NIMH Data Archive - Data Dictionary: Data Structure

Clinical Trials: Inclusion/Exclusion Criteria

10,986 Shared Subjects

Description Clinical Trials: Inclusion/Exclusion Criteria

Data type Clinical Assessments

Categories

Enrollment

Date created 06/25/2014

Short name iec01

Most Recent Update 04/15/2024
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Version 01

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Definition

Submission Template

Query	Element Name	Data Type	Size	Required	Description	Value Range	Notes	Aliases
	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;1	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;1	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?	0;1	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;1; -9	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;1; -9	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)?	0;1	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;1;999	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::3	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;2	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;2; -9	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;2; -7; -9	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;2; -999	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;2	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;2; -9	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;2; -9	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::3; -9	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?	Yes;No		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;1;-9	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;2	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;2	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;1	0=No; 1=Yes	mddyn
Query	bpi4a	Integer		Recommended	BIPOLAR I DISORDER.	0;1	0=no; 1=yes	bp1yn
Query	bpii4a	Integer		Recommended	BIPOLAR II DISORDER.	0;1;998;999	0=no; 1=yes; 998=N/A; 999=Missing	bp2yn
Query	ga4a	Integer		Recommended	GENERALIZED ANXIETY DISORDER.	0;1	0=no; 1=yes	gadyn
Query	so4a	Integer		Recommended	SOCIAL PHOBIA.	0;1	0=no; 1=yes	spyn
Query	pd4a1	Integer		Recommended	PANIC DISORDER.	0;1	0=no; 1=yes	pdyn
Query	medhx_ptsd	Integer		Recommended	Post Traumatic Stress Disorder	0::2	0 = No, 1 = Yes, 2 = Not sure	ptsdyn
Query	incage	Integer		Recommended	Age between 21 and 65 years of age	0;1	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;1	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;1	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;1	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;1; -7;-9	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;1	0=no; 1=yes
Query	eximage	Integer		Recommended	Any contraindications to the magnetic resonance imaging procedures	0;1	0=no; 1=yes
Query	exurine	Integer		Recommended	Positive urine drug screen at any time during the study	0;1; -9	0=No; 1=Yes; -9 = Unknown	poma_iec002b
Query	exhyper	Integer		Recommended	Known hypersensitivity to LY2456302	0;1	0=no; 1=yes
Query	exallerg	Integer		Recommended	History of allergy to protocol meds	0;1	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;1	0=no; 1=yes
Query	exsmoke	Integer		Recommended	Any smoking of cigarettes within the last month or at any time during the study	0;1	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;1	0=no; 1=yes
Query	exhosp1	Integer		Recommended	Expected to require hospitalization during the course of the study	0;1	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;Y; NK	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;2;99	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;1	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;1	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;1	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;1	0 = No; 1 = Yes
Query	incl_excl_tfcg_0tics	Integer		Recommended	Tic-free Control Group : No history of tic	0;1	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;1	0 = No; 1 = Yes
Query	incl_excl_sec_tics	Integer		Recommended	Exclusion Criteria: Secondary tics	0;1	0 = No; 1 = Yes
Query	incl_excl_migraine	Integer		Recommended	Exclusion Criteria: Another neurological disorder (not counting migraine)	0;1	0 = No; 1 = Yes
Query	incl_excl_brain_disease	Integer		Recommended	Exclusion Criteria: Structural brain disease	0;1	0 = No; 1 = Yes
Query	incl_excl_system	Integer		Recommended	Exclusion Criteria: Severe systemic illness	0;1	0 = No; 1 = Yes
Query	incl_excl_ess_trem	Integer		Recommended	Exclusion Criteria: Other movement disorders including essential tremor	0;1	0 = No; 1 = Yes
Query	incl_excl_nonprof	Integer		Recommended	Exclusion Criteria: Nonproficiency in the English language	0;1	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;1	0 = No; 1 = Yes
Query	incl_excl_meds	Integer		Recommended	Exclusion Criteria: Psychoactive meds	0;1	0 = No; 1 = Yes
Query	incl_excl_med_change	Integer		Recommended	Exclusion Criteria: Psychoactive meds: Change in dose in the past month?	0;1	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;1;3	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;1	0 = No; 1 = Yes
Query	incl_excl_eligible	Integer		Recommended	Was the subject deemed eligible for study by the P.I.?	0;1	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?	Yes; No		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

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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Clinical Trials: Inclusion/Exclusion Criteria

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Clinical Trials: Inclusion/Exclusion Criteria