|
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_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.
|
|
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
|
|
sex |
String |
20
|
Required |
Sex of subject at birth |
M;F; O; NR
|
M = Male; F = Female; O=Other; NR = Not reported
|
gender |
Query
|
visitid |
Integer |
|
Recommended |
MetaTrial Visit ID |
|
System variable: unique code for each type of visit -use to merge files
|
|
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
|
Query
|
truncvis |
Integer |
|
Recommended |
Truncated Visit Number |
|
Created variable: provides a numeric visit number for all visits, including unscheduled and end of phase
|
|
Query
|
phase_ct |
String |
20
|
Recommended |
Current Phase. Phase patient was in at the time of the assessment Phase 4 refers to the follow-up phase. |
Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase; Screening; Phase 1
|
|
|
Query
|
visday |
Integer |
|
Recommended |
Number of days from study baseline to date of visit |
|
|
|
|
protocol |
String |
50
|
Recommended |
Protocol [Study] name |
|
|
|
Query
|
rtd01 |
Integer |
|
Recommended |
Day of phase discontinuation |
|
Number of days from study baseline to date of phase discontinuation
|
dayeop12, dayeop36 |
Query
|
rtd02 |
Integer |
|
Recommended |
Did pt successfully complete the medication |
0;1
|
0=No; 1=Yes, Skip to Section IV
|
|
Query
|
rtd03 |
Integer |
|
Recommended |
I.1 Administrative Discontinuation - Wer |
0;1
|
0=No;1= Yes
|
eop03 |
Query
|
rtd04 |
Integer |
|
Recommended |
II. Clinical Discontinuation |
0;1
|
0=No;1= Yes
|
eop04 |
Query
|
rtd05a |
Integer |
|
Recommended |
Inadequate therapeutic effect |
1;0
|
1=yes; 0=no
|
|
Query
|
rtd05b |
Integer |
|
Recommended |
Please choose |
1;2
|
1=Primary; 2=Secondary
|
|
Query
|
rtd05c |
Integer |
|
Recommended |
The problematc psychopatholgy was primarily |
1::4
|
1=Positive; 2=Negative; 3=Affective; 4=Other reason, specify
|
|
Query
|
rtd06a |
Integer |
|
Recommended |
Unacceptable side effects |
0;1
|
0=No;1= Yes
|
|
Query
|
rtd06b |
Integer |
|
Recommended |
Please choose |
1;2
|
1=Primary; 2=Secondary
|
|
Query
|
rtd06c |
Integer |
|
Recommended |
The most problematic side effect was |
1::4
|
1=Extrapyramidal; 2=Weight/Metabolic; 3=Sexual; 4=Other reason, specify
|
|
Query
|
rtd07a |
Integer |
|
Recommended |
Refusal/failure to take assigned antipsychotics |
0;1
|
0=No;1= Yes
|
|
Query
|
rtd07c |
Integer |
|
Recommended |
Is patient agereable with taking diffrent antipsychotics? |
0;1
|
0=No;1= Yes
|
|
Query
|
rtd08 |
Integer |
|
Recommended |
Patient withdrawn by subject advocate |
0;1
|
0=No;1= Yes
|
|
Query
|
rtd09 |
Integer |
|
Recommended |
Is the pt proceeding to the next medicat |
0;1
|
0=No;1= Yes
|
|
Query
|
rtd10 |
Integer |
|
Recommended |
Did a substance use disorder contribute |
0;1
|
0=No;1= Yes
|
|
Query
|
rtd11 |
Integer |
|
Recommended |
CLINICIAN: Which medication do you think was used |
1::5;95;99
|
1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 95=Refused to guess; 99=N/A On open-label Clozapine
|
|
Query
|
rtd12 |
Integer |
|
Recommended |
pt: Which medication do you think you were taken |
1::5;95;99
|
1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 95=Refused to guess; 99=N/A On open-label Clozapine
|
|
Query
|
rtd13 |
Integer |
|
Recommended |
Investigator signed end of phase source document |
0;1
|
0=No;1= Yes
|
|
Query
|
rtd14 |
Integer |
|
Recommended |
Investigator faxed end of phase source document |
0;1
|
0=No;1= Yes
|
|
Query
|
eop01 |
Integer |
|
Recommended |
What phase is the patient being discontinued from? |
1;2;3;4
|
1=1; 2=2; 3=3; 4=Open Choice
|
fhx10a |
Query
|
eop02a |
Integer |
|
Recommended |
Did the patient complete the full 36 weeks of study? |
0;1
|
0=No; 1=Yes
|
fhx10b |
Query
|
eop04a |
Integer |
|
Recommended |
Clinical Discontinuation: If yes, please state the reason |
1;2;3;4;5
|
1 = a. Inadequate therapeutic effect; 2 = b. Study drug was not sufficiently optim; 3 = c. Worsening of symptoms; 4 = d. Unacceptable side effects';' 5 = e. Study drug is no longer needed
|
|
Query
|
eop04b |
Integer |
|
Recommended |
II. Clinical Discontinuation: The most problematic side effect was: |
1;2;3;4;5;6;7
|
1 = Extrapyramidal; 2 = Weight gain; 3 = Weight loss; 4 = Falling; 5 = Syncope/dizziness/vertigo; 6 = Confusion; 7 = Other reason
|
|
Query
|
eop05 |
Integer |
|
Recommended |
Refusal/failure to take the assigned study drug |
0;1
|
0=No; 1=Yes
|
|
Query
|
eop05b |
Integer |
|
Recommended |
Patient Decision: Is the patient agreeable with taking a different study drug? |
0;1
|
0=No; 1=Yes
|
|
Query
|
eop06 |
Integer |
|
Recommended |
Caregiver's decision |
0;1
|
0=No; 1=Yes
|
|
Query
|
eop06b |
Integer |
|
Recommended |
Caregiver's Decision: Is the caregiver agreeable with the patient taking a different study drug? |
0;1
|
0=No; 1=Yes
|
|
Query
|
eop07 |
Integer |
|
Recommended |
Patient died during this study phase |
0;1
|
0=No; 1=Yes
|
|
Query
|
eop08 |
Integer |
|
Recommended |
What is the course of action for the patient? |
1;2;3
|
1 = Move to next randomized phase; 2 = Move to open-choice phase; 3 = Discontinued from the study*
|
|
Query
|
eop08a |
Integer |
|
Recommended |
Course of Action: What randomized phase proceeding to? |
2;3
|
2=2; 3=3
|
|
Query
|
eop09 |
Integer |
|
Recommended |
Has the investigator signed the End of Phase source document? |
0;1
|
0=No; 1=Yes
|
|
Query
|
eop02 |
Integer |
|
Recommended |
Day of phase discontinuation |
|
Number of days from study baseline to date of phase discontinuation
|
|
Query
|
eop10 |
Integer |
|
Recommended |
Investigators Signature Day signed: |
|
Number of days from study baseline to date investigator's signature was obtained
|
|
Query
|
eop07a |
Integer |
|
Recommended |
Patient Death: Day of patient death |
|
Number of days from study baseline to date of death
|
|
Query
|
daylast1vst |
Integer |
|
Recommended |
study day of last TREATMENT visit |
|
|
daylast2vst |
Query
|
complet1 |
Integer |
|
Recommended |
Did this child complete Phase TREATMENT PORTION of the study? |
0;1
|
0 = no; 1 = yes
|
complet2 |
Query
|
y1notdun |
Integer |
|
Recommended |
Which one of the following explains why the subject did not complete Phase |
1::4
|
1 = Study dropout; 2 = Treatment dropout; 3 = Premature termination; 4 = Other reason
|
y2notdun, y2notdun_d |
Query
|
lastp1wk |
Integer |
|
Recommended |
Week of last TREATMENT visit |
|
|
lastp2wk |
Query
|
camsresponse |
Integer |
|
Recommended |
TREATMENT RESPONSE from End of Phase Form |
1;2;3;4
|
1 = Active Treatment Responder;2 = Active Treatment Non-responder;3 = Placebo Responder;4 = Placebo Non-responder
|
|
Query
|
actvresp |
Integer |
|
Recommended |
Active Treatment responder: Does family agree to continue in maintenance treatment? |
0;1
|
0 = no; 1 = yes
|
|
Query
|
nomaintx |
String |
50
|
Recommended |
Active Treatment responder: Explain no maintenance treatment |
|
|
|
Query
|
actvnonr |
Integer |
|
Recommended |
Active Treatment non-responder: Does family agree to community referral? |
0;1
|
0 = no; 1 = yes
|
|
Query
|
nocomref |
String |
50
|
Recommended |
Active Treatment non-responder: Explain no community referral |
|
|
|
Query
|
pboresp |
Integer |
|
Recommended |
Placebo responder: Does family agrees to monthly maintenance visits and IE assessments? |
0;1
|
0 = no; 1 = yes
|
|
|
nostoptx |
String |
50
|
Recommended |
Placebo responder: Explain no maintenance and IE assessments |
|
|
|
Query
|
openlabl |
Integer |
|
Recommended |
Placebo non-responder: Does family agree to Open-label CAMS Treatment? |
0;1
|
0 = no; 1 = yes
|
|
Query
|
treatment_name |
String |
200
|
Recommended |
treatment name |
|
|
|
Query
|
noopnlbl |
String |
50
|
Recommended |
Placebo non-responder: Explain no Open Label |
|
|
|
Query
|
faz1done |
Integer |
|
Recommended |
Did child complete Phase Assessments? |
0;1
|
0 = no; 1 = yes
|
faz2done |
Query
|
completed |
Integer |
|
Recommended |
Checks if completed |
0::3
|
0=No; 1=Yes; 2=Yes, lost; 3=Unverified
|
wk4 |
Query
|
wkasscomp |
Integer |
|
Recommended |
Study Week Assessment Completed |
|
|
|
Query
|
faz2asmt |
Integer |
|
Recommended |
Does the family agree to continue with Phase II Assessments? |
0;1
|
0 = no; 1 = yes
|
|
|
comments_misc |
String |
4,000
|
Recommended |
Miscellaneous comments on study, interview, methodology relevant to this form data |
|
|
ynofaz2 |
Query
|
discontinuation_reason1 |
String |
250
|
Recommended |
Discontinuation Reason: |
|
|
otheresn |
Query
|
otheresn_d |
Integer |
|
Recommended |
Other Reason Derived |
1::5
|
1::5
|
|
Query
|
final_r_pd |
Integer |
|
Recommended |
Remission Psychotic Depression: Remission was defined as a HAM-D 17 item score of 10 or lower at 2 consecutive assessments. Remission also required the absence of delusions (SADS delusional item score of 1) at the second remission of depression assessment. Subjects who were not delusional at both of 2 consecutive HAM-D assessments were considered remitted at both points; subjects who had been delusional at the first of the HAM-D assessments were considered to be remitted at the second assessment only, and subjects who were not delusional at the first assessment but had SADS scores higher than 1 at the second were classified as not remitted at either assessment. Subjects who achieved a HAM-D score of 10 or lower without delusions for the first time at week 12 were assessed again at week 13 to determine whether the 2-week duration criterion was met. |
0;1
|
0 = no; 1 = yes
|
|
Query
|
lastvisit |
Integer |
|
Recommended |
This variable indicates whether the assessment was the last for the subject. For the acute phase, this is generally at week 12, but the last weekly visit will vary for early terminators. |
0;1
|
0 = no; 1 = yes
|
|
Query
|
outcome_text |
String |
100
|
Recommended |
Outcome Text |
|
|
|
Query
|
outcome_id |
Integer |
|
Recommended |
Outcome Code |
2::42
|
2 = Dropped Medical Reasons - Side Effects; 3 = Dropped Medical Reasons - Inter-current Events; 7 = No Longer Meets Study Criteria; 14 = Completed Study; 20 = Other; 21 = Death - non-suicide; 22 = Suicide attempt or increased suicidality; 23 = Worsening depression; 24 = Lost to follow-up; 25 = Patient moved - distance; 26 = Worsening psychosis; 27 = Worsening depression and psychosis; 28 = Other emergent psychiatric symptoms; 29 = Patient Perception: Clinical improvement; 30 = Completed suicide attempt; 34 = Patient perception: Ineffective treatment; 35 = Patient changed mind about participation in research; 36 = Patient's family opposed to his/her study participation; 37 = Patient refused further study med treatment (not due to side effects); 38 = Problems with transportation; 39 = Protocol violation; 41 = Inappropriate for research participation; 42 = Insufficient therapeutic response
|
|
Query
|
outcomedays |
Integer |
|
Recommended |
Outcome Days from Baseline |
|
|
|
Query
|
statusa |
Integer |
|
Recommended |
What was the outcome of the Acute Phase? |
1::3
|
1 = Met Full Remission criteria; 2 = Met Partial Remission criteria; 3 = Non-remitted; 4 = Randomized then exited
|
|
Query
|
stabyesno |
Integer |
|
Recommended |
For Partial and Full Remitters at 12 weeks: Will patient enter Stabilization Phase? |
0;1
|
0 = no; 1 = yes
|
|
Query
|
nostabexplain |
String |
500
|
Recommended |
Explain not going into Stabilization |
|
|
|
Query
|
study_id |
Integer |
|
Recommended |
Study ID number |
|
46=Acute Phase; 47=Stabilization Phase
|
|
Query
|
inttimewk |
Integer |
|
Recommended |
Week of study: Initial |
|
-2 = pre-baseline (2 weeks); -1 = pre-baseline (1 week); 0 = baseline; 1 = week 1; 12 = week 12; 13 = week 13; 14 = week 14
|
|
Query
|
week |
Float |
|
Recommended |
Week in level/study |
|
99=week 10-week 14
|
intid |
Query
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
|
Query
|
statuss |
Integer |
|
Recommended |
What was the outcome of the Stabilization Phase? |
1::4
|
1 = Met Full Remission criteria; 2 = Met Partial Remission criteria; 3 = Relapse; 4 = Significant Clinical Worsening
|
|
Query
|
responsible |
Integer |
|
Recommended |
If outcome is Early Termination, who was the primary person responsible for the early termination? |
1::5
|
1 = Patient; 2 = Study Investigator; 3 = Physician at institution- not involved in study; 4 = Physician outside institution (e.g., Primary care physician); 5 = Family member or significant other
|
|