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Clinical Trials: Inclusion/Exclusion Criteria

7,341 Shared Subjects

Clinical Trials: Inclusion/Exclusion Criteria
Clinical Assessments
Enrollment
06/25/2014
iec01
11/14/2019
View Change History
01
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 Required field IECDate, 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 :: 1260 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 the subject M;F M = Male; F = Female gender, iec13a, rdm13, sex
Query aescode Integer Recommended Staff code number of person completing this form IECCODE
Query visit String 50 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 consent, 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 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 100 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 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 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 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 100 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 200 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
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 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 0= Unchecked; 1= Checked 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
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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