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Clinical Trials: Inclusion/Exclusion Criteria

iec

01

Clinical Trials: Inclusion/Exclusion Criteria

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Element NameData TypeSizeRequiredDescriptionValue RangeNotesAliases
subjectkeyGUIDRequiredThe NDAR Global Unique Identifier (GUID) for research subjectNDAR*guid
src_subject_idString20RequiredSubject ID how it's defined in lab/projectSUBJECT, bid, patid, pid, randid, record_id, subject_id, subjectid
interview_dateDateRequiredDate on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYYRequired fieldIECDate, date_consent, elg_ct_doa, elg_p_doa, iedt, intvdate, visit_date
interview_ageIntegerRequiredAge in months at the time of the interview/test/sampling/imaging.0 :: 1260Age 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
genderString20RequiredSex of the subjectM;FM = Male; F = Femaleiec13a, rdm13, sex
aescodeIntegerRecommendedStaff code number of person completing this formIECCODE
visitString50RecommendedVisit nameCharacter description of each type of visitinex_interval, interval, timept, visit_name, vtypscrn
iec1IntegerRecommendedHas the patient demonstrated adequate decisional capacity to make a choice about participating in this research study AND provided informed consent to participate?0;10=No; 1= Yeselg_ct_can_consent, elg_p_can_consent, ieca1b, ieca3_1, incic, rdm1
iec2IntegerRecommendedIs the patient older than 18 years of age?0;10=No; 1= Yesagege18, ieca3
iec3IntegerRecommendedDoes the patient have a diagnosis of schizophrenia or schizoaffective disorder (DSM-IV-TR), confirmed by SCID?0;10=No; 1= Yesieca2, ieca4_1, rdm3
iec4IntegerRecommendedAre the patient's PANSS scores for Hallucinatory Behavior (Item P3), Unusual Thought Content (Item G9) and Conceptual Disorganization (Item P2) each ? 5?0;10=No; 1= Yes
iec5IntegerRecommendedIn the judgment of the Investigator, will the patient be able to complete the baseline MATRICS Consensus Cognitive Battery (MCCB) validly?0;10=No; 1= Yes
iec6IntegerRecommendedDoes the patient have a raw score >=37 on the WRAT-3?0;10=No; 1= Yes
iec7IntegerRecommendedDid the patient learn English before age 12?0;10=No; 1= Yes
iec8IntegerRecommendedIs the patient able to state specific goals relevant to the intervention that they would like to achieve?0;10=No; 1= Yes
iec9IntegerRecommendedIn the judgment of the Investigator, will the patient be able to participate in the computerized intervention?0;10=No; 1= Yes
iec10IntegerRecommendedHas the patient had a psychiatric hospitalization in the 8 weeks prior to randomization?0;10=No; 1= Yes
iec11IntegerRecommendedHas the patient had an adjustment to their antipsychotic medication in the 4 weeks prior to randomization?0;10=No; 1= Yes
iec12IntegerRecommendedIs the patient currently taking an anticholinergic medication?0;10=No; 1= Yes
iec13IntegerRecommendedDoes the patient have a diagnosis of alcohol or substance abuse (other than nicotine) within the past month, confirmed by SCID?0;10=No; 1= Yesdsm, ieca18
iec14IntegerRecommendedDoes the patient have a diagnosis of alcohol or substance dependence (other than nicotine) within the past 6 months, confirmed by SCID?0;10=No; 1= Yes
iec15IntegerRecommendedDoes 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;10=No; 1= Yesdb_exc6, ieca12
iec16IntegerRecommendedEligibility status1::31=Eligible; 2= Ineligible; 3=Pendingiea003a, ieca13, ieca25
iecsigIntegerRecommendedInvestigator signature on form.0;10=No; 1= Yes
daysrzIntegerRecommendeddays since randomizationiec0b, rdm0b, studyday
certcodeIntegerRecommendedstepbd certification code
ptconIntegerRecommendedPatient consented
0;1
0=No; 1=Yesconsent, consent1, db_inc8
dsmcritIntegerRecommendedMeets criteria for Bipolar Disorder, Type I or II0;1;-70=No; 1=Yes; -7=Refused
conceiveIntegerRecommendedPatient must be of childbearing potential and wanting to conceive0;1;-70=No; 1=Yes; -7=Refused
agrtobcIntegerRecommendedPatient agrees to use adequate birth control until week 14 of the study or as otherwise advised by the treating psychiatrist0::2;-70=No; 1=Yes; -7=Refused; 2=NAieca10_1
cmfrecovIntegerRecommendedCMF recovered status0;1;-70=No; 1=Yes; -7=Refused
cmfstatIntegerRecommendedCMF recovery time1;2;-71=Recovered > 1 year; 2=Recovered<=1 year; -7=Refused
subabuseIntegerRecommendedcurr substance abuse or depend0;1;-70=No; 1=Yes; -7=Refused
unmedillIntegerRecommendedUnstable medical illness0;1;-70=No; 1=Yes; -7=Refusedelg_ct_acute_illness, elg_p_acute_illness, excs16, inex_exc1
othstudyIntegerRecommendedPatient participating in Non-STEP-BD study0;1;-70=No; 1=Yes; -7=Refused
pregnantIntegerRecommendedPatient is currently pregnant0::2;-7; 9990=No; 1=Yes;2=DK;-7= Refused; 999=Legimately skippedelg_ct_pregnancy, elg_p_pregnancy, iea002o, iec14a, ieca11, inex_exc8, preg, rdm14, rdm14a
psychsymIntegerRecommendedPsychotic symptoms0;1;-7; -90=No; 1=Yes; -7=Refused; -9 =unknown
psychmedIntegerRecommendedPatientt is taking > 5 psychotropic meds0;1;-70=No; 1=Yes; -7=Refused
takenom3IntegerRecommendedPatient has taken Omega-3 fatty acids (fish oil, flax seed oil, etc.) in the past 4 weeks0;1;-70=No; 1=Yes; -7=Refused
rzrcpprgIntegerRecommendedDid you ask the patient if she would like to be randomized to the Pregnancy RCP?0;1;-70=No; 1=Yes; -7=Refused
ccppIntegerRecommendedDid the patient agree to participate in Collaborative Care-Plus (CCP-P)?0;1;-70=No; 1=Yes; -7=Refused
ccppdayIntegerRecommendedCCP-P consent days from randomization
othrpartIntegerRecommendedDoes the patient have a family member, a spouse, or close friend who would be willing to take part in treatment?0;1;-70=No; 1=Yes; -7=Refused
siteString100RecommendedSiteStudy Siteinex_site_x, site_ga, site_id, site_uid, siteid
vital_collectIntegerRecommendedWas any data collected for this form?
0;1
1 = Yes; 0 = No
incexq1IntegerRecommendedInclusion Criteria: Diagnosis of ASD as defined by DSM-5, confirmed by clinical evaluation and supported by the Autism Diagnostic Observation Schedule (ADOS)0;1; -90=No; 1=Yes; -9=unknowniea001a
incexq2IntegerRecommendedInclusion Criteria: Age 18-35 years inclusive0;1; -90=No; 1=Yes; -9=unknowniea001b, iec2a, ieh001a, rdm2
incexq3IntegerRecommendedInclusion Criteria: IQ estimate of greater than or equal to 800;1;-9;-70=No; 1=Yes; -9=unknown; -9=unknown; -7=refusediea001c, ieh001b
incexq4IntegerRecommendedInclusion Criteria: Clinical Global Impression - Severity scale of 4 (moderate) or greater0;1; -90=No; 1=Yes; -9=unknowniea001d
incexq5IntegerRecommendedInclusion Criteria: Existing allowed concomitant medication treatment stable for the 8 weeks prior to study entry, and no anticipated changes0;1; -90=No; 1=Yes; -9=unknowniea001e
incexq6IntegerRecommendedInclusion Criteria: Capacity to provide informed consent as demonstrated by a score of greater than 14.5 on the UBACC0;1; -90=No; 1=Yes; -9=unknowniea001f
incexq7IntegerRecommendedInclusion Criteria: Ability to comply with all protocol procedures and assessments0;1; -90=No; 1=Yes; -9=unknowniea001g, ieh001c, incproc
incexq8IntegerRecommendedInclusion Criteria: Availability of an informant willing to provide information regarding subject behavior and health status0;1; -90=No; 1=Yes; -9=unknowniea001h
incexq9IntegerRecommendedInclusion Criteria: Evidence of EEG biomarker deficit as defined in section C4.30;1; -90=No; 1=Yes; -9=unknowniea001i
incexq10IntegerRecommendedExclusion Criteria: Evidence of current drug or alcohol abuse or dependence0;1; -90=No; 1=Yes; -9=unknowniea002a
incexq11IntegerRecommendedExclusion Criteria: History of current or prior drug or alcohol use or dependence in past 12 months0;1; -90=No; 1=Yes; -9=unknowniea002b, ieh002a
incexq12IntegerRecommendedExclusion Criteria: History of seizure disorder (except febrile seizures)0;1; -90=No; 1=Yes; -9=unknowniea002c, ieh002b, q13_6a
incexq13IntegerRecommendedExclusion Criteria: Clinically significant aggressive, disruptive, or suicidal behavior in the 3 months prior to study enrollment0;1; -90=No; 1=Yes; -9=unknownexsuicid, iea002d
incexq14IntegerRecommendedExclusion 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 events0;1; -90=No; 1=Yes; -9=unknowniea002e
incexq15IntegerRecommendedExclusion 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;-90=No; 1=Yes; -9=unknown; -7=refusediea002f, ieh002e
incexq16IntegerRecommendedExclusion Criteria: History of narrow-angle glaucoma0;1; -90=No; 1=Yes; -9=unknowniea002g
incexq17IntegerRecommendedExclusion Criteria: History of paradoxical reactions to benzodiazepines0;1; -90=No; 1=Yes; -9=unknowniea002h
incexq18IntegerRecommendedExclusion Criteria: Clinically significant deviation from the reference range in clinical laboratory test results at screening, as judged by the investigator0;1; -90=No; 1=Yes; -9=unknowniea002i, ieh002f
incexq19IntegerRecommendedExclusion Criteria: ALT or AST greater than the upper limit of the laboratory standard reference range at screening.0;1; -90=No; 1=Yes; -9=unknowniea002j
incexq20IntegerRecommendedExclusion Criteria: EKG abnormalities considered to be clinically significant as determined by the investigator and confirmed by an experienced cardiologist0;1; -90=No; 1=Yes; -9=unknowniea002k
incexq21IntegerRecommendedExclusion Criteria: Fredericia-corrected QT (QTcF) interval of >450 msec0;1; -90=No; 1=Yes; -9=unknowniea002l
incexq22IntegerRecommendedExclusion Criteria: Clinical judgment of the study physician of inability to perform the requirements of the study0;1; -90=No; 1=Yes; -9=unknowniea002m
incexq23IntegerRecommendedExclusion Criteria: For sexually active female and male subjects, refusal to agree to maintain a double-barrier birth control method during protocol participation0;1; -90=No; 1=Yes; -9=unknowniea002n
incexq24DateRecommendedIf yes, date of eligibilityiea003b, iec003b, ieh003b
incexq25IntegerRecommendedIf no, specify ineligibility1::8; -91=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=unknowniea003c, iec003c, ieh003c, scrflrs
comments_miscString4,000RecommendedMiscellaneous comments on study, interview, methodology relevant to this form dataelg_ct_notes, elg_p_notes
visitidIntegerRecommendedMetaTrial Visit IDSystem variable: unique code for each type of visit -use to merge files
fseqnoIntegerRecommendedSequence Number0::999The 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.
visdayIntegerRecommendedNumber of days from study baseline to date of visitdayraf, ieca0b, inex_visitdat_x
ieca1aIntegerRecommendedUBACC Score0::20
ieca4IntegerRecommendedDoes the treating clinician feel the patient is likely to benefit from treatment with study medication?0;11=yes; 0=no
ieca5IntegerRecommendedIs 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 abuse0;11=yes; 0=no
ieca6IntegerRecommendedIf child bearing potential, was serum pregnancy test negative? (code X if not applicable)0;11=yes; 0=no
ieca7IntegerRecommendedIs patient currently stable and doing well on antipsychotic regimen?0;11=yes; 0=noiec4a, ieca6a, rdm4
ieca8IntegerRecommendedIs 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;11=yes; 0=no
scrn10IntegerRecommended10. Does the patient have tardive dyskinesia0::40=No; 1=Yes;2=Current; 3=In partial remission; 4=Pastieca9
ieca10IntegerRecommendedDoes 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)?0;11=yes; 0=nodb_exc7, exother, iec20, ieca24, rdm20
version_formString100RecommendedForm usedform_name, vers
rdm24IntegerRecommendedDo you want to randomize this patient0;10=No; 1=Yes
site_pString5RecommendedPseudo Site: Pooled According To Size05;16;28;37;p1;p2;p3;p4;p5;p6
consentIntegerRecommendedConsent at screening0;10=No; 1=Yes;
selIntegerRecommendedEligible at screening0;10=No; 1=Yes;
selunIntegerRecommendedScreen Eligibility Unknown0;10=No; 1=Yes;
snelIntegerRecommendedIneligible at screening0;10=No; 1=Yes;
scrIntegerRecommendedScreened0;10=No; 1=Yes;
iec16bIntegerRecommendedIs 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;1;9990=No; 1=Yes; 999=Legitimately skippedincbirth, rdm16a
bmiFloatRecommendedbody mass index of subjectiec5a, rdm5
laba125String20RecommendedNhdliec10a, iec6a1, rdm10, rdm6
laba6IntegerRecommendedLdl Cholesterol (Mg/Dl)-9=Unknown; -1=Normaliec6a, rdm6a
laba3aIntegerRecommendedFasting Glucose (Mg/Dl)iec7a, rdm7
mdga10cIntegerRecommendedIs patient now on oral hypoglycemic agent0;11=Yes; 0=Noiec8a, rdm8
iec9aIntegerRecommendedIs the patient being treated with insulin? (Y/N) (NO is eligible)0;10=No; 1=Yesrdm9
rsptrig_noFloatRecommendedBlood value - Triglycerides (mg/dL)-9=Unknowniec11a, rdm11
iec12aIntegerRecommendedIs 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;10=No; 1=Yesrdm12
breastfdIntegerRecommendedcurrently breast feeding0;1;-7; 9990=No; 1=Yes;-7= Refused; 999=Legimately skippediec15a, rdm15a
iec16aIntegerRecommendedIs she a woman who can become pregnant? (Y/N) (NO is eligible) Note: Yes may be eligible if answer to Q16a is YES0;1;9990=No; 1=Yes; 999=Legitimately skippedrdm16
iec17IntegerRecommendedIs the patient, in the judgment of the investigator, at a high risk for suicide? (Y/N)0;10=No; 1=Yesrdm17
iec18IntegerRecommendedDoes 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;10=No; 1=Yesrdm18
iec19IntegerRecommendedDoes the patient have a history of HIV/AIDS? (NO to MHXA3 is eligible)0;10=No; 1=Yesrdm19
iec21IntegerRecommendedDoes 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;10=No; 1=Yesieca16, rdm21
iec22IntegerRecommendedHas the patient participated in a clinical trial with an investigational agent within the four weeks preceding baseline? (Y/N) (NO is eligible)0;10=No; 1=Yesrdm22
iec23IntegerRecommendedHave you collected all of the screening information necessary to determine eligibility for this patient?0;10=No; 1=Yesrdm23
raceString30RecommendedRace of study subjectAmerican Indian/Alaska Native; Asian; Hawaiian or Pacific Islander; Black or African American; White; More than one race; Unknown or not reportedrace1
session_idString20Recommendedsession ID/screening IDscreeningid
exc_1IntegerRecommendedFemale of childbearing potential who is not willing to use one of the specified forms of birth control during the study1::31=Yes; 2=No; 3=N/A
exc_2IntegerRecommendedFemale that is pregnant or breastfeeding1::31=Yes; 2=No; 3=N/Aexcs15, expregnt, ieca11_1
exc_3IntegerRecommendedFemale with a positive pregnancy test at screening or baseline1::31=Yes; 2=No; 3=N/A
exc_4IntegerRecommendedHistory 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 rater1;21=Yes; 2=No
exc_5IntegerRecommendedTotal 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 site1;21=Yes; 2=No
exc_6IntegerRecommendedCurrent 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 screening1;21=Yes; 2=Noelg_ct_history_dsm, elg_p_history_dsm, exabuse
exc_7IntegerRecommendedCurrent 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 more1;21=Yes; 2=No
exc_8IntegerRecommendedHistory of bipolar disorder, schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes1;21=Yes; 2=No
exc_9IntegerRecommendedHistory of anorexia nervosa, bulimia nervosa, or eating disorder nos, within 5 years of screening1;21=Yes; 2=No
exc_10IntegerRecommendedAny 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 screening1;21=Yes; 2=No
exc_11IntegerRecommendedIn the judgement of the investigator, the subject is considered at significant risk for suicidal behavior during the course of his/her participation in the study1;21=Yes; 2=No
exc_12IntegerRecommendedHas failed to respond to ECT during the current depressive episode1;21=Yes; 2=No
exc_13IntegerRecommendedHas received VNS at any time prior to screening1;21=Yes; 2=No
exc_14IntegerRecommendedHas dementia, delirium, amnestic, or any other cognitive disorder1::31=Yes; 2=No; 3=Current
exc_15IntegerRecommendedHas a clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results1;21=Yes; 2=No
exc_16IntegerRecommendedParticipation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation1;2; -7; -91=Yes; 2=No;-7=Refused; -9=Unknownexinvmed
exc_17aIntegerRecommendedKnown 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 visits1;21=Yes; 2=No
exc_17bIntegerRecommendedKnown history or current episode of recent myocardial infarction (within one year) or a history of myocardial infarction
1;2; -999
1=Yes; 2=No; -999=Don't know/Missing Data
exc_17cIntegerRecommendedKnown history or current episode of syncopal event within the past year1;21=Yes; 2=No
exc_17dIntegerRecommendedKnown history or current episode of congestive heart failure (CHF) New York Hear Association Criteria >Stage 21;21=Yes; 2=No
exc_17eIntegerRecommendedKnown history or current episode of angina pectoris1;21=Yes; 2=No
exc_17fIntegerRecommendedKnown history or current episode of heart rate <50 or >105 beats per minute at screening or randomization1;21=Yes; 2=No
exc_17gIntegerRecommendedExclusion 17g1;21=Yes; 2=No
exc_18IntegerRecommendedChronic lung disease excluding asthma1;21=Yes; 2=No
exc_19IntegerRecommendedLifetime 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 years1;21=Yes; 2=No
exc_20aIntegerRecommendedThyroid stimulating hormone (TSH) outside of the normal limits and clinically significant as determined by the investigator1;21=Yes; 2=No
exc_20bIntegerRecommendedPatients 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 screening1;21=Yes; 2=No
exc_20cIntegerRecommendedAny other clinically significant abnormal laboratory result1;21=Yes; 2=No
exc_21IntegerRecommendedHistory 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 enrollment1;21=Yes; 2=No
exc_22IntegerRecommendedHistory of hyperthyroidism which was treated (medically or surgically) less than 6 months prior to screening1;21=Yes; 2=No
exc_23IntegerRecommendedAny 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 interpretation1;21=Yes; 2=Noexmedcon
exc_24IntegerRecommendedHistory of positive screening urine test for drugs of abuse at screening: cannabinoids, cocaine, amphetamines, barbiturates, opiates1;21=Yes; 2=Noamish_exc2a
exc_25IntegerRecommendedPatients with exclusionary laboratory values or requiring treatment with exclusionary concomitant psychotropic medications1;21=Yes; 2=No
exc_26IntegerRecommendedPatients 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;21=Yes; 2=No
exc_27IntegerRecommendedPatients who have participated in studies of ketamine or AZD6765 or other NMDA receptor antagonists for depression and received active treatment1;21=Yes; 2=No
exc_28IntegerRecommendedPatients with narrow angle glaucoma1;21=Yes; 2=No
exc_29IntegerRecommendedPatients with a lifetime history of PCP/Ketamine drug use1;21=Yes; 2=No
exc_30IntegerRecommendedLiver Function Tests higher than 2.5 times upper limit of normal1;21=Yes; 2=No
inc_1IntegerRecommendedMale or female, 18-65 years of age, inclusive, at screening1;21=Yes; 2=Noieca1, incs8
inc_2IntegerRecommendedAble 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 information1;21=Yes; 2=Noincs9, inex_inc6
inc_3IntegerRecommendedDiagnosed 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-TR1;21=Yes; 2=No
inc_4IntegerRecommendedHas a history of TRD during the current MDE, as assessed by the investigator and remote centralized rater using the MGH ATRQ1;21=Yes; 2=No
inc_5IntegerRecommendedMeet 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 visit1;21=Yes; 2=No
inc_6IntegerRecommendedIn good general health, as ascertained by medical history, physical examination, clinical laboratory evaluations, and ECG1;21=Yes; 2=No
inc_7IntegerRecommendedIf female, a stus of non-childbearing potential or use of an acceptable form of birth control per1::31=Yes; 2=No; 3=NA
inc_8IntegerRecommendedBody mass index between 18-351;21=Yes; 2=No
inc_9IntegerRecommendedConcurrent 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 study1;21=Yes; 2=No
inc_10IntegerRecommendedConcurrent 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 study1;21=Yes; 2=No
scrfldtDateRecommendedDate of Screen Failure
scrflincString1,250RecommendedFailed these inclusion criteria:
scrflexcString500RecommendedFailed these exclusion criteria:
scrnflprIntegerRecommendedSelect the primary reason for screen failure
scrflothString250RecommendedOther reasons for failurereason_for_failure
stateIntegerRecommendedSubject state0::20=Screening; 1=Screened; 2=Failed
subject_groupString30RecommendedSubject Group_view_KETAMINE_ADVERSE_EVENT_LOG
iec001aIntegerRecommendedAge between 18 and 550;1;-90=No; 1=Yes; -9=Unknownelg_ct_age, elg_p_age
iec001bIntegerRecommendedInclusion: Negative Urine Toxicology0;1;-90=No; 1=Yes; -9=Unknown
iec001cIntegerRecommendedInclusion: No family history of schizophrenia in a first degree relative0;1;-90=No; 1=Yes; -9=Unknownelg_ct_dsm_relative
medprob_eyecolorblString50RecommendedColor blindness?
Yes;No
iec002j
iec002aIntegerRecommendedCurrent or past Axis I or II psychiatric history, (including substance abuse or dependence, with the exception of nicotine dependence)0;1;-90=No; 1=Yes; -9=Unknownieh002c
iec002bIntegerRecommendedCurrent (i.e., within the last 3 months) treatment with any psychotropic medications (as specified in protocol)0;1;-90=No; 1=Yes; -9=Unknownieh002g, inex_exc4
iec002cIntegerRecommendedPositive serum pregnancy test, lactation, or lack of use of effective birth control0;1;-90=No; 1=Yes; -9=Unknown
iec002dIntegerRecommendedPresence 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;-90=No; 1=Yes; -9=Unknown; -7=Refusedamish_exc2c
iec002eIntegerRecommendedPresence 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;-90=No; 1=Yes; -9=Unknownamish_exc2b, elg_ct_neuro_disease, elg_p_neuro_disease
hxvioIntegerRecommendedHistory of violence0;10=No; 1=Yesiec002f
iec002gIntegerRecommendedHistory 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;-90=No; 1=Yes; -9=Unknown
iec002hIntegerRecommendedContraindication 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;-90=No; 1=Yes; -9=Unknownamish_exc2i, elg_ct_metal_implants, elg_p_metal_implants, metallic
iec002iIntegerRecommendedMedicinal patch, unleess removed prior to the MR scan0;1;-90=No; 1=Yes; -9=Unknownamish_exc2j
lab020DateRecommendedDate of PI/clinician signatureiec004
iec003aIntegerRecommendedIs the subject eligible to participate in the study?
0;1;-9
0=No; 1=Yes; -9=Unknownelg_ct_yn, elg_p_yn, eligible, ieh003a, included
iec003dString50RecommendedOther reason not eligiblectl_not_elg, iea003d, ieh003d, notelg_case
cmd005_1IntegerRecommendedMedication route1::7; -91=Oral; 2=Intramuscular; 3=Intravenous; 4=Subcutaneous; 5=Inhalation; 6=Depot; 7=Other (specify below); -9=Unknown
cmd007_1IntegerRecommendedMedication units1::7; -91=Capsule/tablet; 2=Milligram; 3=Gram; 4=Cubic cm/mL; 5=Grains; 6=Ounce; 7=Other (specify below);-9=Unknown
cmd008_1IntegerRecommendedMedication Frequency1::7; -91=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_date1DateRecommendedDiscontinuation Date:cmd010a
rafq1IntegerRecommended1. Did participant meet criteria as a responder at Week 12 Assessment? (CGI-I of 1 or 2)0;10=No; 1=Yes
rafq2IntegerRecommended2. Did participant meet both Current CGI-S score of 4 or higher and current CGI-I score of 4 or higher0;10=No; 1=Yesincs10c
rafq3IntegerRecommended3. Potential Relapse identified on this assessment for this participant?0;10=No; 1=Yes
date_updatedDateRecommendedDate record updatededit_date
exc_26aIntegerRecommendedPatients currently taking a proton pump inhibitor (PPI)/histamine 2 (H2) blocker or with a history of chronic NSAID use.1;21=Yes; 2=Noexppi
exc_27aIntegerRecommendedPatients with a positive test for Helicobacter pylori (urea breath test).1;21=Yes; 2=No
exc_28aIntegerRecommendedPatients 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 disease1;21=Yes; 2=Noexgastr
ctnirc2IntegerRecommendedSubject passed MGH CTNI rater interview1;21=Yes; 2=No
ctnirc1IntegerRecommendedMedical Monitor approved subject for randomization1;21=Yes; 2=No
ctnirc3IntegerRecommendedDoes the subject meet SCID Mood Module Criteria?1;21=Yes; 2=No
ieca2_1IntegerRecommendedIs the patients BMI ? 27?0;10=No; 1=Yes
ieca5_1IntegerRecommendedIs the patients duration of illness greater than one year, as defined by having initiated antipsychotic treatment at least 1 year prior to enrollment?0;10=No; 1=Yes
ieca6_1IntegerRecommendedIs the patient currently being treated with one or, no more than, two antipsychotic medications?0;10=No; 1=Yes
ieca6bIntegerRecommendedHas the patients anti-psychotic medication dosages been stable for at least 1 month prior to study entry?0;10=No; 1=Yes
ieca7_1IntegerRecommendedIf 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::20=No; 1=Yes; 2=N/A
ieca8_1IntegerRecommendedIf 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::20=No; 1=Yes; 2=N/A
ieca9_1IntegerRecommendedHas the patient discontinued previous medication for weight loss one month prior to study entry0::20=No; 1=Yes; 2=N/A
ieca12_1IntegerRecommendedHas the patient been diagnosed with diabetes mellitus or being treated with insulin or oral hypoglycemics?0;10=No; 1=Yes
ieca13_1IntegerRecommendedHas the patient been diagnosed with congestive heart failure?0;10=No; 1=Yes
ieca14IntegerRecommendedIs the patient currently or previously been treated with metformin?0;10=No; 1=Yes
ieca15IntegerRecommendedDoes the patient have a known hypersensitivity to metformin?0;10=No; 1=Yesq13_8a
ieca17IntegerRecommendedIs the patients Clinical Global Impression Severity, CGI-S, score ? 6?0;10=No; 1=Yes
ieca19IntegerRecommendedIs the patients fasting glucose > 125?0;10=No; 1=Yes
ieca20IntegerRecommendedDoes 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;10=No; 1=Yes
ieca21IntegerRecommendedDoes the patient have hepatic disease, AST or ALT > 1.5 x upper limit of normal, ULN, or total bilirubin > 1.2 x ULN,?0;10=No; 1=Yes
ieca22IntegerRecommendedDoes the patient have metabolic acidosis0;10=No; 1=Yes
ieca23IntegerRecommendedHas the patient had recent, in the past 30 days, or scheduled radiological studies involving iodinated contrast material?0;10=No; 1=Yes
inex_inc1IntegerRecommendedBetween ages 6 and 170;10=No; 1=Yes
inex_inc3IntegerRecommendedSeverity of anxiety symptoms0;10=No; 1=Yes
inex_inc4IntegerRecommendedSeverity of overall impairment0;10=No; 1=Yes
inex_inc5IntegerRecommendedIn good physical health0;10=No; 1=Yesdb_inc7
inex_inc7IntegerRecommendedWritten informed consent age or assent0;1;-7;-90=No; 1=Yes; -9=unknown; -7=refused
inex_exc2IntegerRecommendedPast diagnosis of disorders0;10=No; 1=Yes
inex_exc3IntegerRecommendedCurrent diagnosis of disorders0;10=No; 1=Yes
inex_exc5IntegerRecommendedRecent treatment with psychotropic meds0;10=No; 1=Yes
inex_exc6IntegerRecommendedCurrently uses psychoactive drugs/alcohol0;10=No; 1=Yes
inex_exc9IntegerRecommendedSexually active Female without Birth control0;10=No; 1=Yes
inex_exc10IntegerRecommendedIQ less than 700;10=No; 1=Yes
inmddIntegerRecommendedIN: meets DSM-IV criteria0;1;-7;-90=No; 1=Yes; -9=unknown; -7=refuseddb_inc2, inex_inc2
chartreview021IntegerRecommendedSuicidal ideation0::3; 9; -888; -9990=No; 1=Yes,in past week; 2=Yes, >1 week ago; 3=Yes, no time specified; 9=Not Documented;-888=Not Applicable;-999=Missing;inex_exc7
completedIntegerRecommendedChecks if form is completed0::20=No; 1=Yes; 2=Yes, lostfrmcomp, inex_frmcomp
incs7IntegerRecommendedSchizophrenia/schizoaffective disorder patient whose clinician is considering long-term treatment with a second-generation antipsychotic medication0;10=No; 1=Yes
incs10IntegerRecommendedSubject has had an exacerbation of his/her illness within the last 12 months.0;10=No; 1=Yes
incs10bIntegerRecommendedIncreased level of care required, defined by an increase in clinic visits, emergency room visits or a change from general outpatient status to day hospital participation0;10=No; 1=Yes
incs10aIntegerRecommendedHospitalization0;10=No; 1=Yes
excs11IntegerRecommendedFirst episode patients.0;10=No; 1=Yes
excs12IntegerRecommendedPatients with a known allergy to risperidone.0;10=No; 1=Yesdb_exc4
excs13IntegerRecommendedPatients with a past negative response to risperidone that is not explained by treatment non-adherence.0;10=No; 1=Yes
excs14IntegerRecommendedPatients with a previous history of failure to respond to an adequate trial of clozapine.0;10=No; 1=Yes
reass19IntegerRecommendedExperimental research study0;10=No; 1=Yes
reass20IntegerRecommendedRandomized drug treatment0;10=No; 1=Yes
reass21IntegerRecommendedInjection0;10=No; 1=Yes
reass22IntegerRecommendedDenial of need for medication0;10=No; 1=Yes
reass23IntegerRecommendedDenial of illness0;10=No; 1=Yes
reass24IntegerRecommendedStudy burden0;10=No; 1=Yes
reass25IntegerRecommendedDesire to be transferred elsewhere0;10=No; 1=Yes
reass26IntegerRecommendedUncooperativeness0;10=No; 1=Yes
reass26_1IntegerRecommendedDoes not want to change current meds0;10=No; 1=Yes
otherIntegerRecommendedOther::0;1;9990 = No; 1 = Yesreass27
otherspecifyString255RecommendedSpecify otherreass27t
intrtIntegerRecommendedTreatment Status Code0::20=Baseline; 1=In Treatment; 2=In Follow-up
trtgrp_pIntegerRecommendedTreatment Group1;21=Long-Acting Injectable Risperidone Microspheres; 2=Second Generation Oral Antipsychotic Medication
days_visit1IntegerRecommendedDays from Visit 1dav1scrn
visnumFloatRecommendedNumeric 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
diageIntegerRecommendedMajor Depressive Disorder Diagnosis Clinical
0;1
0=No; 1=Yesmddyn
bpi4aIntegerRecommendedBIPOLAR I DISORDER.
0;1
0=no; 1=yesbp1yn
bpii4aIntegerRecommendedBIPOLAR II DISORDER.
0;1
0=no; 1=yesbp2yn
ga4aIntegerRecommendedGENERALIZED ANXIETY DISORDER.
0;1
0=no; 1=yesgadyn
so4aIntegerRecommendedSOCIAL PHOBIA.
0;1
0=no; 1=yesspyn
pd4a1IntegerRecommendedPANIC DISORDER.
0;1
0=no; 1=yespdyn
medhx_ptsdIntegerRecommendedPost Traumatic Stress Disorder
0::2
0 = No, 1 = Yes, 2 = Not sureptsdyn
incageIntegerRecommendedAge between 21 and 65 years of age
incdxIntegerRecommendedMust 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 Disorder0;10=no; 1=yes
incshapsIntegerRecommendedSnaith-Hamilton Pleasure Scale (SHAPS) score > 200;10=no; 1=yes
incavailIntegerRecommendedReliable and willing to be available for the duration of the study0;10=no; 1=yes
incmbircIntegerRecommendedIf 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 afterward0;10=no; 1=yes
waivergString2RecommendedWas a waiver granted?Y;N
waivedtDateRecommendedDate waiver granted
exdrugIntegerRecommendedUse 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 study0;1; -7;-90=no; 1=yes;-7=Refused; -9=Unknown
exmdrugIntegerRecommendedUse of any medication that is primarily metabolized by Cytochrome P450 2C8 within 14 days of baseline or at any time during study.0;10=no; 1=yes
eximageIntegerRecommendedAny contraindications to the magnetic resonance imaging procedures0;10=no; 1=yes
exurineIntegerRecommendedPositive urine drug screen at any time during the study0;10=no; 1=yes
exhyperIntegerRecommendedKnown hypersensitivity to LY24563020;10=no; 1=yes
exallergIntegerRecommendedHistory of allergy to protocol meds0;10=No; 1=Yes
exsalviaIntegerRecommendedHistory of use of Salvia divinorum or use of Salvia divinorum at any time during the study.0;10=no; 1=yes
exsmokeIntegerRecommendedAny smoking of cigarettes within the last month or at any time during the study0;10=no; 1=yes
exdxIntegerRecommendedCurrent/history of a psychotic disorder, current manic or mixed episode, autism spectrum disorders, mental retardation0;10=no; 1=yes
exhosp1IntegerRecommendedExpected to require hospitalization during the course of the study0;10=no; 1=yesexhosp
db_inc1IntegerRecommendedBetween age 5 - 17.2 months0;10=No; 1=Yes
db_inc3IntegerRecommendedMedication free0;10=No; 1=Yes
db_inc4IntegerRecommendedFree of anticonvulsants0;10=No; 1=Yes
db_inc5IntegerRecommendedAchieves scores (CGI,ABC,Ritvo-Freeman)0;10=No; 1=Yes
db_inc6IntegerRecommendedMental Age of 18 months0;10=No; 1=Yes
db_exc1IntegerRecommendedIQ below mental age of 18 months0;10=No; 1=Yes
db_exc2IntegerRecommendedFemale with positive Beta HCG test0;10=No; 1=Yes
db_exc3IntegerRecommendedPrior adequate trial with risperidone0;10=No; 1=Yes
db_exc5IntegerRecommendedHistory, neuroleptic malignant syndrome0;10=No; 1=Yes
db_exc8IntegerRecommendedWeight is less than 20 kg0;10=No; 1=Yes
ol_inc4IntegerRecommendedInpatients or outpatients0;10=No; 1=Yes
ol_inc1IntegerRecommendedDecreased ABC and CGI Improvement0;10=No; 1=Yes
ol_inc5IntegerRecommendedNo need for other psychotropic meds0;10=No; 1=Yes
ol_inc6IntegerRecommendedAnticonvulsants: stable for 4 wks and seizure free for at least 6 months0;1; 9990=No; 1=Yes; 999=NA
prescrn_q13_1IntegerRecommendedSubject excluded for age1;2;-7;-91=Yes;2=No; -7=refused; -9 = unknownq13_1
prescrn_q13_7aIntegerRecommendedSubject excluded for unstable AC med1;21=Yes;2=Noq13_7a
prescrn_q13_8IntegerRecommendedSubject excluded for prior trt1;21=Yes;2=Noq13_8
prescrn_q13_8bIntegerRecommendedSubject exluded for Adverse Event1;21=Yes;2=Noq13_8b
prescrn_q13_8cIntegerRecommendedSubject exluded for Serious Adverse Event1;21=Yes;2=Noq13_8c
prescrn_q13_10IntegerRecommendedSubject excluded for med free1;21=Yes;2=Noq13_10
prescrn_q13_oIntegerRecommendedSubject excluded for other reason1;21=Yes;2=Noq13_o
prescrn_q14IntegerRecommendedOther action(s) taken1;21=Yes;2=Noq14
prescrn_q15IntegerRecommendedWill participate, pharm studies1;21=Yes;2=Noq15
prescrn_q16IntegerRecommendedWill participate, non-pharm studies1;21=Yes;2=Noq16
studyString100RecommendedStudygroup, studyid
ci_enrolledIntegerRecommendedParticipant enrolled0;10=No; 1=Yesenrolled
pcc001IntegerRecommendedWas follow-up phone call conducted0;1;-90=No; 1=Yes; -9=Unknown
dmg_referralIntegerRecommendedreferral source1::11;991=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
refothersString50RecommendedReferral source: specify
stable_doseIntegerRecommendedStable Dose for 4 weeks0;1;-90=No;1=Yes;-9=Unknown
iec_hyprispIntegerRecommendedHypersensitivity to Risperidone0;1;-90=No;1=Yes;-9=Unknown
appointment_sIntegerRecommendedAppointment scheduled0;1;-90=No;1=Yes;-9=Unknown
appointment_dIntegerRecommendedWhen appointment was scheduleddays from randomization date
appointment_tString8RecommendedTime appointment was scheduled
follow_callIntegerRecommendedWhen follow up call was conducteddays from randomization date
ieh002dIntegerRecommendedFirst-degree relative with DSM-5 Autism Spectrum Disorder0;1; 2;-90=No; 1=Yes; 2 = I do not wish to disclose; -9=Unknown
doa_futdtString20RecommendedFuture date entered (Assessment)elg_ct_doa_futdt, elg_p_doa_futdt
dodeString10RecommendedDate of Data Entryelg_ct_dode, elg_p_dode
dode_futdtString20RecommendedFuture date entered (Data Entry)elg_ct_dode_futdt, elg_p_dode_futdt
form_completedIntegerRecommendedWas the form completed?1;21=Yes; 2=Noelg_ct_form_complete, elg_p_form_complete
form_explainIntegerRecommendedWhy was this form not completed?86::9999=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 Applicableelg_ct_explain, elg_p_explain
other_reason_ncString100RecommendedOther reason form was not completedelg_ct_other_reason_nc, elg_p_other_reason_nc
assessment_completeIntegerRecommendedComplete?0::20=Incomplete; 1=Unverified; 2=Completeeligibility_checklist_case_complete, eligibility_checklist_control_complete
elg_p_dsmIntegerRecommendedDSM-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;10=No; 1=Yes
elg_p_no_change_in_medsIntegerRecommendedNo change in antipsychotic medication or decrement in functioning/support level in the last 30 days0;10=No; 1=Yeselg_ct_no_change_in_meds
dem_18tIntegerRecommendedMental retardation0;11=Yes 0=Noelg_ct_iq_71, elg_p_iq_71
elg_p_prior_psychosurgeryIntegerRecommendedPrior psychosurgery0;10=No; 1=Yeselg_ct_prior_psychosurgery
mdga12IntegerRecommendedDiagnosed with: Diabetes Type I (insulin dependent)0;10=No; 1=Yeselg_ct_type_1_dm, elg_p_type_1_dm
phne_sc_37String5RecommendedHealth/ Medical.5. Have you ever had a brain injury (TBI=traumatic brain injury, brain lesion, loss of consciousness for more than 30 minute)?Yes;Noelg_ct_history_head_trauma, elg_p_history_head_trauma
elg_p_debilitating_illnessIntegerRecommendedSignificantly debilitating medical illnesses (e.g. encephalitis, aneurysms, tumors, or Central Nervous System (CNS) infections)0;10=No; 1=Yeselg_ct_debilitating_illness
elg_p_intellect_disabilityIntegerRecommendedSuspected DSM-5 intellectual disability based upon clinical interview and psychosocial history0;10=No; 1=Yeselg_ct_intellect_disability
ec12IntegerRecommendedExclusion criteria EC12: Is the patient non-English speaking?0::20 = No; 1 = Yes; 2 = Not Assessedelg_ct_eng_speaker, elg_p_eng_speaker
elg_caseString100RecommendedEligible specifyctl_elg
elg_ct_dsmIntegerRecommendedAbsence 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;10=No; 1=Yes
iec_yearsIntegerRecommended18-60 years old male or female0;10=No; 1=Yesyears
major_medIntegerRecommendedMajor 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;10=No; 1=Yes
major_neurIntegerRecommendedMajor 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;10=No; 1=Yes
iec_iqIntegerRecommendedSS < 60 for the WRAT-IV - Word Reading Green Form OR ESL and SS < 60 for the WASI-Matrix Reasoning0;10=No; 1=Yes
ss_matrixreasoningrawscoreIntegerRecommendedMatrix Reasoning Raw - Score0 :: 35wasi_raw
wasi_passIntegerRecommendedWASI-Matrix Reasoning SS > 60?0;10=No; 1=Yes
wrat_greenpassIntegerRecommendedWRAT-IV - Word Reading Green Form SS > 60?0;10=No; 1=Yes
wr_rawscoreIntegerRecommendedWord Reading Raw Score0 :: 70;-9;999999 = Missing valuewratgreen_raw
esl_registryIntegerRecommendedEnglish is second language (ESL)?0;10=No; 1=Yes
iec_lifetimeIntegerRecommendedLifetime DSM diagnosis of bipolar I disorder (with or without psychotic features)0;10=No; 1=Yeslifetime
iec_capableIntegerRecommendedCapable of completing the study procedures as judged by study investigators0;10=No; 1=Yescapable
iec_healthyIntegerRecommendedHealthy 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 relatives0;1;-9;-70=No; 1=Yes; -7=Refused; -9=Unknownhealthy
longitudinalIntegerRecommendedLongitudinal Study0;10=No; 1=Yes, Longitudinal Study
diagnosis_other_specifyString500RecommendedWhat other diagnoses has the participant had?
dsmdmIntegerRecommendedDepressed mood0;10=Not checked; 1=Checked
irritabilityString10RecommendedIrritabilityYes; No; Unknown
gen_rater_26IntegerRecommendedSleep disturbance, especially difficulty falling asleep.1;2; 91 = Yes; 2 = No; 9 =unable to answer
social_anhedonia_presentString10RecommendedSocial anhedonia presentabsent;present
cdrs5buIntegerRecommendedAppetite disturbance: Best Description1::5; -91 = 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
dyb5IntegerRecommendedPoor concentration or difficulty making decisions0::3; -70=Inadequate information; 1=Absent or false; 2=Subthreshold; 3=Threshold or true; -7 =refused
q17_b1bIntegerRecommendedTired worn out or fatigued-7;-8;-9;0;1Complete only if primary question equals 1
exambat220IntegerRecommendedAgitation0::30=None;1=Mild;2=Moderate;3=Severe
adsq6_uIntegerRecommendedPresence of Symptom: Feeling guilty or bad about things (Non-imputed Version)0;10= No; 1= Yes
worthledIntegerRecommendedWorthlessness0;10=No; 1=Yes
aer028aIntegerRecommendedIncreased Energy0::3; -90=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
scrn_currsi_aIntegerRecommendedSuicide ideation, current0;1; -888; -9990=No; 1=Yes; -888=Not Applicable; -999=Missing
medication1_weeksFloatRecommendedTotal weeks of medication 1
medication1_dosageString50RecommendedFirst medication dosage
medication2_dosageString50RecommendedSecond medication dosage
medication1_nameString100RecommendedName first medication that the participant has taken999= Legitimately skipped;
medication2_nameString100RecommendedName second medication that the participant has taken999= Legitimately skipped;
weekFloatRecommendedWeek in level/study99=week 10-week 14
p2i9IntegerRecommendedMajor Depressive Episode - Current episode psychosis1;21=no;2=yes
icdcd40IntegerRecommendedDid the patient have a CDRS Score of 40 or greater at the wk 0 visit?0;10 = Not Checked; 1 = Checked
icdssriIntegerRecommendedDid the patient have an adequate trial of only 1 SSRI?0;10 = Not Checked; 1 = Checked
icdcdrsIntegerRecommendedDid 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;10 = Not Checked; 1 = Checked
i1e15IntegerRecommendedDSM-IV Developmental Disorder0;10 = Not Checked; 1 = Checked
e8IntegerRecommendedExcluded because of Weight0;10 = Not Checked; 1 = Checked
i1e3IntegerRecommendedHistory of failure to respond to 2 or more SSRIs0;10 = Not Checked; 1 = Checked
i1e1IntegerRecommendedHistory of failure to respond to CBT0;10 = Not Checked; 1 = Checked
i1e2IntegerRecommendedHistory of failure to respond to venlafaxine0;10 = Not Checked; 1 = Checked
i1e7IntegerRecommendedOrganic Mental Disorder0;10 = Not Checked; 1 = Checked
i2IntegerRecommendedSix Weeks of Adequate Treatment0;10 = Not Checked; 1 = Checked
i2e14IntegerRecommendedTime commitment - not willing to come in to clinic for 12 weeks0;10 = Not Checked; 1 = Checked
icdcompIntegerRecommendedWas the patient compliant with the SSRI?0;10 = Not Checked; 1 = Checked
icddsmIntegerRecommendedWas the patient diagnosed with Major Depressive Disorder (MDD) and/or Dysthymia according to DSM-IV criteria at the wk 0 visit?0;10 = Not Checked; 1 = Checked
prerandIntegerRecommendedWas the patient pre-randomized?0;10 = Not Checked; 1 = Checked
exclmedIntegerRecommendedConcomitant use of excluded medications0;10=Not checked; 1=Checked
icdhidoIntegerRecommendedIf the patient was taking a concomitant medication allowed by the study Protocol, was the dose within the allowed limits?0;10 = Not Checked; 1 = Checked
amish_inc1aIntegerRecommendedMale or Female, ages 18-590; 1; -90=No; 1=Yes; -9= NK
amish_inc1bIntegerRecommendedSubject is from the Old-Order Amish population0; 1; -90=No; 1=Yes; -9= NK
amish_inc1cIntegerRecommendedMeets DSM-5 diagnostic criteria for psychotic disorder, including SCZ/schizoaffective disorder (SAD) or psychotic disorder not elsewhere classified (PDNEC)0; 1; -90=No; 1=Yes; -9= NK
amish_inc1dIntegerRecommendedGenetically confirmed that patient carries CNTNAP2 mutation0; 1; -90=No; 1=Yes; -9= NK
amish_inc1eIntegerRecommendedA 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 history0; 1; -90=No; 1=Yes; -9= NK
amish_inc1fIntegerRecommendedIn 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 study0; 1; -90=No; 1=Yes; -9= NK
amish_inc1gIntegerRecommendedGenetically confirmed that patient does not carry CNTNAP2 mutation0; 1; -90=No; 1=Yes; -9= NK
amish_inc1hIntegerRecommendedHas first-degree relative of Old-Order Amish subject with CNTNAP2 mutation0; 1; -90=No; 1=Yes; -9= NK
amish_exc2dIntegerRecommendedLow hemoglobin (Hb < 13 g/dL in males, Hb < 11 g/dL in females)0; 1; -90=No; 1=Yes; -9= NK
amish_exc2eIntegerRecommendedLifetime 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; -90=No; 1=Yes; -9= NK
amish_exc2fIntegerRecommendedBlood donation within eight weeks of study0; 1; -90=No; 1=Yes; -9= NK
amish_exc2gIntegerRecommendedPresence of clinically significant brain abnormalities0; 1; -90=No; 1=Yes; -9= NK
amish_exc2hIntegerRecommendedPositive Pregnancy test (for female subjects of child-bearing age who are not surgically sterilized and between menarche and 1 year postmenopausal)0; 1; -90=No; 1=Yes; -9= NK
amish_exc2kIntegerRecommendedUse of the medications that would interfere with mGluR5 binding, including lamotrigine, gabapentin, topiramate, phenobarbital, pregabalin, zonisamide, N-acetylcysteine, D-cycloserine, clozapine0; 1; -90=No; 1=Yes; -9= NK
amish_exc2lIntegerRecommendedAffected subjects: Current treatment with clozapine and/or medications other than antipsychotics/PRN anxiolytics0; 1; -90=No; 1=Yes; -9= NK
amish_exc2mIntegerRecommendedUnaffected subjects: Lifetime history of antipsychotic or antidepressant use0; 1; -90=No; 1=Yes; -9= NK
iec_lifetime_psycqIntegerRecommendedLifetime DSM diagnosis of bipolar I disorder (with psychotic features)0;10=No; 1=Yes
asap10cIntegerRecommendedoutside clinicians/services: Outside psychotherapy for patient0;10 = No;1 = Yes
inc_5aIntegerRecommendedIs the minimum score on the HAM-D at screen and at baseline greater than or equal to 200;10=No; 1=Yes
gafcutoffIntegerRecommendedGAF rating of 60 or below (moderate or worse impairment)0;10=No; 1=Yes
depdecreaseIntegerRecommendedDid the total score on the HAM-D decrease by 25% or more between screening and baseline0;10=No; 1=Yes
disp3IntegerRecommendedIs this subject being seen at a satellite site?1;21=Yes; 2=No
reas09IntegerRecommendedMet exclusion criteria0;10=No; 1=Yes
reas08IntegerRecommendedFailed inclusion criteria0;10=No; 1=Yes
ran002IntegerRecommendedWas the subject randomized?0::3; -90=No; 1=Yes; -9=unknown; 2=No meds; 3=No community care
exclus2IntegerRecommendedExclusion Criteria: Is confined to a jail or to a juvenile justice facility or county-ordered treatment0;10=No; 1=Yes
exclus3IntegerRecommendedExclusion Criteria: Is already in treatment and the current treatment seems to be effective in treating their depression and decreasing risk for recurrence of suicidal behavior0;10=No; 1=Yes
exclus6IntegerRecommendedExclusion 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 algorithm0;10=No; 1=Yes
exclus8IntegerRecommendedExclusion Criteria: Subject or parent does not speak English or Spanish0;1; -7;-90=No; 1=Yes;-7=Refused; -9=Unknown
exclus10IntegerRecommendedExclusion Criteria: Another family member is participating in trial0;10=No; 1=Yes
inclus1IntegerRecommendedInclusion 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;10=No; 1=Yes
inclus4IntegerRecommendedInclusion Criteria: Estimated IQ>=70. (average IQ subtest score >=6 on the voccabulary and block design subtests of the WISC-IV).0;10=No; 1=Yes
inclus5IntegerRecommendedInclusion 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 form0;1;-7;-90=No; 1=Yes; -9=unknown; -7=refused
scrnfailIntegerRecommendedSubject does not meet Inclusion/Exclusion Criteria and is a Screen Fail.0;10=No; 1=Yes
strcmtwIntegerRecommendedIf yes: is the subject being referred to the Steering Committee for review?0;10=No; 1=Yes
subrevIntegerRecommendedWas the subject reviewed by Committee?0;1;90=No; 1=Yes; 9=NA
commitdayIntegerRecommendedDate of Committee Meeting (days from baseline)
subrandIntegerRecommendedShould 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)
days_baselineIntegerRecommendedDays since baseline
sui3mosIntegerRecommendedsuicide attempt last 3 mos0;1;-70=No; 1=Yes; -7=Refused
enrollnIntegerRecommendedWas subject enrolled0;10=No; 1=Yes
excl03IntegerRecommendedSignificant medical condition0;1;-7;-90=No; 1=Yes; -7=refused; -9=unknown
tourettes_symptomsIntegerRecommendedTourette's syndrome: Had symptoms0;1;-7;-8;-90 = No; 1 = Yes; -7 = Don't know; -8 = Refused to answer; -9 = Does not apply
excl06IntegerRecommendedSubject weighs less than 16 kg0;1;-7;-90=No; 1=Yes; -7=refused; -9=unknown
excl07IntegerRecommendedHypersensitive to Guanfacine0;1;-7;-90=No; 1=Yes; -7=refused; -9=unknown
excl08IntegerRecommendedExclusion criteria exception used for this subject ?0;1;-7;-90=No; 1=Yes; -7=refused; -9=unknown
incl02IntegerRecommendedAge 4 years 6 months to 14 years of age inclusive0;10=No; 1=Yes
incl04IntegerRecommendedMed free CGI for PDD >= 40;1;-7;-90=No; 1=Yes; -7=refused; -9=unknown
incl05IntegerRecommendedMeet parent and teacher SNAP-IV criteria0;1;-7;-90=No; 1=Yes; -7=refused; -9=unknown
incl08IntegerRecommendedFluent 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;-91 = (n=529) YES; 0 = (n=4) NO; -7 = refused; -9 = unknown
incl09IntegerRecommended2.5 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;-91 = (n=568) YES; 0 = (n=8) NO; -7 = refused; -9 = unknown
incl10IntegerRecommendedTeacher 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;-91 = (n=564) YES; 0 = (n=4) NO; -7 = refused; -9 = unknown
incl11IntegerRecommended8 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;-91 = (n=565) YES; 0 = (n=8) NO; -7 = refused; -9 = unknown
ss_q3IntegerRecommendedMeet Inclusion and not exclusion0;10 = (n=275) NO; 1 = (n=321) YES
ci_continueIntegerRecommendedParticipant continuing in study0; 10=No; 1=Yes
np_reason_not_continuString500RecommendedReason for not continuing
q1_11IntegerRecommendedHas child ever been diagnosed with Rett Disorder or Child Disintegrative Disorder0;1
mini_other2IntegerRecommendedOther specified schizophrenia spectrum and other psychotic disorder: lifetime0;10=No; 1=Yes
exclus7IntegerRecommendedCurrent diagnosis of major depression, obsessive-compulsive disorder, or substance abuse (which would require alternative treatment)0;10 = No; 1 = Yes
commitd1IntegerRecommendedDate of Committee meeting (days since randomization
sigd1IntegerRecommendedPhysician/PI signature date (days since randomization)
weight_stdFloatRecommendedWeight - Standard Unit-1 = Not known
dsm_diagIntegerRecommendedDSM-IV PDD Diagnosis, type1::31=Autistic Disorder; 2=Asperger's; 3=PDD-NOS
cgisrespIntegerRecommendedCGIS ResponseCGI 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
outheaprIntegerRecommendedGeneral Services Use: Outpatient health provider0;20 = No; 2 = Yes
iqIntegerRecommendedIQ score as defined by the completion of an appropriate assessement
pdas_bb_maIntegerRecommendedMental Age
ruppageIntegerRecommendedMale or Female between the ages of 4 and 13 years0;10 = No; 1 = Yes
inclus2IntegerRecommendedBody weight greater than or equal to 14 kg (30.8 lbs)0;10 = No; 1 = Yes
inclus3IntegerRecommendedDSM-IV Diagnosis of Autistic Disorder, Asperger's Disorder, or Pervasive Development Disorder-NOS0;10 = No; 1 = Yes
pabcirrFloatRecommendedScore on Irritability subscale of the Parent-rated Aberrant Behavior Checklist (PABC)
inclus_pabcirrIntegerRecommendedScore greater than or equal to 18 on Irritability subscale of the Parent-rated Aberrant Behavior Checklist0;10 = No; 1 = Yes
inclus7IntegerRecommendedMedication-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 taper0;10 = No; 1 = Yes
inclus9IntegerRecommendedAn 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 Mullen0;10 = No; 1 = Yes
chkone9IntegerRecommendedHow was IQ or mental age determined?1::31 = Stanford-Binet; 2 = Mullen; 3 = Leiter
subaccepIntegerRecommendedIf subject reviewed by committee, was the subject accepted for enrollment?0;10 = No; 1 = Yes
Data Structure

This page displays the data structure defined for the measure identified in the title and structure short name. The table below displays a list of data elements in this structure (also called variables) and the following information:

  • Element Name: This is the standard element name
  • Data Type: Which type of data this element is, e.g. String, Float, File location.
  • Size: If applicable, the character limit of this element
  • Required: This column displays whether the element is Required for valid submissions, Recommended for valid submissions, Conditional on other elements, or Optional
  • Description: A basic description
  • Value Range: Which values can appear validly in this element (case sensitive for strings)
  • Notes: Expanded description or notes on coding of values
  • Aliases: A list of currently supported Aliases (alternate element names)
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Distribution for DataStructure: iec01 and Element:
Chart Help

Filters enable researchers to view the data shared in NDA before applying for access or for selecting specific data for download or NDA Study assignment. For those with access to NDA shared data, you may select specific values to be included by selecting an individual bar chart item or by selecting a range of values (e.g. interview_age) using the "Add Range" button. Note that not all elements have appropriately distinct values like comments and subjectkey and are not available for filtering. Additionally, item level detail is not always provided by the research community as indicated by the number of null values given.

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