescrn_q13_1 |
Integer |
|
Recommended |
Subject excluded for age |
1;2;-7;-9
|
1=Yes;2=No; -7=refused; -9 = unknown
|
q13_1 |
Query
|
prescrn_q13_7a |
Integer |
|
Recommended |
Subject excluded for unstable AC med |
1;2
|
1=Yes;2=No
|
q13_7a |
Query
|
prescrn_q13_8 |
Integer |
|
Recommended |
Subject excluded for prior trt |
1;2
|
1=Yes;2=No
|
q13_8 |
Query
|
prescrn_q13_8b |
Integer |
|
Recommended |
Subject exluded for Adverse Event |
1;2
|
1=Yes;2=No
|
q13_8b |
Query
|
prescrn_q13_8c |
Integer |
|
Recommended |
Subject exluded for Serious Adverse Event |
1;2
|
1=Yes;2=No
|
q13_8c |
Query
|
prescrn_q13_10 |
Integer |
|
Recommended |
Subject excluded for med free |
1;2
|
1=Yes;2=No
|
q13_10 |
Query
|
prescrn_q13_o |
Integer |
|
Recommended |
Subject excluded for other reason |
1;2
|
1=Yes;2=No
|
q13_o |
Query
|
prescrn_q14 |
Integer |
|
Recommended |
Other action(s) taken |
1;2
|
1=Yes;2=No
|
q14 |
Query
|
prescrn_q15 |
Integer |
|
Recommended |
Will participate, pharm studies |
1;2
|
1=Yes;2=No
|
q15 |
Query
|
prescrn_q16 |
Integer |
|
Recommended |
Will participate, non-pharm studies |
1;2
|
1=Yes;2=No
|
q16 |
Query
|
study |
String |
100
|
Recommended |
Study; The code for each individual study |
|
|
group, studyid |
Query
|
ci_enrolled |
Integer |
|
Recommended |
Participant enrolled |
0;1
|
0=No; 1=Yes
|
enrolled |
Query
|
pcc001 |
Integer |
|
Recommended |
Was follow-up phone call conducted |
0;1;-9
|
0=No; 1=Yes; -9=Unknown
|
|
Query
|
dmg_referral |
Integer |
|
Recommended |
referral source |
1::11;99
|
1=School
; 2=Hospital - Pediatric Psychiatry
; 3=Hospital - Emergency Room
; 4=Hospital - Other Clinic; 5=Other Treatment Center; 6=Friend
; 7=Radio
; 8=Ad in Paper
; 9=Other
;10= poster/flyer; 11=Internet; 99=DK
|
|
|
refothers |
String |
50
|
Recommended |
Referral source: specify |
|
|
|
Query
|
stable_dose |
Integer |
|
Recommended |
Stable Dose for 4 weeks |
0;1;-9
|
0=No;1=Yes;-9=Unknown
|
|
Query
|
iec_hyprisp |
Integer |
|
Recommended |
Hypersensitivity to Risperidone |
0;1;-9
|
0=No;1=Yes;-9=Unknown
|
|
Query
|
appointment_s |
Integer |
|
Recommended |
Appointment scheduled |
0;1;-9
|
0=No;1=Yes;-9=Unknown
|
|
Query
|
appointment_d |
Integer |
|
Recommended |
When appointment was scheduled |
|
days from randomization date
|
|
Query
|
appointment_t |
String |
8
|
Recommended |
Time appointment was scheduled |
|
|
|
Query
|
follow_call |
Integer |
|
Recommended |
When follow up call was conducted |
|
days from randomization date
|
|
Query
|
ieh002d |
Integer |
|
Recommended |
First-degree relative with DSM-5 Autism Spectrum Disorder |
0;1; 2;-9
|
0=No; 1=Yes; 2 = I do not wish to disclose; -9=Unknown
|
|
|
doa_futdt |
String |
20
|
Recommended |
Future date entered (Assessment) |
|
|
elg_ct_doa_futdt, elg_p_doa_futdt |
|
dode |
String |
10
|
Recommended |
Date of Data Entry |
|
|
elg_ct_dode, elg_p_dode |
|
dode_futdt |
String |
20
|
Recommended |
Future date entered (Data Entry) |
|
|
elg_ct_dode_futdt, elg_p_dode_futdt |
Query
|
form_completed |
Integer |
|
Recommended |
Was the form completed? |
1::4
|
1=Yes; 2=No; 3=Unverified; 4 = N/A-Not in age range
|
elg_ct_form_complete, elg_p_form_complete |
Query
|
form_explain |
Integer |
|
Recommended |
Why was this form not completed? |
86::99
|
99=Participant unable to complete due to cognitive impairment; 98=Participant unable to complete due to physical impairment; 97=Participant refused to begin/finish; 96=Participant completed but with less than best effort; 95=Participant unable to be contacted; 94=Participant deceased; 93=Participant withdrew consent; 92=Time constraints; 91=Rater forgot to administer; 90=Missed appointment; 89=Participant was terminated from study; 88=Other;87 = Not Done (reason unspecified); 86 = Not Applicable
|
elg_ct_explain, elg_p_explain |
|
other_reason_nc |
String |
100
|
Recommended |
Other reason form was not completed |
|
|
elg_ct_other_reason_nc, elg_p_other_reason_nc |
Query
|
assessment_complete |
Integer |
|
Recommended |
Complete? |
0::2
|
0=Incomplete; 1=Unverified; 2=Complete
|
eligibility_checklist_case_complete, eligibility_checklist_control_complete |
Query
|
elg_p_dsm |
Integer |
|
Recommended |
DSM-IV/SCID (or DSM 5/SCID) diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, psychotic disorder not otherwise specified , or diagnosis of schizotypal disorder or schizoid personality disorder or the presence of schizotypal/schizoid symptoms documented through the SPQ-B (score of 17 or more) |
0;1
|
0=No; 1=Yes
|
|
Query
|
elg_p_no_change_in_meds |
Integer |
|
Recommended |
No change in antipsychotic medication or decrement in functioning/support level in the last 30 days |
0;1
|
0=No; 1=Yes
|
elg_ct_no_change_in_meds |
Query
|
dem_18t |
Integer |
|
Recommended |
Mental retardation |
0;1
|
1=Yes 0=No
|
elg_ct_iq_71, elg_p_iq_71 |
Query
|
elg_p_prior_psychosurgery |
Integer |
|
Recommended |
Prior psychosurgery |
0;1
|
0=No; 1=Yes
|
elg_ct_prior_psychosurgery |
Query
|
mdga12 |
Integer |
|
Recommended |
Diagnosed with: Diabetes Type I (insulin dependent) |
0;1
|
0=No; 1=Yes
|
elg_ct_type_1_dm, elg_p_type_1_dm |
Query
|
phne_sc_37 |
String |
5
|
Recommended |
Health/ Medical.5. Have you ever had a brain injury (TBI=traumatic brain injury, brain lesion, loss of consciousness for more than 30 minute)? |
Yes;No
|
|
elg_ct_history_head_trauma, elg_p_history_head_trauma |
Query
|
elg_p_debilitating_illness |
Integer |
|
Recommended |
Significantly debilitating medical illnesses (e.g. encephalitis, aneurysms, tumors, or Central Nervous System (CNS) infections) |
0;1
|
0=No; 1=Yes
|
elg_ct_debilitating_illness |
Query
|
elg_p_intellect_disability |
Integer |
|
Recommended |
Suspected DSM-5 intellectual disability based upon clinical interview and psychosocial history |
0;1
|
0=No; 1=Yes
|
elg_ct_intellect_disability |
Query
|
ec12 |
Integer |
|
Recommended |
Exclusion criteria EC12: Is the patient non-English speaking? |
0::2
|
0 = No; 1 = Yes; 2 = Not Assessed
|
elg_ct_eng_speaker, elg_p_eng_speaker |
|
elg_case |
String |
100
|
Recommended |
Eligible specify |
|
|
ctl_elg |
Query
|
elg_ct_dsm |
Integer |
|
Recommended |
Absence of any DSM-5 disorder, which was included previously within the group of DSM-IV-TR Axis I disorders (except for adjustment disorder or a phobic disorder) |
0;1
|
0=No; 1=Yes
|
|
Query
|
iec_years |
Integer |
|
Recommended |
18-60 years old male or female |
0;1
|
0=No; 1=Yes
|
years |
Query
|
major_med |
Integer |
|
Recommended |
Major medical disorder that could affect central nervous system functioning (e.g., decompensated cardiovascular disease, decompensated chronic obstructive pulmonary disease, unstable diabetes, AIDS, cancer within 5 years of the initial diagnosis except for adequately treated basal cell or squamous cell skin carcinoma) |
0;1
|
0=No; 1=Yes
|
|
Query
|
major_neur |
Integer |
|
Recommended |
Major neurological or cognitive disorder (e.g., seizure disorder, brain insults accompanied by loss of consciousness for longer than 30 mins, history of stroke, neurodegenerative disorder) |
0;1
|
0=No; 1=Yes
|
|
Query
|
iec_iq |
Integer |
|
Recommended |
SS < 60 for the WRAT-IV - Word Reading Green Form OR ESL and SS < 60 for the WASI-Matrix Reasoning |
0;1
|
0=No; 1=Yes
|
|
Query
|
ss_matrixreasoningrawscore |
Integer |
|
Recommended |
Matrix Reasoning Raw - Score |
0 :: 35
|
|
wasi_raw |
Query
|
wasi_pass |
Integer |
|
Recommended |
WASI-Matrix Reasoning SS > 60? |
0;1
|
0=No; 1=Yes
|
|
Query
|
wrat_greenpass |
Integer |
|
Recommended |
WRAT-IV - Word Reading Green Form SS > 60? |
0;1
|
0=No; 1=Yes
|
|
Query
|
wr_rawscore |
Integer |
|
Recommended |
Word Reading Raw Score |
0 :: 70;-9;999
|
999 = Missing value
|
wratgreen_raw |
Query
|
esl_registry |
Integer |
|
Recommended |
English is second language (ESL)? |
0;1
|
0=No; 1=Yes
|
|
Query
|
iec_lifetime |
Integer |
|
Recommended |
Lifetime DSM diagnosis of bipolar I disorder (with or without psychotic features) |
0;1
|
0=No; 1=Yes
|
lifetime |
Query
|
iec_capable |
Integer |
|
Recommended |
Capable of completing the study procedures as judged by study investigators |
0;1
|
0=No; 1=Yes
|
capable |
Query
|
iec_healthy |
Integer |
|
Recommended |
Healthy subjects with no personal history of any psychotic or bipolar disorders, recurrent MDD, or a family history of schizophrenia, schizoaffective disorder, or bipolar disorder in first-degree relatives |
0;1;-9;-7
|
0=No; 1=Yes; -7=Refused; -9=Unknown
|
healthy |
Query
|
longitudinal |
Integer |
|
Recommended |
Longitudinal Study |
0;1
|
0=No; 1=Yes, Longitudinal Study
|
|
|
diagnosis_other_specify |
String |
500
|
Recommended |
What other diagnoses has the participant had? |
|
|
|
Query
|
dsmdm |
Integer |
|
Recommended |
Depressed mood |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
irritability |
String |
10
|
Recommended |
Irritability |
Yes; No; Unknown
|
|
|
Query
|
gen_rater_26 |
Integer |
|
Recommended |
Sleep disturbance, especially difficulty falling asleep. |
1;2; 9
|
1 = Yes; 2 = No; 9 =unable to answer
|
|
Query
|
social_anhedonia_present |
String |
10
|
Recommended |
Social anhedonia present |
absent;present
|
|
|
Query
|
cdrs5bu |
Integer |
|
Recommended |
Appetite disturbance: Best Description |
1::5; -9
|
1 = No problems or changes in eating pattern; 2; 3 = Mild but notable change from usual eating habits; 4; 5 = Avoids eating and/or is not hungry most of the time OR describes a noteworthy increase in appetite and/or excessive food intake; -9=incomplete
|
|
Query
|
dyb5 |
Integer |
|
Recommended |
Poor concentration or difficulty making decisions |
0::3; -7
|
0=Inadequate information; 1=Absent or false; 2=Subthreshold; 3=Threshold or true; -7 =refused
|
|
Query
|
q17_b1b |
Integer |
|
Recommended |
Tired worn out or fatigued |
-7;-8;-9;0;1
|
Complete only if primary question equals 1
|
|
Query
|
exambat220 |
Integer |
|
Recommended |
Agitation |
0::3
|
0=None;1=Mild;2=Moderate;3=Severe
|
|
Query
|
adsq6_u |
Integer |
|
Recommended |
Presence of Symptom: Feeling guilty or bad about things (Non-imputed Version) |
0;1
|
0= No; 1= Yes
|
|
Query
|
worthled |
Integer |
|
Recommended |
Worthlessness |
0;1
|
0=No; 1=Yes
|
|
Query
|
aer028a |
Integer |
|
Recommended |
Increased Energy |
0::3; -9
|
0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
|
|
Query
|
scrn_currsi_a |
Integer |
|
Recommended |
Suicide ideation, current |
0;1; -888; -999
|
0=No; 1=Yes; -888=Not Applicable; -999=Missing
|
|
Query
|
medication1_weeks |
Float |
|
Recommended |
Total weeks of medication 1 |
|
|
|
Query
|
medication1_dosage |
String |
150
|
Recommended |
First medication dosage |
|
0 = No medication; 999 = Missing
|
|
Query
|
medication2_dosage |
String |
100
|
Recommended |
Second medication dosage |
|
0 = No medication; 999 = Missing
|
|
Query
|
medication1_name |
String |
500
|
Recommended |
Name first medication that the participant has taken |
|
0 = No medication; 999= Legitimately skipped
|
|
Query
|
medication2_name |
String |
500
|
Recommended |
Name second medication that the participant has taken |
|
0 = No medication; 999= Legitimately skipped
|
|
Query
|
week |
Float |
|
Recommended |
Week in level/study |
|
99=week 10-week 14
|
|
Query
|
p2i9 |
Integer |
|
Recommended |
Major Depressive Episode - Current episode psychosis |
1;2
|
1=no;2=yes
|
|
Query
|
icdcd40 |
Integer |
|
Recommended |
Did the patient have a CDRS Score of 40 or greater at the wk 0 visit? |
0;1
|
0 = Not Checked; 1 = Checked
|
|
Query
|
icdssri |
Integer |
|
Recommended |
Did the patient have an adequate trial of only 1 SSRI? |
0;1
|
0 = Not Checked; 1 = Checked
|
|
Query
|
icdcdrs |
Integer |
|
Recommended |
Did the patient's depression fail to improve beyond the CDRS requirements (i.e. score decreased less than 30%) within the two-week screening period (between wk -2 and wk 0)? |
0;1
|
0 = Not Checked; 1 = Checked
|
|
Query
|
i1e15 |
Integer |
|
Recommended |
DSM-IV Developmental Disorder |
0;1
|
0 = Not Checked; 1 = Checked
|
|
Query
|
e8 |
Integer |
|
Recommended |
Excluded because of Weight |
0;1; -9
|
0 = Not Checked; 1 = Checked; -9 = Unknown
|
poma_iec002n |
Query
|
i1e3 |
Integer |
|
Recommended |
History of failure to respond to 2 or more SSRIs |
0;1
|
0 = Not Checked; 1 = Checked
|
|
Query
|
i1e1 |
Integer |
|
Recommended |
History of failure to respond to CBT |
0;1
|
0 = Not Checked; 1 = Checked
|
|
Query
|
i1e2 |
Integer |
|
Recommended |
History of failure to respond to venlafaxine |
0;1
|
0 = Not Checked; 1 = Checked
|
|
Query
|
i1e7 |
Integer |
|
Recommended |
Organic Mental Disorder |
0;1
|
0 = Not Checked; 1 = Checked
|
|
Query
|
i2 |
Integer |
|
Recommended |
Six Weeks of Adequate Treatment |
0;1
|
0 = Not Checked; 1 = Checked
|
|
Query
|
i2e14 |
Integer |
|
Recommended |
Time commitment - not willing to come in to clinic for 12 weeks |
0;1
|
0 = Not Checked; 1 = Checked
|
|
Query
|
icdcomp |
Integer |
|
Recommended |
Was the patient compliant with the SSRI? |
0;1
|
0 = Not Checked; 1 = Checked
|
|
Query
|
icddsm |
Integer |
|
Recommended |
Was the patient diagnosed with Major Depressive Disorder (MDD) and/or Dysthymia according to DSM-IV criteria at the wk 0 visit? |
0;1
|
0 = Not Checked; 1 = Checked
|
|
Query
|
prerand |
Integer |
|
Recommended |
Was the patient pre-randomized? |
0;1
|
0 = Not Checked; 1 = Checked
|
|
Query
|
exclmed |
Integer |
|
Recommended |
Concomitant use of excluded medications |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
icdhido |
Integer |
|
Recommended |
If the patient was taking a concomitant medication allowed by the study Protocol, was the dose within the allowed limits? |
0;1
|
0 = Not Checked; 1 = Checked
|
|
Query
|
amish_inc1a |
Integer |
|
Recommended |
Male or Female, ages 18-59 |
0; 1; -9
|
0=No; 1=Yes; -9= NK
|
|
Query
|
amish_inc1b |
Integer |
|
Recommended |
Subject is from the Old-Order Amish population |
0; 1; -9
|
0=No; 1=Yes; -9= NK
|
|
Query
|
amish_inc1c |
Integer |
|
Recommended |
Meets DSM-5 diagnostic criteria for psychotic disorder, including SCZ/schizoaffective disorder (SAD) or psychotic disorder not elsewhere classified (PDNEC) |
0; 1; -9
|
0=No; 1=Yes; -9= NK
|
|
Query
|
amish_inc1d |
Integer |
|
Recommended |
Genetically confirmed that patient carries CNTNAP2 mutation |
0; 1; -9
|
0=No; 1=Yes; -9= NK
|
|
Query
|
amish_inc1e |
Integer |
|
Recommended |
A relative will be willing to be part of the study and this relative will travel with the participant to CUMC in New York City and back to Lancaster, PA -- Ascertained by history |
0; 1; -9
|
0=No; 1=Yes; -9= NK
|
|
Query
|
amish_inc1f |
Integer |
|
Recommended |
In the judgment of the treating physician of the participant, as well as the evaluating consenter, the patient is stable enough to travel and participate in the study |
0; 1; -9
|
0=No; 1=Yes; -9= NK
|
|
Query
|
amish_inc1g |
Integer |
|
Recommended |
Genetically confirmed that patient does not carry CNTNAP2 mutation |
0; 1; -9
|
0=No; 1=Yes; -9= NK
|
|
Query
|
amish_inc1h |
Integer |
|
Recommended |
Has first-degree relative of Old-Order Amish subject with CNTNAP2 mutation |
0; 1; -9
|
0=No; 1=Yes; -9= NK
|
|
Query
|
amish_exc2d |
Integer |
|
Recommended |
Low hemoglobin (Hb < 13 g/dL in males, Hb < 11 g/dL in females) |
0; 1; -9
|
0=No; 1=Yes; -9= NK
|
|
Query
|
amish_exc2e |
Integer |
|
Recommended |
Lifetime exposure to radiation in the workplace, or lifetime history of participation in nuclear medicine procedures, including research protocols. (if previously exposed to radiation due to research studies, please refer to exclusions in protocol) |
0; 1; -9
|
0=No; 1=Yes; -9= NK
|
|
Query
|
amish_exc2f |
Integer |
|
Recommended |
Blood donation within eight weeks of study |
0; 1; -9
|
0=No; 1=Yes; -9= NK
|
|
Query
|
amish_exc2g |
Integer |
|
Recommended |
Presence of clinically significant brain abnormalities |
0; 1; -9
|
0=No; 1=Yes; -9= NK
|
|
Query
|
amish_exc2h |
Integer |
|
Recommended |
Positive Pregnancy test (for female subjects of child-bearing age who are not surgically sterilized and between menarche and 1 year postmenopausal) |
0; 1; -9
|
0=No; 1=Yes; -9= NK
|
poma_iec002h |
Query
|
amish_exc2k |
Integer |
|
Recommended |
Use of the medications that would interfere with mGluR5 binding, including lamotrigine, gabapentin, topiramate, phenobarbital, pregabalin, zonisamide, N-acetylcysteine, D-cycloserine, clozapine |
0; 1; -9
|
0=No; 1=Yes; -9= NK
|
|
Query
|
amish_exc2l |
Integer |
|
Recommended |
Affected subjects: Current treatment with clozapine and/or medications other than antipsychotics/PRN anxiolytics |
0; 1; -9
|
0=No; 1=Yes; -9= NK
|
|
Query
|
amish_exc2m |
Integer |
|
Recommended |
Unaffected subjects: Lifetime history of antipsychotic or antidepressant use |
0; 1; -9
|
0=No; 1=Yes; -9= NK
|
|
Query
|
iec_lifetime_psycq |
Integer |
|
Recommended |
Lifetime DSM diagnosis of bipolar I disorder (with psychotic features) |
0;1
|
0=No; 1=Yes
|
|
Query
|
asap10c |
Integer |
|
Recommended |
outside clinicians/services: Outside psychotherapy for patient |
0;1
|
0 = No;1 = Yes
|
|
Query
|
inc_5a |
Integer |
|
Recommended |
Is the minimum score on the HAM-D at screen and at baseline greater than or equal to 20 |
0;1
|
0=No; 1=Yes
|
|
Query
|
gafcutoff |
Integer |
|
Recommended |
GAF rating of 60 or below (moderate or worse impairment) |
0;1
|
0=No; 1=Yes
|
|
Query
|
depdecrease |
Integer |
|
Recommended |
Did the total score on the HAM-D decrease by 25% or more between screening and baseline |
0;1
|
0=No; 1=Yes
|
|
Query
|
disp3 |
Integer |
|
Recommended |
Is this subject being seen at a satellite site? |
1;2
|
1=Yes; 2=No
|
|
Query
|
reas09 |
Integer |
|
Recommended |
Met exclusion criteria |
0;1
|
0=No; 1=Yes
|
|
Query
|
reas08 |
Integer |
|
Recommended |
Failed inclusion criteria |
0;1
|
0=No; 1=Yes
|
|
Query
|
ran002 |
Integer |
|
Recommended |
Was the subject randomized? |
0::3; -9
|
0=No; 1=Yes; -9=unknown; 2=No meds; 3=No community care
|
|
Query
|
exclus2 |
Integer |
|
Recommended |
Exclusion Criteria: Is confined to a jail or to a juvenile justice facility or county-ordered treatment |
0;1
|
0=No; 1=Yes
|
|
Query
|
exclus3 |
Integer |
|
Recommended |
Exclusion Criteria: Is already in treatment and the current treatment seems to be effective in treating their depression and decreasing risk for recurrence of suicidal behavior |
0;1
|
0=No; 1=Yes
|
|
Query
|
exclus6 |
Integer |
|
Recommended |
Exclusion Criteria: History of intolerance to all of the medications or a history of failure to respond to an adequate trial of all the trial medications being used in the algorithm |
0;1
|
0=No; 1=Yes
|
|
Query
|
exclus8 |
Integer |
|
Recommended |
Exclusion Criteria: Subject or parent does not speak English or Spanish |
0;1; -7;-9
|
0=No; 1=Yes;-7=Refused; -9=Unknown
|
|
Query
|
exclus10 |
Integer |
|
Recommended |
Exclusion Criteria: Another family member is participating in trial |
0;1
|
0=No; 1=Yes
|
|
Query
|
inclus1 |
Integer |
|
Recommended |
Inclusion Criteria: Age 12 to 18 years old (inclusive, at time of consent) DSM IV Major Depressive Disorder (MDD), Dysthymic Disorder, Depressive Disorder NOS. It must be clinically determined that depression is the primary diagnosis (depressive disorder causes the most significant level of distress or impairment) |
0;1
|
0=No; 1=Yes
|
|
Query
|
inclus4 |
Integer |
|
Recommended |
Inclusion Criteria: Estimated IQ>=70. (average IQ subtest score >=6 on the voccabulary and block design subtests of the WISC-IV). |
0;1
|
0=No; 1=Yes
|
|
Query
|
inclus5 |
Integer |
|
Recommended |
Inclusion Criteria: Subjects will have continuously resided with a primary caretaker (defined as a parent(s), close relative functioning in loco parentis, legal guardian, or foster parent) who was known the teenager well for at least 3 months before study entry and is legally able to sign the consent form |
0;1;-7;-9
|
0=No; 1=Yes; -9=unknown; -7=refused
|
|
Query
|
scrnfail |
Integer |
|
Recommended |
Subject does not meet Inclusion/Exclusion Criteria and is a Screen Fail. |
0;1
|
0=No; 1=Yes
|
|
Query
|
strcmtw |
Integer |
|
Recommended |
If yes: is the subject being referred to the Steering Committee for review? |
0;1
|
0=No; 1=Yes
|
|
Query
|
subrev |
Integer |
|
Recommended |
Was the subject reviewed by Committee? |
0;1;9
|
0=No; 1=Yes; 9=NA
|
|
Query
|
commitday |
Integer |
|
Recommended |
Date of Committee Meeting (days from baseline) |
|
|
|
Query
|
subrand |
Integer |
|
Recommended |
Should this subject be randomized to the 2-arm med inclusive option or the 3-arm option? (1=2-arm med inclusive (on a current antidepressant) option, 2=3-arm (not on a current antidepressant) option) |
|
|
|
Query
|
days_baseline |
Integer |
|
Recommended |
Days since baseline |
|
|
|
Query
|
sui3mos |
Integer |
|
Recommended |
suicide attempt last 3 mos |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
enrolln |
Integer |
|
Recommended |
Was subject enrolled |
0;1
|
0=No; 1=Yes
|
|
Query
|
excl03 |
Integer |
|
Recommended |
Significant medical condition |
0;1;-7;-9
|
0=No; 1=Yes; -7=refused; -9=unknown
|
poma_iec002f |
Query
|
tourettes_symptoms |
Integer |
|
Recommended |
Tourette's syndrome: Had symptoms |
0;1;-7;-8;-9
|
0 = No; 1 = Yes; -7 = Don't know; -8 = Refused to answer; -9 = Does not apply
|
|
Query
|
excl06 |
Integer |
|
Recommended |
Subject weighs less than 16 kg |
0;1;-7;-9
|
0=No; 1=Yes; -7=refused; -9=unknown
|
|
Query
|
excl07 |
Integer |
|
Recommended |
Hypersensitive to Guanfacine |
0;1;-7;-9
|
0=No; 1=Yes; -7=refused; -9=unknown
|
|
Query
|
excl08 |
Integer |
|
Recommended |
Exclusion criteria exception used for this subject ? |
0;1;-7;-9
|
0=No; 1=Yes; -7=refused; -9=unknown
|
|
Query
|
incl02 |
Integer |
|
Recommended |
Age 4 years 6 months to 14 years of age inclusive |
0;1
|
0=No; 1=Yes
|
|
Query
|
incl04 |
Integer |
|
Recommended |
Med free CGI for PDD >= 4 |
0;1;-7;-9
|
0=No; 1=Yes; -7=refused; -9=unknown
|
|
Query
|
incl05 |
Integer |
|
Recommended |
Meet parent and teacher SNAP-IV criteria |
0;1;-7;-9
|
0=No; 1=Yes; -7=refused; -9=unknown
|
|
Query
|
incl08 |
Integer |
|
Recommended |
Fluent phrase speech
Child must be able to adequately communicate his needs. Child must demonstrate "fluent phrase speech" (the ability to adequately communicate he/her needs). |
0;1;-7;-9
|
1 = YES; 0 = NO; -7 = refused; -9 = unknown
|
|
Query
|
incl09 |
Integer |
|
Recommended |
2.5 hours per day school
Current participation in a pre-school, day care group setting or other school program at least two half days per week.
i. Also, the child may be accepted if child had been in a preschool program but was expelled in the past three months. |
0;1;-7;-9
|
1 = YES; 0 = NO; -7 = refused; -9 = unknown
|
|
Query
|
incl10 |
Integer |
|
Recommended |
Teacher to make valid assessments
Current participation in a pre-school, day care group setting or other school program. One teacher must be able to be identified who spends sufficient time with the patient to be able to make valid assessments.
i. Also, the child may be accepted if child had been in a preschool program but was expelled in the past three months (These children will not require teacher's Conners scales [INCL04] for inclusion, but the prior teacher's ratings will be sought for baseline if there is no other teacher at that time). |
0;1;-7;-9
|
1 = YES; 0 = NO; -7 = refused; -9 = unknown
|
|
Query
|
incl11 |
Integer |
|
Recommended |
8 same-aged peers
Current participation in a pre-school, day care group setting or other school program where class includes at least 8 same-aged peers. Also, the child may be accepted if child had been in a preschool program but was expelled in the past three months. |
0;1;-7;-9
|
1 = YES; 0 = NO; -7 = refused; -9 = unknown
|
|
Query
|
ss_q3 |
Integer |
|
Recommended |
Meet Inclusion and not exclusion |
0;1
|
0 = NO; 1 = YES
|
|
Query
|
ci_continue |
Integer |
|
Recommended |
Participant continuing in study |
0; 1
|
0=No; 1=Yes
|
|
|
np_reason_not_continu |
String |
500
|
Recommended |
Reason for not continuing |
|
|
|
Query
|
q1_11 |
Integer |
|
Recommended |
Has child ever been diagnosed with Rett Disorder or Childhood Disintegrative Disorder? |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
mini_other2 |
Integer |
|
Recommended |
Other specified schizophrenia spectrum and other psychotic disorder: lifetime |
0;1
|
0=No; 1=Yes
|
|
Query
|
exclus7 |
Integer |
|
Recommended |
Current diagnosis of major depression, obsessive-compulsive disorder, or substance abuse (which would require alternative treatment) |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
commitd1 |
Integer |
|
Recommended |
Date of Committee meeting (days since randomization |
|
|
|
Query
|
sigd1 |
Integer |
|
Recommended |
Physician/PI signature date (days since randomization) |
|
|
|
Query
|
weight_std |
Float |
|
Recommended |
Weight - Standard Unit |
|
-1 = Not known; 999 = Missing
|
|
Query
|
dsm_diag |
Integer |
|
Recommended |
DSM-IV PDD Diagnosis, type |
1::3
|
1=Autistic Disorder; 2=Asperger's; 3=PDD-NOS
|
|
Query
|
cgisresp |
Integer |
|
Recommended |
CGIS Response |
|
CGI Response: CS16<=3, or CS16=4 and Change from Phase 1/1A baseline is at least -2; 1=Yes for all records meeting this criteria
|
|
Query
|
outheapr |
Integer |
|
Recommended |
General Services Use: Outpatient health provider |
0;2
|
0 = No; 2 = Yes
|
|
Query
|
iq |
Integer |
|
Recommended |
IQ score as defined by the completion of an appropriate assessement |
|
|
|
Query
|
pdas_bb_ma |
Integer |
|
Recommended |
Mental Age |
|
|
|
Query
|
ruppage |
Integer |
|
Recommended |
Male or Female between the ages of 4 and 13 years |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
inclus2 |
Integer |
|
Recommended |
Body weight greater than or equal to 14 kg (30.8 lbs) |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
inclus3 |
Integer |
|
Recommended |
DSM-IV Diagnosis of Autistic Disorder, Asperger's Disorder, or Pervasive Development Disorder-NOS |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
pabcirr |
Float |
|
Recommended |
Score on Irritability subscale of the Parent-rated Aberrant Behavior Checklist (PABC) |
|
|
|
Query
|
inclus_pabcirr |
Integer |
|
Recommended |
Score greater than or equal to 18 on Irritability subscale of the Parent-rated Aberrant Behavior Checklist |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
inclus7 |
Integer |
|
Recommended |
Medication-free for at least two weeks for all psychotropic medications (four weeks for fluoxetine or depot neuroloeptics); Exception: children taking clonidine/catapres at bedtime for sleep only require a medication-free period of 5 days - following an appropriate taper |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
inclus9 |
Integer |
|
Recommended |
An IQ greater than or equal to 35 or mental age greater than or equal to 18 months as measured by the Stanford-Binet 5, Leiter-R, or Mullen |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
chkone9 |
Integer |
|
Recommended |
How was IQ or mental age determined? |
1::3
|
1 = Stanford-Binet; 2 = Mullen; 3 = Leiter
|
|
Query
|
subaccep |
Integer |
|
Recommended |
If subject reviewed by committee, was the subject accepted for enrollment? |
0;1
|
0 = No; 1 = Yes
|
|
|
schizophrenia_diagnosis |
String |
10
|
Recommended |
Schizophrenia (N=no diagnosis for any first degree relative; Y=positive lifetime diagnosis for one or more first degree relatives) |
|
N = No diagnosis for any first degree relative; Y = Positive lifetime diagnosis for one or more first degree relatives; NK=not known
|
poma_iec002d |
Query
|
clau |
Integer |
|
Recommended |
Have claustrophobia |
0;1; -9
|
0=No; 1=Yes; -9 = Unknown
|
poma_iec002l |
Query
|
poma_iec002a |
Integer |
|
Recommended |
Current or past Axis I psychiatric history (including substance abuse or dependence, with the exception of nicotine dependence) |
0;1;-9
|
0=No; 1=Yes; -9 = Unknown
|
|
Query
|
poma_iec002o |
Integer |
|
Recommended |
Subthreshold PharmacoBOLD response (defined as 0.5% peak ketamine response) during screening ketamine infusion |
0;1;-9
|
0=No; 1=Yes; -9 = Unknown
|
|
Query
|
cigarette_30day_smoking |
Integer |
|
Recommended |
Now think about the past 30 days, including today. During the past 30 days, have you smoked part or all of a roll-your-own tobacco cigarette? PX030801_30Day_Cigarette_Smoking |
|
1=Yes; 2=No; 99=DK/refused
|
exsmoke1 |
Query
|
incdx1 |
Integer |
|
Recommended |
Must meet DSM-IV TR dx criteria for specific mood disorder |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
exinvmed1 |
Integer |
|
Recommended |
Use of investigational drugs within 3 months of study start |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
exallerg1 |
Integer |
|
Recommended |
Hx of severe allergic or multiple adverse drug reactions |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
phq |
Float |
|
Recommended |
Sum Of PHQ 1-9 |
|
(Patient Health Questionnaire) 1-9
|
|
Query
|
alcq |
Integer |
|
Recommended |
Sum of Alcohol Use Items |
|
|
|
Query
|
ec36 |
Integer |
|
Recommended |
Exclusion criteria EC36: Does the patient have a past or current diagnosis of psychotic disorder, including schizophrenia-spectrum disorder, psychotic major depression, or an organic psychotic disorder? |
0::2
|
0 = No; 1 = Yes; 2 = Not Assessed
|
|
|
scid5_dis1_other_icd10 |
String |
10
|
Recommended |
ICD10 code |
|
|
|
Query
|
ad42 |
Integer |
|
Recommended |
ALCOHOL DEPENDENCE. Withdrawal, as manifested by either of the following: 1) The characteristic withdrawal syndrome for alcohol (Criteria A and B). 2) Alcohol or sedatives taken to relieve or avoid withdrawal symptoms. |
0;1
|
0=no; 1 = Yes
|
|
Query
|
sd31 |
Integer |
|
Recommended |
Clinical Data: Inclusion: Age above 18 years |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
sd32 |
Integer |
|
Recommended |
Clinical Data: Inclusion: Site patient |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
sd34 |
Integer |
|
Recommended |
Clinical Data: Inclusion: Score PHQ: Low (5-9) |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
sd35 |
Integer |
|
Recommended |
Clinical Data: Inclusion: Score PHQ: Moderate (10-14) |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
sd36 |
Integer |
|
Recommended |
Clinical Data: Inclusion: Score PHQ: Moderate-Severe (15-19) |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
sd37 |
Integer |
|
Recommended |
Clinical Data: Inclusion: Score PHQ: Severe (20-27) |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
sd39 |
Integer |
|
Recommended |
Clinical Data: Inclusion: Score AUDIT (8 or more) |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
sd42 |
Integer |
|
Recommended |
Exclusion Criteria: Express suicidal intention |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
sd43 |
Integer |
|
Recommended |
Exclusion Criteria: Intoxication |
0;1
|
0 = No; 1 = Yes
|
|
|
tts_30 |
String |
200
|
Recommended |
Are you currently taking any other prescriptions, over the counter medications, or supplements? If yes, please describe: |
|
|
incl_excl_concom_meds |
Query
|
incl_excl_grp |
Integer |
|
Recommended |
Participant group |
1::3
|
1 = NewTics ; 2 = Tourette Syndrome = Chronic Tic Disorders ; 3 = Tic-free control
|
|
Query
|
incl_excl_age |
Integer |
|
Recommended |
Inclusion Criteria: Age 5-10 years old |
|
0 = No; 1 = Yes
|
|
Query
|
incl_excl_tics |
Integer |
|
Recommended |
New Tics Group: Tics now, but developed them only in the past 6 months. |
|
0 = No; 1 = Yes
|
|
Query
|
incl_excl_tsctd |
Integer |
|
Recommended |
Existing Tourette Syndrome/Chronic Tic Disorder Control Group: Meets DSM-5 criteria for Tourette |
|
0 = No; 1 = Yes
|
|
Query
|
incl_excl_tsctd_match |
Integer |
|
Recommended |
Existing Tourette Syndrome/Chronic Tic Disorder Control Group: Matched to children from the New Tics group on age (within 1 year), sex, handedness, and ADHD status (i.e., any ADHD diagnosis vs no ADHD diagnosis). |
|
0 = No; 1 = Yes
|
|
Query
|
incl_excl_tfcg_0tics |
Integer |
|
Recommended |
Tic-free Control Group : No history of tic |
|
0 = No; 1 = Yes
|
|
Query
|
incl_excl_tfcg_match |
Integer |
|
Recommended |
Tic-free Control Group : Matched to children from the New Tics group on age (within 1 year), sex, handedness, and ADHD status. |
|
0 = No; 1 = Yes
|
|
Query
|
incl_excl_sec_tics |
Integer |
|
Recommended |
Exclusion Criteria: Secondary tics |
|
0 = No; 1 = Yes
|
|
Query
|
incl_excl_migraine |
Integer |
|
Recommended |
Exclusion Criteria: Another neurological disorder (not counting migraine) |
|
0 = No; 1 = Yes
|
|
Query
|
incl_excl_brain_disease |
Integer |
|
Recommended |
Exclusion Criteria: Structural brain disease |
|
0 = No; 1 = Yes
|
|
Query
|
incl_excl_system |
Integer |
|
Recommended |
Exclusion Criteria: Severe systemic illness |
|
0 = No; 1 = Yes
|
|
Query
|
incl_excl_ess_trem |
Integer |
|
Recommended |
Exclusion Criteria: Other movement disorders including essential tremor |
|
0 = No; 1 = Yes
|
|
Query
|
incl_excl_nonprof |
Integer |
|
Recommended |
Exclusion Criteria: Nonproficiency in the English language |
|
0 = No; 1 = Yes
|
|
Query
|
incl_excl_disability |
Integer |
|
Recommended |
Exclusion Criteria: Intellectual disability, ASD, substance dependence, current substance abuse, primary psychotic illness, bipolar disorder or current major depression |
|
0 = No; 1 = Yes
|
|
Query
|
incl_excl_meds |
Integer |
|
Recommended |
Exclusion Criteria: Psychoactive meds |
|
0 = No; 1 = Yes
|
|
Query
|
incl_excl_med_change |
Integer |
|
Recommended |
Exclusion Criteria: Psychoactive meds: Change in dose in the past month? |
|
0 = No; 1 = Yes
|
|
Query
|
incl_excl_disab_spec |
Integer |
|
Recommended |
Exclusion Criteria: Select the excluding diagnosis: |
1::7
|
1 = Intellectual disability ; 2 = ASD severe enough to preclude meaningful study participation. ; 3 = Substance dependence ; 4 = Current substance abuse ; 5 = Primary psychotic illness ; 6 = Bipolar disorder ; 7 = Current major depression
|
|
Query
|
incl_excl_first |
Integer |
|
Recommended |
Current or past tic disorder in the subject or a first-degree relative |
|
0 = No ; 1 = Yes ; 3 = Not applicable
|
|
|
incl_excl_ |
String |
500
|
Recommended |
Delay on morning of scan |
|
|
|
Query
|
incl_excl_reviewed |
Integer |
|
Recommended |
Reviewed by P.I.? |
|
0 = No; 1 = Yes
|
|
Query
|
incl_excl_eligible |
Integer |
|
Recommended |
Was the subject deemed eligible for study by the P.I.? |
|
0 = No; 1 = Yes
|
|
Query
|
hepbc |
Integer |
|
Recommended |
Do you currently have Hepatitis B or C, or other serious chronic liver disease? |
0;1
|
0= No; 1= Yes
|
avl_exc02e |
Query
|
smoke_current |
Integer |
|
Recommended |
Is the child a current smoker |
0;1;9
|
1 = Yes; 0 = No; 9 = Unknown
|
avl_exc02m |
|
strconkidney |
String |
5
|
Recommended |
Does the child/patient have kidney disease? |
|
|
avl_exc02f |
Query
|
avl_inc01a |
Integer |
|
Recommended |
Age between 18 and 50 |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
avl_inc01c |
Integer |
|
Recommended |
Medically stable for study participation |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
avl_inc01d |
Integer |
|
Recommended |
Male or female willing to use qualified methods of contraception for the study duration and up to two months after its end |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
avl_inc01e |
Integer |
|
Recommended |
DSM-V diagnosis of schizophrenia or schizoaffective disorder |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
avl_inc01f |
Integer |
|
Recommended |
RBANS > 62 |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
avl_inc01g |
Integer |
|
Recommended |
Taking an antipsychotic medication other than clozapine at a stable dose for at least four weeks |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
avl_inc01h |
Integer |
|
Recommended |
Judged clinically not to be at significant suicide or violence risk |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
avl_exc02a |
Integer |
|
Recommended |
ECG abnormality that is clinically significant |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
avl_exc02b |
Integer |
|
Recommended |
Abnormal physical examination |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
avl_exc02c |
Integer |
|
Recommended |
Current Clozapine use |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
avl_exc02d |
Integer |
|
Recommended |
Hepatitis or known HIV Positive |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
avl_exc02g |
Integer |
|
Recommended |
Presence of positive history of significant medical or neurological illness |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
avl_exc02h |
Integer |
|
Recommended |
Gastrointestinal Illness |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
avl_exc02i |
Integer |
|
Recommended |
Positive toxicology screen for any substance of abuse |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
avl_exc02j |
Integer |
|
Recommended |
Substance abuse (excluding nicotine) within the last 90 days |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
avl_exc02l |
Integer |
|
Recommended |
Participation in study of investigational medication/device within four weeks |
0;1
|
0 = No; 1 = Yes
|
|
|
exclusion_bdd_h |
Integer |
|
Recommended |
Exclusion Criteria: Metallic implants or other contraindications to MRI |
0;1; 888
|
0= Unchecked; 1= Checked; 888 = Not assessed - patient was ineligible
|
incl_excl_contra_mri |
|
incl_excl_ortho |
Integer |
|
Recommended |
Conditions that would interfere with MRI of the brain (such as orthodontia) |
0;1
|
0 = No; 1 = Yes
|
|
|
inelgs |
String |
250
|
Recommended |
Ineligible reason |
|
|
incl_excl_excl_reason |
|
hst_ect |
Integer |
|
Recommended |
History of ECT treatment |
0;1
|
0 = no; 1 = yes
|
|
|
crest_inc8 |
Integer |
|
Recommended |
Are likely able to adhere to the intervention schedule |
1;2
|
1=Yes; 2=No
|
|
|
crest_inc9 |
Integer |
|
Recommended |
Meet the MST safety criteria |
1;2
|
1=Yes; 2=No
|
|
|
crest_inc10 |
Integer |
|
Recommended |
If a woman of child-bearing potential: is willing to provide a negative pregnancy test and agrees not to become pregnant during trial participation |
1::3
|
1=Yes; 2=No; 3=Not applicable
|
|
|
crest_exc1 |
Integer |
|
Recommended |
Have a history of MINI diagnosis of substance dependence or abuse within the past three months |
1;2
|
1=Yes; 2=No
|
|
|
crest_exc2 |
Integer |
|
Recommended |
Have a concomittant major unstable illness |
1;2
|
1=Yes; 2=No
|
|
|
crest_exc3 |
Integer |
|
Recommended |
Are pregnant or intend to get pregnant during the study |
1;2
|
1=Yes; 2=No
|
|
|
crest_exc4 |
Integer |
|
Recommended |
Have a MINI diagnosis of any primary psychotic disorder |
1;2
|
1=Yes; 2=No
|
|
|
crest_exc5 |
Integer |
|
Recommended |
Have a MINI diagnisis of obsessive compulsive disorder, or post-traumatic stress disorder deemed to be primary and causing more functional impairment than the depressive disorder |
1;2
|
1=Yes; 2=No
|
|
|
crest_exc6 |
Integer |
|
Recommended |
Have probable dementia based on study investigator assessment |
1;2
|
1=Yes; 2=No
|
|
|
crest_exc7 |
Integer |
|
Recommended |
Have any significant neurobiological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm |
1;2
|
1=Yes; 2=No
|
|
|
crest_exc8 |
Integer |
|
Recommended |
Present with a medical condition, a medication, or a laboratory abnormality that could cause a major depressive episode or significant cognitice impairment in the opinion of the investigator |
1;2
|
1=Yes; 2=No
|
|
|
crest_exc9 |
Integer |
|
Recommended |
Have an intracranial implant or any other metal object within or near the head, excluding the mouth, than cannot be safely removed |
1;2
|
1=Yes; 2=No
|
|
|
crest_exc10 |
Integer |
|
Recommended |
Require a benzodiasepine with a dose > lorazepam 2mg/day or equivalent or any anticonvulsant |
1;2
|
1=Yes; 2=No
|
|
|
crest_exc11 |
Integer |
|
Recommended |
Are unable to communicate in English fluently enough to complete the neuropsychological tests |
1;2
|
1=Yes; 2=No
|
|
|
crest_exc12 |
Integer |
|
Recommended |
Have a non-correctable clinically significant sensory impairment |
1;2
|
1=Yes; 2=No
|
|
|
crest_inc1 |
Integer |
|
Recommended |
Are in patients or outpatients |
1;2
|
1=Yes; 2=No
|
|
|
crest_inc2 |
Integer |
|
Recommended |
Are voluntary and competent to consent to treatment and research procedures according to ECT/MST attending psychiatrist |
1;2
|
1=Yes; 2=No
|
|
|
crest_inc3 |
Integer |
|
Recommended |
Have a MINI International Neuropsychiatric diagnosis, Version 6 (MINI-6.0) diagnosis of non-psychotic MDD |
1;2
|
1=Yes; 2=No
|
|
|
crest_inc4 |
Integer |
|
Recommended |
Are 18 years of age or older |
1;2
|
1=Yes; 2=No
|
|
|
crest_inc5 |
Integer |
|
Recommended |
Have a baseline HRSD-24 score = 21 |
1;2
|
1=Yes; 2=No
|
|
|
crest_inc6 |
Integer |
|
Recommended |
Are considered to be appropriate to receive convulsive therapy s assessed by an ECT attending psychiatrist and a consultant anaesthesiologist |
1;2
|
1=Yes; 2=No
|
|
|
crest_inc7 |
Integer |
|
Recommended |
Are agreeable to keeping their current antidepressant treatment constant during the intervention |
1;2
|
1=Yes; 2=No
|
|
|
incl_excl_contra_mri1 |
Integer |
|
Recommended |
Contraindications to MRI of the brain (such as metal in the head) |
0;1
|
0= No; 1= Yes
|
|
|
incl_excl_medchng |
Integer |
|
Recommended |
Medication change within the past month. |
0;1
|
0= No; 1= Yes
|
|
|
incl_excl_who |
String |
25
|
Recommended |
Who completed the inclusion/exclusion checklist? |
|
|
|
|
incl_excl_age1 |
Integer |
|
Recommended |
Age 10-14 years old |
0;1
|
0= No; 1= Yes
|
|
|
incl_excl_ic |
Integer |
|
Recommended |
Informed consent from a parent and assent from the child |
0;1
|
0= No; 1= Yes
|
|
|
incl_excl_disability1 |
Integer |
|
Recommended |
Intellectual delay/disability |
0;1
|
0= No; 1= Yes
|
|
|
incl_excl_asd |
Integer |
|
Recommended |
Autism (DSM-IV-TR) |
0;1
|
0= No; 1= Yes
|
|
|
incl_excl_psychosis |
Integer |
|
Recommended |
Psychosis |
0;1
|
0= No; 1= Yes
|
|
|
incl_excl_mania |
Integer |
|
Recommended |
Current major depression or bipolar disorder |
0;1
|
0= No; 1= Yes
|
|
|
incl_excl_depend |
Integer |
|
Recommended |
Substance dependence or current substance abuse |
0;1
|
0= No; 1= Yes
|
|
|
il23_excl2_mre |
Float |
|
Recommended |
Magnetic resonance elastography (MRE) |
|
kPa
|
|
|
il23_excl2_vcte |
Float |
|
Recommended |
Vibration Controlled Transient Elastography (VCTE) |
|
kPa
|
|
|
il23_excl2_fib4 |
Float |
|
Recommended |
Fibrosis-4 score (FIB-4) |
|
|
|
|
il23_excl3 |
Integer |
|
Recommended |
Co-infection with human immunodeficiency virus (HIV) |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl4 |
Integer |
|
Recommended |
History or evidence of positive Urine Drug Screen (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) except THC and legal prescription medications. |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl5 |
Integer |
|
Recommended |
Any active malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas) or any other malignancy diagnosed within the last five years |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl6 |
Integer |
|
Recommended |
History or evidence of active tuberculosis |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl7 |
Integer |
|
Recommended |
Positive Quantiferon test |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl8 |
Integer |
|
Recommended |
Significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure, serious psychiatric disease, that, in the opinion of the Investigator would preclude the patient from participating in and completing the study |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl9 |
Integer |
|
Recommended |
Patients requiring the use of vasopressors or inotropic support |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl10 |
Integer |
|
Recommended |
Any patient that has received any investigational drug within 30 days of dosing or who is scheduled to receive another investigational drug at any time during the study |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl11 |
Integer |
|
Recommended |
Patients who are taking drug products that are primarily the substrates of CYP2C8, such as chloroquine, paclitaxel, rosiglitazone, repaglinide |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl12 |
Integer |
|
Recommended |
If female, known pregnancy, or has a positive serum pregnancy test, or is lactating/breastfeeding |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl13 |
Integer |
|
Recommended |
Serum creatinine greater than 1.5 mg/dL |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl13_crea |
Float |
|
Recommended |
Serum creatinine |
|
mg/dL
|
|
|
il23_excl14 |
Integer |
|
Recommended |
Patients who have had organ transplantation (such as liver, kidney, lung, heart, bone marrow, or stem cell etc.), other than cornea transplant |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl15 |
Integer |
|
Recommended |
Presence of cirrhosis on imaging or any of following lab parameters: Albumin less than 3.7 gm/dl, Direct bilirubin greater than 0.5 mg/dl unless due to Gilbert''s syndrome, Platelets less than 140K, INR greater than 1.3 |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl15_alb |
Float |
|
Recommended |
Albumin |
|
g/dL
|
|
|
il23_excl15_dbili |
Float |
|
Recommended |
Direct Bili |
|
mg/dL
|
|
|
il23_excl15_plt |
Float |
|
Recommended |
Platelets |
|
|
|
|
il23_excl1b |
Integer |
|
Recommended |
Wilson disease (ceruloplasmin levels less than 10 mcg/L) |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl15_inr |
Float |
|
Recommended |
Prothrombin Time (INR) |
|
|
|
|
il23_excl16 |
Integer |
|
Recommended |
Presence of any features of portal hypertension such as ascites, history of ascites or varices, or encephalopathy |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl17 |
Integer |
|
Recommended |
Previous use of guselkumab ( or another IL-23 inhibitors) or hypersensitivity to guselkumab |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl18 |
Integer |
|
Recommended |
Previous history of skin cancers in the last 1 year |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl19 |
Integer |
|
Recommended |
Previous history of breast or prostate cancer or any cancer within the last 5 years |
0;1
|
0=No; 1=Yes
|
|
|
il23_incl2 |
Integer |
|
Recommended |
At least 21 years of age and BMI between 20 and 45 kg/m2 |
0;1
|
0=No; 1=Yes
|
|
|
il23_incl3 |
Integer |
|
Recommended |
Moderate alcohol use disorder (AUD) as defined by AASLD Practice Guidance to have 4 or more symptoms out of 11 |
0;1
|
0=No; 1=Yes
|
|
|
il23_incl3_all1 |
Integer |
|
Recommended |
List all inclusion criteria that apply: Alcohol is often taken in larger amounts and/or over a longer period that intended |
0;1
|
0=No; 1=Yes
|
|
|
il23_incl3_all2 |
Integer |
|
Recommended |
List all inclusion criteria that apply: Persistent attempts or one or more unsuccesful efforts made to cut down or control alcohol use |
0;1
|
0=No; 1=Yes
|
|
|
il23_incl3_all3 |
Integer |
|
Recommended |
List all inclusion criteria that apply: A great deal of time is spent in activities necessary to obtain alcohol, use alcohol, or recover from effects |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl1c |
Integer |
|
Recommended |
Vascular liver disease |
0;1
|
0=No; 1=Yes
|
|
|
il23_incl3_all4 |
Integer |
|
Recommended |
List all inclusion criteria that apply: Craving or strong desire or urge to use alcohol |
0;1
|
0=No; 1=Yes
|
|
|
il23_incl3_all5 |
Integer |
|
Recommended |
List all inclusion criteria that apply: Recurrent alcohol use resulting in a failure to fulfill major role obligations at work, school, or home |
0;1
|
0=No; 1=Yes
|
|
|
il23_incl3_all6 |
Integer |
|
Recommended |
List all inclusion criteria that apply: Continued alcohol use despite having persistent or recurrent social or interpersonal problem caused or exacerbated by the effects of the alcohol |
0;1
|
0=No; 1=Yes
|
|
|
il23_incl3_all7 |
Integer |
|
Recommended |
List all inclusion criteria that apply: Important social, occupational or recreational activities given up or reduced because of alcohol use |
0;1
|
0=No; 1=Yes
|
|
|
il23_incl3_all8 |
Integer |
|
Recommended |
List all inclusion criteria that apply: Recurrent alcohol use in situations in which it is physically hazardous |
0;1
|
0=No; 1=Yes
|
|
|
il23_incl3_all9 |
Integer |
|
Recommended |
List all inclusion criteria that apply: Alcohol use is continued despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the alcohol |
0;1
|
0=No; 1=Yes
|
|
|
il23_incl3_all10 |
Integer |
|
Recommended |
List all inclusion criteria that apply: Tolerance, as defined by either a) Markedly increased amounts of the alcohol in order to achieve intoxication or desired effect or b) Markedly diminished effect with continued use of the same amount |
0;1
|
0=No; 1=Yes
|
|
|
il23_incl3_all13 |
Integer |
|
Recommended |
List all inclusion criteria that apply: Withdrawal, as manifested by either a) The characteristic alcohol withdrawal syndrome or b) Alcohol (or a closely related substance) is taken to relieve or avoid withdrawal symptoms |
0;1
|
0=No; 1=Yes
|
|
|
il23_incl4 |
Integer |
|
Recommended |
Evidence of end-organ damage to the liver as defined by: MRI-PDFF greater than or equal to 8% suggestive of significant hepatic accumulation of triglyceride. If MRI-PDFF is not available, then CAP greater than or equal to 300dB/m |
0;1
|
0=No; 1=Yes
|
|
|
il23_incl4_pdff |
Float |
|
Recommended |
MRI-PDFF |
|
kPa
|
|
|
il23_excl1d |
Integer |
|
Recommended |
Drug induced liver disease |
0;1
|
0=No; 1=Yes
|
|
|
il23_incl4_cap |
Float |
|
Recommended |
CAP score |
|
kPa
|
|
|
il23_incl5 |
Integer |
|
Recommended |
Consumed alcohol within 12 weeks of entry into study, and AST and ALT less than 200 u/L |
0;1
|
0=No; 1=Yes
|
|
|
il23_incl5_alt |
Float |
|
Recommended |
Alanine aminotransferase (ALT) |
|
u/L
|
|
|
il23_incl5_ast |
Float |
|
Recommended |
Aspartate aminotransferase (AST) |
|
u/L
|
|
|
il23_incl6 |
Integer |
|
Recommended |
No evidence of active infection as determined by investigator |
0;1
|
0=No; 1=Yes
|
|
|
il23_incl7 |
Integer |
|
Recommended |
Women of child-bearing potential (defined as females who are not surgically sterile or who are not over the age of 52 and amenorrheic for at least 12 months) must utilize appropriate birth control throughout the study duration |
0;1
|
0=No; 1=Yes
|
|
|
il23_incl8 |
Integer |
|
Recommended |
Male patients must agree to use a medically acceptable method of contraception/birth control throughout the study duration |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl1e |
Integer |
|
Recommended |
Surface antigen positive hepatitis B (HBsAg positive) |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl1f |
Integer |
|
Recommended |
Acute hepatitis A |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl1g |
Integer |
|
Recommended |
Acute HCV or chronic hepatitis C with a history of decompensated cirrhosis |
0;1
|
0=No; 1=Yes
|
|
|
il23_excl2 |
Integer |
|
Recommended |
Non-invasive criteria to exclude cirrhosis: Imaging evidence of varices, splenomegaly, ascites, or shrunken cirrhotic liver |
0;1
|
0=No; 1=Yes
|
|
|
chrcrit_excl1 |
Integer |
|
Recommended |
Antipsychotic medication exposure equivalent to a total lifetime haloperidol dose of >50 mg (see Table 1.0 for haloperidol equivalents), estimated based on available information (e.g., medical file documentation, participants and family report)? |
0;1;-900;-300
|
0=No; 1=Yes; -900=Missing; -300=N/A
|
|
|
chrcrit_excl9 |
Integer |
|
Recommended |
Current antipsychotic medication at time of screening assessment, based on available information (e.g., medical file documentation, participants and family report) |
0;1;-900;-300
|
0=No; 1=Yes; -900=Missing; -300=N/A
|
|
|
chrcrit_excl2 |
Integer |
|
Recommended |
Documented history of intellectual disability |
0;1;-900;-300
|
0=No; 1=Yes; -900=Missing; -300=N/A
|
|
|
chrcrit_excl3 |
Integer |
|
Recommended |
Past or current clinically relevant central nervous system disorder. When necessary, Research Assistants will consult with study team investigators (including medical personnel) to determine if the central nervous system disorder is deemed to be clinically relevant |
0;1;-900;-300
|
0=No; 1=Yes; -900=Missing; -300=N/A
|
|
|
chrcrit_excl4 |
Integer |
|
Recommended |
Traumatic brain injury that is rated as 7 or above on the Traumatic Brain Injury screening instrument |
0;1;-900;-300
|
0=No; 1=Yes; -900=Missing; -300=N/A
|
|
|
chrcrit_excl5 |
Integer |
|
Recommended |
Current or past treated or untreated psychotic episode, as determined using the PSYCHS |
0;1;-900;-300
|
0=No; 1=Yes; -900=Missing; -300=N/A
|
|
|
chrcrit_excl6 |
Integer |
|
Recommended |
Meets criteria for any Cluster A personality disorder diagnosis |
0;1;-900;-300
|
0=No; 1=Yes; -900=Missing; -300=N/A
|
|
|
chrcrit_excl7 |
Integer |
|
Recommended |
Receiving any current treatment with psychotropic medication |
0;1;-900;-300; 888
|
0=No; 1=Yes; -900=Missing; -300=N/A; 888 = Not assessed - patient was ineligible
|
|
|
chrcrit_excl8 |
Integer |
|
Recommended |
Has a family history (in first-degree relatives) of psychotic spectrum disorders |
0;1;-900;-300
|
0=No; 1=Yes; -900=Missing; -300=N/A
|
|
|
chrcrit_included |
Integer |
|
Recommended |
Is the participant included or excluded? |
0;1;-900;-300
|
0=Excluded; 1=Included; -900=Missing; -300=N/A
|
|
|
chrcrit_excluded |
Integer |
|
Recommended |
Is the participant included or excluded? |
0;1;-900;-300
|
0=Excluded; 1=Included; -900=Missing; -300=N/A
|
|
|
ampscz_missing |
Integer |
|
Recommended |
Please click if this form is missing all of its data |
0;1
|
0 = Not clicked; 1 = Clicked
|
chrcrit_missing |
|
ampscz_missing_spec |
Integer |
|
Recommended |
Please specify the reason for missing data on this form |
0::6
|
0 = Evaluation not necessary because the screening visit was less than 21 days from baseline visit; 1 = Measure refusal (no reason provided); 2 = No show; 3 = Research assistant forgot; 4 = Uncontrollable circumstance; 5 = Participant dropped out; 6 = Evaluation not necessary because the screening visit was less than 21 days from baseline visit
|
chrcrit_missing_spec |
|
chrcrit_part |
Integer |
|
Recommended |
Inclusion/Exclusion Criteria is being filled out for a |
1;2;-900;-300
|
1=CHR Participant; 2=Healthy Control Participant; -900=Missing; -300=N/A
|
|
|
chrcrit_inc1 |
Integer |
|
Recommended |
Individuals between 12 and 30 years old |
0;1;-900;-300
|
0=No; 1=Yes; -900=Missing; -300=N/A
|
|
|
chrcrit_inc2 |
Integer |
|
Recommended |
Understand and sign an informed consent (or assent for minors) document |
0;1;-900;-300
|
0=No; 1=Yes; -900=Missing; -300=N/A
|
|
|
chrcrit_inc3 |
Integer |
|
Recommended |
Meet diagnostic criteria for CHR from the Positive Symptoms and Diagnostic Criteria for the CAARMS Harmonized with the SIPS (PSYCHS) |
0;1;-900;-300
|
0=No; 1=Yes; -900=Missing; -300=N/A
|
|
|
pitolisant_1 |
Integer |
|
Recommended |
Is 21 to 55 years of age. |
0;1
|
0=No; 1= Yes
|
|
|
pitolisant_2 |
Integer |
|
Recommended |
Can provide proof of age with state-issued or federal picture ID. |
0;1
|
0=No; 1= Yes
|
|
|
pitolisant_3 |
Integer |
|
Recommended |
Exceeds safe weekly drinking limits ( more than 14 drinks for women or more than 21 drinks for men per week). |
0;1
|
0=No; 1= Yes
|
|
|
pitolisant_4 |
Integer |
|
Recommended |
Reports at least one episode of binge drinking (more than 3 for women, more than 4 for men) in the 28 days prior to consent. |
0;1
|
0=No; 1= Yes
|
|
|
pitolisant_5 |
Integer |
|
Recommended |
Meets DSM-5 criteria for mild alcohol use disorder or greater severity. |
0;1
|
0=No; 1= Yes
|
|
|
pitolisant_13 |
Integer |
|
Recommended |
Current risk of suicidality (MINI suicidality score greater than 8 (low risk) or Yes to the ideation question 4 of the C-SSRS). |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_14 |
Integer |
|
Recommended |
Clinical Institute Withdrawal Assessment at greater than or equal to 10. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_15 |
Integer |
|
Recommended |
If female, pregnant, nursing, or has plans to become pregnant. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_16 |
Integer |
|
Recommended |
If female, does not agree to use an accepted form of birth control. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_17 |
Integer |
|
Recommended |
Has a medical contraindication to the use of pitolisant. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_18 |
Integer |
|
Recommended |
Has diagnosed medical or mental condition for which further alcohol exposure at the planned dose range would be contraindicated. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_19 |
Integer |
|
Recommended |
Have history of any clinically significant renal or hepatic disease. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_20 |
Integer |
|
Recommended |
Has a history of cardiac arrhythmias or who for other reasons are at risk for developing Torsade de Pointes including those with bradycardia, hypokalemia, and congenital QT interval prolongation. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_21 |
Integer |
|
Recommended |
Has a history of dementia. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_22 |
Integer |
|
Recommended |
BMI is less than 18 or greater than 40. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_23 |
Integer |
|
Recommended |
Impaired renal function (GFR less than 80 mL/min). |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_24 |
Integer |
|
Recommended |
Child Pugh Score equal to or greater than Class B. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_25 |
Integer |
|
Recommended |
Taking a medication which contains a QTc prolongation agent. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_26 |
Integer |
|
Recommended |
Has a clinically significant ECG or abnormal ECG heart rate (less than 45 or greater than 100 bpm) or QTc interval corrected for heart rate using the Fridericia formula (QTcF) greater than 450 msec. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_27 |
Integer |
|
Recommended |
Taking a medication which will significantly alter drug metabolism (e.g., strong CYP2D6 inhibitors, strong CYP3A4 inducers, or H1 receptor antagonists that cross the blood barrier (e.g. diphenhydramine or meclizine)). |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_28 |
Integer |
|
Recommended |
Taking a medication that is a sensitive CYP3A4 substrate. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_29 |
Integer |
|
Recommended |
Known to be a poor CYP2D6 metabolizer. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_30 |
Integer |
|
Recommended |
Has known hypersensitivity to pitolisant and any of its components, riboflavin, and/or lactose. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_31 |
Integer |
|
Recommended |
Has COPD, history of solid organ transplant, sickle cell disease, severe heart disease or other health condition for which exposure to COVID19 represents an unreasonable risk as determined by the study staff physician using accepted COVID19 guidance (e.g. Centers for Disease Control, etc.). |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_32 |
Integer |
|
Recommended |
Subject is eligible for randomization? |
0;1
|
0=No; 1= Yes
|
|
|
pitolisant_6 |
Integer |
|
Recommended |
Does not have a smartphone to complete medication exposure period study assessments. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_7 |
Integer |
|
Recommended |
Seeking treatment for alcohol problems. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_8 |
Integer |
|
Recommended |
Has received alcohol counseling or other non-pharmacologic intervention to treat AUD (Alcohol Use Disorder) in the past 90 days. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_9 |
Integer |
|
Recommended |
Has taken medications that are used to treat AUD in the past 90 days. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_10 |
Integer |
|
Recommended |
Unable to comfortably abstain from nicotine for a period of 8 hours. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_11 |
Integer |
|
Recommended |
Has urine toxicology results positive for cocaine, opioids, amphetamines, buprenorphine, methadone, methamphetamines, oxycontin, barbiturates, or benzodiazepines. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
pitolisant_12 |
Integer |
|
Recommended |
DSM5 diagnosis of current major depression, bipolar disorder, schizophrenia, bulimia/anorexia, insomnia disorder or a substance use disorder other than alcohol, nicotine, marijuana or caffeine. |
0;1;99
|
0=No; 1= Yes; 99= N/A
|
|
|
discuss_expln_rvw |
Integer |
|
Recommended |
Discussed, explained and reviewed the consent form with participant. |
1;2
|
1 = Yes; 2 = No
|
|
|
pt_time_rvw |
Integer |
|
Recommended |
Participant was given time to review the consent form and to discuss participation in this study with family members/others. |
1;2
|
1 = Yes; 2 = No
|
|
|
placed_rsch_rcrd |
Integer |
|
Recommended |
The original signed and dated consent form was placed in the research record. |
1;2
|
1 = Yes; 2 = No
|
|
|
pt_qstn_ansewred |
Integer |
|
Recommended |
All of the participant's questions were answered/concerns addressed. |
1;2
|
1 = Yes; 2 = No
|
|
|
question_docmnt |
String |
255
|
Recommended |
Documentation of participant questions: |
|
|
|
|
consent_date |
Date |
|
Recommended |
Date participant signed consent: |
|
MM/DD/YYYY
|
|
|
consent_version |
Integer |
|
Recommended |
Consent Version #: |
|
|
|
|
consent_vrsn_date |
Date |
|
Recommended |
Consent Version Date: |
|
MM/DD/YYYY
|
|
|
first_proc_date |
Date |
|
Recommended |
Date of First trial-related procedure: |
|
MM/DD/YYYY
|
|
|
copy_offered_pt |
Integer |
|
Recommended |
Was a copy of the consent offered to the participant? |
1;2
|
1 = Yes; 2 = No
|
|
|
pt_comprehend |
Integer |
|
Recommended |
Did the participant demonstrate comprehension of the informed consent materials? |
1;2
|
1 = Yes; 2 = No
|
|
|
pt_fluent_eng |
Integer |
|
Recommended |
Did the participant demonstrate fluency in the English language? |
1;2
|
1 = Yes; 2 = No
|
|
|
enrollstatus08 |
Integer |
|
Recommended |
Reason for exclusion: Lack of PTSD symptoms |
0;1
|
0=Unchecked; 1=Checked
|
|
|
enrollstatus09 |
Integer |
|
Recommended |
Reason for exclusion: Questionable validity/motivation |
0;1
|
0=Unchecked; 1=Checked
|
|
|
enrollstatus10 |
Integer |
|
Recommended |
Reason for exclusion: Referred for further treatment |
0;1
|
0=Unchecked; 1=Checked
|
|
|
enrollstatus11 |
Integer |
|
Recommended |
Reason for exclusion: Scheduling Conflicts |
0;1
|
0=Unchecked; 1=Checked
|
|
|
enrollstatus12 |
Integer |
|
Recommended |
Reason for exclusion: Recent concussion |
0;1
|
0=Unchecked; 1=Checked
|
|
|
enrollstatus13 |
Integer |
|
Recommended |
Reason for exclusion: Needs more intensive treatment |
0;1
|
0=Unchecked; 1=Checked
|
|
|
enrollstatus14 |
Integer |
|
Recommended |
Reason for exclusion: Other |
0;1
|
0=Unchecked; 1=Checked
|
|
|
enrollstatus15 |
String |
500
|
Recommended |
Reason for exclusion: Please explain |
|
|
|
|
enrollstatus01 |
Integer |
|
Recommended |
What is the participant''s enrollment status after baseline appointment? |
1::3
|
1=Enrolled; 2=Ineligible; 3=Withdrew; 4=Lost to follow-up
|
|
|
enrollstatus02 |
Integer |
|
Recommended |
Reason for exclusion: Active eating disorder |
0;1
|
0=Unchecked; 1=Checked
|
|
|
enrollstatus03 |
Integer |
|
Recommended |
Reason for exclusion: Positive Clinical Institute Withdrawal Assessment(CIWA) |
0;1
|
0=Unchecked; 1=Checked
|
|
|
enrollstatus04 |
Integer |
|
Recommended |
Reason for exclusion: Mania |
0;1
|
0=Unchecked; 1=Checked
|
|
|
enrollstatus05 |
Integer |
|
Recommended |
Reason for exclusion: Psychosis |
0;1
|
0=Unchecked; 1=Checked
|
|
|
enrollstatus06 |
Integer |
|
Recommended |
Reason for exclusion: Suicidal Ideation(SI) |
0;1
|
0=Unchecked; 1=Checked
|
|
|
enrollstatus07 |
Integer |
|
Recommended |
Reason for exclusion: Lost to follow-up |
0;1
|
0=Unchecked; 1=Checked
|
|
|
exclusion_crit3 |
Integer |
|
Recommended |
Does the subject have an overall score of 14 or higher on the Beck Depression Inventory? |
0;1; 888
|
0=No; 1=Yes; 888 = Not assessed - patient was ineligible
|
|
|
exclusion_crit4 |
Integer |
|
Recommended |
Does the subject have current suicidal ideation with intent/plan (answered 3 or 4 to question 9 of the Beck Depression Inventory) |
0;1; 888
|
0=No; 1=Yes; 888 = Not assessed - patient was ineligible
|
|
|
exclusion_crit5 |
Integer |
|
Recommended |
Has the subject ever suffered a head or brain injury? |
0;1; 888
|
0=No; 1=Yes; 888 = Not assessed - patient was ineligible
|
|
|
exclusion_crit6 |
Integer |
|
Recommended |
Does the subject have any current psychiatric illness? |
0;1; 888
|
0=No; 1=Yes; 888 = Not assessed - patient was ineligible
|
|
|
exclusion_crit7 |
Integer |
|
Recommended |
Does the subject have any current or previous neurological illness? |
0;1; 888
|
0=No; 1=Yes; 888 = Not assessed - patient was ineligible
|
|
|
exclusion_crit8 |
Integer |
|
Recommended |
Does the subject meet criteria for substance abuse? |
0;1; 888
|
0=No; 1=Yes; 888 = Not assessed - patient was ineligible
|
|
|
exclusion_crit9 |
Integer |
|
Recommended |
Does the subject suffer from frequent or severe headaches? |
0;1; 888
|
0=No; 1=Yes; 888 = Not assessed - patient was ineligible
|
|
|
exclusion_crit12 |
Integer |
|
Recommended |
If female, is the subject currently pregnant, planning to become pregnant in the next month, or breastfeeding? (to be confirmed by urine pregnancy screen right before the MRI scan). |
0;1; 888
|
0=No; 1=Yes; 888 = Not assessed - patient was ineligible
|
|
|
fspgod |
String |
70
|
Recommended |
Subject's gender OTHER describe |
|
|
|
|
vis_type |
Integer |
|
Recommended |
Visit type |
0::2
|
1=Phone/remote; 0=doctor's office/In person; 2=No, not phone interview
|
|
|
pu_suicd6mo |
Integer |
|
Recommended |
Suicide attempts during past 6 months? |
0;1; 888
|
0=No; 1=Yes; 888 = Not assessed - patient was ineligible
|
|
|
inclusion_crit1 |
Integer |
|
Recommended |
Did the subject provide a written signed informed consent form/forms (IRB/IEC specific) prior to the initiation of any protocol required procedures? |
0;1; 888
|
0=No; 1=Yes; 888 = Not assessed - patient was ineligible
|
|
|
inclusion_crit2 |
Integer |
|
Recommended |
Is the subject between the ages of 18-68 inclusive? |
0;1; 888
|
0=No; 1=Yes; 888 = Not assessed - patient was ineligible
|
|
|
inclusion_crit3 |
Integer |
|
Recommended |
Does the subject have a high school degree or equivalent? |
0;1; 888
|
0=No; 1=Yes; 888 = Not assessed - patient was ineligible
|
|
|
inclusion_crit4 |
Integer |
|
Recommended |
Can the subject read and speak English? |
0;1; 888
|
0=No; 1=Yes; 888 = Not assessed - patient was ineligible
|
|
|
exclusion_crit06 |
Integer |
|
Recommended |
Family has participated in a previous course of family-focused therapy (FFT) |
0;1
|
0=No; 1=Yes
|
|
|
exclusion_crit07 |
Integer |
|
Recommended |
Currently enrolled in family therapy and are unwilling to postpone this treatment |
0;1
|
0=No; 1=Yes
|
|
|
exclusion_crit08 |
Integer |
|
Recommended |
Sexual or physical abuse by a family member has occurred recently and/or is unresolved |
0;1
|
0=No; 1=Yes
|
|
|
computerdiag |
Integer |
|
Recommended |
Computer Diagnosis/Meet Criteria |
0;1
|
0=No; 1=Yes
|
|
|
pidiag |
Integer |
|
Recommended |
Principal Investigator''s overall Diagnosis |
0;1
|
0=No; 1=Yes
|
|
|
pidiagdate |
Date |
|
Recommended |
Principal Investigator''s Diagnosis Date |
|
MM/DD/YYYY
|
|
|
inclusion_crit01 |
Integer |
|
Recommended |
Youth and participant caregivers are English-speaking |
0;1
|
0=No; 1=Yes
|
|
|
inclusion_crit02 |
Integer |
|
Recommended |
Youth is between age 13 years 0 months and 25 years 11 months |
0;1
|
0=No; 1=Yes
|
|
|
inclusion_crit03 |
Integer |
|
Recommended |
At least one parent or guardian who spends more than 4 hours per week with youth is willing to participate in family treatment and research sessions |
0;1
|
0=No; 1=Yes
|
|
|
inclusion_crit04 |
Integer |
|
Recommended |
Youth meets criteria for clinical high-risk (CHR) criteria for psychosis (APS or BIPS) |
0;1
|
0=No; 1=Yes
|
|
|
exclusion_crit03 |
Integer |
|
Recommended |
Active in individual therapy and not willing to reduce sessions to once per month during 6 months of UPLIFT therapy |
0;1
|
0=No; 1=Yes
|
|
|
exclusion_crit04 |
Integer |
|
Recommended |
Past or current history of clinically significant central nervous system (CNS) disorder that may significantly contribute to clinical high-risk (CHR) symptoms or confound clinical high-risk (CHR) assessment or diagnosis |
0;1
|
0=No; 1=Yes
|
|
|
exclusion_crit05 |
Integer |
|
Recommended |
Severe substance or alcohol use disorder in the past 6 months and/or substance use confounds diagnostic assessment for clinical high-risk (CHR) |
0;1
|
0=No; 1=Yes
|
|