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NIMH Data Archive
NDA ABCD CCF OAI NIAAADA AMP SCZ HEAL NBB

Treatment Variables

1,881 Shared Subjects

Clinical Trials: Treatment Variables
Clinical Assessments
Summary
05/07/2014
keyvars01
12/16/2022
View Change History
01
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*
src_subject_id String 20 Required Subject ID how it's defined in lab/project CATIEID
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY
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.
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported gender
Query siteno Integer Recommended Site ID
sitepool String 30 Recommended Pooled Site - Phase 1/1A Sites with 15 or fewer randomized patients were combined together or with a larger site, based on site care setting and geograhical region.
Query scrnpop Integer Recommended All Screened Subjects 0;1; -888; -999 0=No; 1=Yes; -888=Not Applicable; -999=Missing
Query multscrn Integer Recommended Flag for subjects screened multiple time 0;1 0=No; 1=Yes
Query failreas Integer Recommended Reason for Screen Failure 1::16 1=Patient did not want to change current typical antipsychitic med; 2 = Patient did not want to change current atypical antipsychitic med; 3 = Patient did not meet inclusion or exclusion criteria; 4 = Patient not able to make informed consent; 5 = Patient refusal - other reason; 6 = Other; 7=NA; 8=Did not meet diagnostic criteria; 9= Clinical or unstable medical disorder; 10= Moderate or severe substance use;11 =Pregnant, breastfeeding or planning on becoming pregnant; 12=Currently taking broccoli supplement; 13 = Substance- or medically-induced mood symptoms; 14 = Celiac disease; 15 = Receipt of ECT within 30 days prior to Visit 1/Baseline; 16 = Participation in any drug trial in the 30 days prior to Visit 1/Baseline
Query comp_s Integer Recommended Completed Study 0;1 0=No; 1=Yes cybb_complete, ipsm_skip
Query dcr_s Integer Recommended Reason for Discontinuation from Study 1::7 1 = Administrative; 2 = Patient refusal to continue; 3 = Adverse Event; 4 = Other; 5 = Unavailable as of database cutoff date; 6=caregiver refusal; 7=patient death
Query es_day Integer Recommended Day Discontinued from Study Number of days from study baseline to date of study discontinuation (excluding follow-up phase) Based on visit dates
Query lastphas String 20 Recommended Last phase patient was in prior to ending study
Query in_fu Integer Recommended In follow-up Phase 1 1=Yes
Query rand_1 Integer Recommended Randomized in Phase 1 0;1 0=No; 1=Yes
Query rand_1a Integer Recommended Randomized in Phase 1A 0;1 0=No; 1=Yes
Query rand1_1a Integer Recommended Randomized in Phase 1/1A 0;1 1=Yes for patients randomized into either Phase 1 or Phase 1A; 0 otherwise
Query b1_day Integer Recommended Baseline Day - Phase 1/1A Number of days from study baseline to first day of the phase Based on visit dates
Query e1_day Integer Recommended Day Discontinued from Phase 1/1A Number of days from study baseline to date of phase discontinuation Based on visit dates
Query ittpop_1 Integer Recommended Phase 1/1A ITT Population 0;1 intent-to-treat population: received at least one dose of study medication in this phase. Used for all efficacy analyses; 1=Yes, 0=No
Query comp_1 Integer Recommended Completed Phase 1 0;1 0=No; 1=Yes
Query comp_1a Integer Recommended Completed Phase 1A 0;1 0=No; 1=Yes
Query comp1_1a Integer Recommended Completed Phase 1 and 1A 0;1 0=No; 1=Yes
Query dcr1_1 Integer Recommended Primary Reason for Disc from Ph 1/1A 1::10 1 = Administrative Discontinuation; 2 = Inadequate Therapeutic Effect; 3 = Unacceptable Side Effects; 4 = Patient Decision; 5 = Subject Advocate Decision; 6 = Unavailable as of Database Cutoff;7= Patient Death , 8=Study Drug No longer Needed, 9= Study Drug was Not sufficiently Optimal, 10 = Worsening of Symptoms
Query dcr2_1 Integer Recommended Secondary Reason for Disc from Ph 1/1A 2;3 2 = Inadequate Therapeutic Effect; 3 = Unacceptable Side Effects
aedsc_1 String 250 Recommended Side Effect Led to Discont in Ph1/1A lists the side effect (primary or secondary)
Query rand_1b Integer Recommended Randomized in Phase 1B 0;1 0=No; 1=Yes
Query b1b_day Integer Recommended Baseline Day - Phase 1B Number of days from study baseline to first day of the phase Based on visit dates
Query e1b_day Integer Recommended Day Discontinued from Phase 1B Number of days from study baseline to date of phase discontinuation Based on visit dates
Query ittpop1b Integer Recommended Phase 1B ITT Population 0;1 intent-to-treat population: received at least one dose of study medication in this phase. Used for all efficacy analyses; 1=Yes, 0=No
Query comp_1b Integer Recommended Completed Phase 1B 0;1 0=No; 1=Yes
Query dcr1_1b Integer Recommended Primary Reason for Discontinuation from Ph 1B 1::6 1 = Administrative Discontinuation; 2 = Inadequate Therapeutic Effect; 3 = Unacceptable Side Effects; 4 = Patient Decision; 5 = Subject Advocate Decision; 6 = Unavailable as of Database Cutoff
Query dcr2_1b Integer Recommended Secondary Reason for Discontinuation from Ph 1B 2;3 2 = Inadequate Therapeutic Effect; 3 = Unacceptable Side Effects
Query aedsc_1b String 100 Recommended Side Effect Led to Discontinuation in Ph1B lists the side effect (primary or secondary)
Query rand_2e Integer Recommended Randomized in Phase 2E 0;1 0=No; 1=Yes
Query rand_2t Integer Recommended Randomized in Phase 2T 0;1 0=No; 1=Yes
Query rand2 Integer Recommended Randomized in Phase 2 0;1 0=No; 1=Yes
Query b2_day Integer Recommended Baseline Day - Phase 2 Number of days from study baseline to first day of the phase Based on visit dates
Query e2_day Integer Recommended Day Discontinued from Phase 2 Number of days from study baseline to date of phase discontinuation Based on visit dates
Query ittpop_2 Integer Recommended Phase 2E/2T ITT Population 0;1 intent-to-treat population: received at least one dose of study medication in this phase. Used for all efficacy analyses; 1=Yes, 0=No
Query comp_2e Integer Recommended Completed Phase 2E 0;1 0=No; 1=Yes
Query comp_2t Integer Recommended Completed Phase 2T 0;1 0=No; 1=Yes
Query comp2_et Integer Recommended Completed Phase 2E and 2T 0;1 1=Yes for patients who completed either Phase 2E or Phase 2T; 0 otherwise
Query dcr1_2 Integer Recommended Primary Reason for Disc from Ph 2 1::10 1 = Administrative Discontinuation; 2 = Inadequate Therapeutic Effect; 3 = Unacceptable Side Effects; 4 = Patient Decision; 5 = Subject Advocate Decision; 6 = Unavailable as of Database Cutoff;7= Patient Death , 8=Study Drug No longer Needed, 9= Study Drug was Not sufficiently Optimal, 10 = Worsening of Symptoms
Query dcr2_2 Integer Recommended Secondary Reason for Disc from Ph 2 2;3 2 = Inadequate Therapeutic Effect; 3 = Unacceptable Side Effects
aedsc_2 String 250 Recommended Side Effect Led to Discont in Ph2 lists the side effect (primary or secondary)
Query in_3 Integer Recommended In Phase 3 1 Indicator for entry in Phase 3: 1=Yes; missing otherwise
Query b3_day Integer Recommended Baseline Day - Phase 3 Number of days from study baseline to first day of the phase Based on visit dates
Query e3_day Integer Recommended Day Discontinued from Phase 3 Number of days from study baseline to date of phase discontinuation Based on visit dates
Query comp_3 Integer Recommended Completed Phase 3 0;1 0=No; 1=Yes
Query dcr1_3 Integer Recommended Primary Reason for Disc from Ph 3 1::10 1 = Administrative Discontinuation; 2 = Inadequate Therapeutic Effect; 3 = Unacceptable Side Effects; 4 = Patient Decision; 5 = Subject Advocate Decision; 6 = Unavailable as of Database Cutoff;7= Patient Death , 8=Study Drug No longer Needed, 9= Study Drug was Not sufficiently Optimal, 10 = Worsening of Symptoms
Query dcr2_3 Integer Recommended Secondary Reason for Disc from Ph 3 2;3 2 = Inadequate Therapeutic Effect; 3 = Unacceptable Side Effects
Query aedsc_3 String 250 Recommended Side Effect Led to Discont in Ph3 lists the side effect (primary or secondary)
Query phase1a Integer Recommended rand in Phase 1a (TD)1=yes,0=no 0;1 Identifies patients randomized into Phase 1A - the TD stratum which randomized patients equally to O, Q, R, or Z when it was added, but P was not an option. 1=yes, 0=no
Query treat_1 Integer Recommended Treatment for Phase 1 1::8 1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine;7= Citalopram; 8=Placebo
Query treat_1a Integer Recommended Treatment for Phase 1A 1::6 1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine
Query treat11a Integer Recommended Treatment for Phase 1/1A 1::6 1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine
Query zip_1 Integer Recommended Ziprasidone Available at Randomization? 0;1 Was Ziprasidone available as a randomized treatment when patient was randomized into Phase 1? 1=Yes, 0=No
Query zip_1a Integer Recommended Ziprasidone Available at Randomization? 0;1 Was Ziprasidone available as a randomized treatment when patient was randomized into Phase 1A? 1=Yes, 0=No
Query zpr_cort Integer Recommended Zipras Cohort: random aft ZPR added 1=y 0;1 0=No; 1=Yes
Query dose_1 Integer Recommended Randomized Dose for Phase 1 1;2 1=BID;2=QD
Query dose_1a Integer Recommended Randomized Dose for Phase 1A 1;2 1=BID;2=QD
Query randreg1 Integer Recommended P1 Randomized Dosing Regimen 1;2 Dosing regimen patient was randomized to 1= Once a Day (BID); 2= Twice a Day (QD)
Query treat_1b Integer Recommended Treatment for Phase 1B 1::6 1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine
Query dose_1b Integer Recommended Randomized Dose for Phase 1B 1;2 1=BID;2=QD
Query treat_2e Integer Recommended Treatment for Phase 2E 1::6 1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine
Query treat_2t Integer Recommended Treatment for Phase 2T 1::6 1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine
Query treat2 Integer Recommended Treatment for Phase 2E/2T 1::8 1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine; 7= Citalopram; 8=Placebo
Query zip_2e Integer Recommended Ziprasidone Available at Randomization? 0;1 Was Ziprasidone available as a randomized treatment when patient was randomized into Phase 2E? 1=Yes, 0=No
Query zip_2t Integer Recommended Ziprasidone Available at Randomization? 0;1 Was Ziprasidone available as a randomized treatment when patient was randomized into Phase 2T? 1=Yes, 0=No
Query ph2_arm Integer Recommended Phase 2 Cohort 1::3 1= Patient was randomized into Phase 2T prior to Ziprasidone being added to the protocol; 2= Patient was randomized into Phase 2T after Ziprasidone was added to the protocol; 3= Patient was randomized into Phase 2E
Query dose_2e Integer Recommended Randomized Dose for Phase 2E 1::3 1=BID;2=QD; 3=None
Query dose_2t Integer Recommended Randomized Dose for Phase 2T 1;2 1=BID;2=QD
Query randreg2 Integer Recommended P2 Randomized Dosing Regimen 1::3 Dosing regimen patient was randomized to 1= Once a Day (BID); 2= Twice a Day (QD); 3= None (for clozapine)
Query treat_31 Integer Recommended Treatment for Phase 3-First Drug Contains the first of 2 drugs that were assigned in Phase 3.Contains treatment assigned in Phase 3. 1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine; 7=Aripiprazole; 8=Fluphenazine; 9=Dual
Query treat_32 Integer Recommended Treatment for Phase 3- Second Drug Contains the second of 2 drugs that were assigned in Phase 3. If a patient was only assigned one drug in Phase 3, this variable is left blank. 1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine; 7=Aripiprazole; 8=Fluphenazine; 9=Dual
Query treat_3 Integer Recommended Treatment for Phase 3 (Combined) 1::9 Contains treatment assigned in Phase 3. If patient was only assigned one drug in this phase, the drug name is listed. If a patient was assigned 2 drugs in Phase 3, this variable takes the value of Dual.1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine; 7=Aripiprazole; 8=Fluphenazine; 9=Dual
Query set1 Integer Recommended Set1(OPQR): excl P1a(TD),Ziprasidone 0;1 0=No; 1=Yes
Query set2 Integer Recommended Set2(OQR): excl Perphenazine, Ziprasidone 0;1 0=No; 1=Yes
Query set3 Integer Recommended Set3(ZvsOQR): only ZPRcohort, excl Perph 0;1 0=No; 1=Yes
Query set4 Integer Recommended Set4(ZvsP) ex P1a(TD),only Zcort,ZPR,Perph 0;1 0=No; 1=Yes
Query action_1 Integer Recommended Action Taken After ending Phase 1 1;2;3;4 1=Moved to Next Randomized Phase; 2=Moved to Open Choice Phase; 3=Discontinued from the Study; 4=Unavailable as of Database Cutoff
Query comp_2 Integer Recommended Completed Phase 2 0;1 0=No; 1=Yes
Query action_2 Integer Recommended Action Taken After ending Phase 2 1;2;3;4 1=Moved to Next Randomized Phase; 2=Moved to Open Choice Phase; 3=Discontinued from the Study; 4=Unavailable as of Database Cutoff
Query action_3 Integer Recommended Action Taken After ending Phase 3 1;2;3;4 1=Moved to Next Randomized Phase; 2=Moved to Open Choice Phase; 3=Discontinued from the Study; 4=Unavailable as of Database Cutoff
Query comp_oc Integer Recommended Completed Open Choice Ph. 0;1 0=No; 1=Yes
Query aedsc_oc Integer Recommended Side Effect Led to Discontinuation in OC
Query dcr1_oc Integer Recommended Primary Reason for Disc from Open Choice 1;2;3;4;5;6;7;8;9;10 1 = ''Administrative Discontinuation''; 2 = ''Inadequate Therapeutic Effect''; 3 = ''Study Drug was not Sufficiently Optimal''; 4 = ''Worsening of Symptoms''; 5 = ''Unacceptable Side Effects''; 6 = ''Study Drug is no Longer Needed''; 7 = ''Patient Decision'' 8 = ''Caregiver Decision''; 9 = ''Patient Death''; 10 = ''Unavailable as of database Cutoff''
Query in_oc Integer Recommended In Open Choice Phase 0;1 0=No; 1=Yes
Query rand_3 Integer Recommended Randomized in Phase 3 0;1 0=No; 1=Yes
sitetype String 20 Recommended Site Care Setting Site care setting indicated by the site (all applicable types are listed per site); MC = Managed Care; PN = Private, Non-Profit Agency; PP = Private Practice; RO =Research Only;SH = State Mental Health;UC = University Clinic;VA = VA; MHIS = Mental health, isolation, or suicide watch; GP = General Population
Query care_st Integer Recommended Primary Care Setting 1;2;3 1=University; 2=Private Research; 3=VA
Query stdy_dur Integer Recommended Study Duration (days) Difference between study baseline date and end of study date
Query boc_day Integer Recommended Baseline Visit Day- Open Choice Phase Number of days from study baseline to start date of phase
Query eoc_day Integer Recommended Visit Day Discontinued from Open Choice Number of days from study baseline to end date of phase
Query treat3 Integer Recommended Treatment for Phase 2E/2T 1::8 1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine
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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