|
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 |
|
|
id, subject_id, subjectid |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
date_eligibility_healthy, date_pt_eligible, visit_date |
|
interview_age |
Integer |
|
Required |
Age in months at the time of the interview/test/sampling/imaging. |
0::1440
|
Age is rounded to chronological month. If the research participant is 15-days-old at time of interview, the appropriate value would be 0 months. If the participant is 16-days-old, the value would be 1 month.
|
elig_incl_age |
|
sex |
String |
20
|
Required |
Sex of subject at birth |
M;F; O; NR
|
M = Male; F = Female; O=Other; NR = Not reported
|
gender |
Query
|
elig_version_form |
Integer |
|
Recommended |
Form version |
1::3
|
1=Clinical; 2=Healthy control; 3=Incl/Excl
|
|
Query
|
beh_session_complete |
Integer |
|
Recommended |
Checks for complete BEH session |
0;1
|
0=No; 1=Yes
|
elig_beh_session_hc |
Query
|
chf_entered |
Integer |
|
Recommended |
Clinical History Form completion |
0;1
|
0=No; 1=Yes
|
elig_eeg_session_hc |
Query
|
rev_headeeg |
String |
50
|
Recommended |
EEG |
|
NK= Not known; NS = Not sure
|
eeg_session_complete, elig_inclusion_check_hc |
Query
|
elig_inclusion_check |
Integer |
|
Recommended |
Checks for a pass/fail on Elig for Inclusion |
0::3
|
0=Failed (Ineligible); 1=Passed (Eligible); 2=In screening; 3=NA
|
elig_mri_session_hc, eligible, healthy_eligibile |
Query
|
elig_r_5 |
Integer |
|
Recommended |
Checks if QIDS score is >= to 14 |
0;1;9
|
0=No; 1=Yes; 9=N/A
|
|
|
elig_r_blood |
Date |
|
Recommended |
Date of blood samples collection |
|
|
elig_r_blood_hc |
Query
|
elig_r_blood_tube |
Integer |
|
Recommended |
Checks blood collection - number of tubes |
|
|
elig_r_blood_tube_hc |
|
elig_r_eeg |
Date |
|
Recommended |
Date of successful data transfer EEG sessions |
|
|
elig_r_eeg_hc |
|
elig_r_mri |
Date |
|
Recommended |
Date of MRI data transfer |
|
|
elig_r_mri_hc |
|
elig_r_pheno |
Date |
|
Recommended |
Date of successful data transfer phenotype sessions |
|
|
elig_r_pheno_hc |
|
elig_r_qids_eeg_date |
String |
50
|
Recommended |
QIDS EEG date/time |
|
|
|
Query
|
qids_eeg_total |
Float |
|
Recommended |
QIDS EEG Total Score |
|
|
elig_r_qids_eeg_score |
|
elig_r_qids_eval_date |
String |
50
|
Recommended |
QIDS EVAL date/time |
|
|
|
|
elig_r_qids_rand_date |
String |
50
|
Recommended |
QIDS RAND date/time |
|
|
|
Query
|
qstot |
Float |
|
Recommended |
QIDS total score |
|
|
elig_qids_eval_score, elig_qids_hc, elig_r_qids_rand_score, qids_sr_score_random, qidssr_from_screening, qidssr_from_screening_hc |
Query
|
eligrnd_dysthymia_threshold |
Integer |
|
Recommended |
Dysthymia threshold |
0;1
|
0=No; 1=Yes
|
|
Query
|
eligrnd_mdd_threshold |
Integer |
|
Recommended |
MDD variable to indicate randomization |
0;1
|
0=No; 1=Yes
|
|
Query
|
hamd_score |
Float |
|
Recommended |
Pulls in score from HAM-D |
|
|
hamd_score_24 |
Query
|
hamd_severity |
Integer |
|
Recommended |
message on severity |
0::2
|
0=N/A; 1=High severity (>=20); 2=Low severity (<20)
|
|
Query
|
mri_session_complete |
Integer |
|
Recommended |
Checks for complete MRI session |
0;1
|
0=No; 1=Yes
|
|
Query
|
sample_group |
Integer |
|
Recommended |
Sample group selection |
1;2
|
1=Clinical; 2=Healthy control
|
elig_sample_hc, sample_group_hc |
Query
|
scid_chron_indication |
Integer |
|
Recommended |
message on chronicity |
0::2
|
0=N/A; 1=Chronic (4-6); 2=Non chronic (1-3)
|
|
|
scid_chron_rnd |
String |
20
|
Recommended |
Pulls in SCID question 10f |
|
|
|
Query
|
screening_status |
Integer |
|
Recommended |
Message box that indicates status for randomization |
1::3
|
1=In screening; 2=Not eligible for randomization; 3=Eligible for randomization
|
|
Query
|
stg2_form_complete |
Integer |
|
Recommended |
Check Eligibility Stage 2 completed |
0;1;9
|
0=No; 1=Yes; 9=N/A
|
|
Query
|
ptcon |
Integer |
|
Recommended |
Patient consented |
|
0=No; 1=Yes
|
consented, elig_1, elig_consent_hc, icfsubj, inconc |
Query
|
elig_10 |
Integer |
|
Recommended |
Current primary diagnosis of OCD |
0;1
|
0=No; 1=Yes
|
exocd |
Query
|
elig_11 |
Integer |
|
Recommended |
Current substance dependence |
0;1
|
0=No; 1=Yes
|
elig_substance, exdetox |
Query
|
exdtx |
Integer |
|
Recommended |
EX: needs hospitalization for detox |
0;1
|
0=No; 1=Yes
|
elig_12, elig_hospital_psycho |
Query
|
elig_13 |
Integer |
|
Recommended |
Have unstable GMC |
0;1
|
0=No; 1=Yes
|
elig_unstable_gmc |
Query
|
elig_14 |
Integer |
|
Recommended |
Meds for GMC |
0;1
|
0=No; 1=Yes
|
elig_meds_gmc |
Query
|
elig_15 |
Integer |
|
Recommended |
Epilepsy |
0;1
|
0=No; 1=Yes
|
elig_epilepsy |
Query
|
elig_16 |
Integer |
|
Recommended |
Receive somatic treatment |
0;1
|
0=No; 1=Yes
|
|
Query
|
elig_17 |
Integer |
|
Recommended |
Currently taking exclusionary meds |
0;1
|
0=No; 1=Yes
|
elig_exclusion_meds |
Query
|
elig_18 |
Integer |
|
Recommended |
Liver disease |
0;1
|
0=No; 1=Yes
|
|
Query
|
elig_19 |
Integer |
|
Recommended |
Thyroid meds |
0;1
|
0=No; 1=Yes
|
elig_thyroid_meds, exthyroi |
Query
|
elig_2 |
Integer |
|
Recommended |
Current diagnosis of MDD |
0;1
|
0=No; 1=Yes
|
|
Query
|
elig_20 |
Integer |
|
Recommended |
Augmenting Agents |
0;1
|
0=No; 1=Yes
|
exagents |
Query
|
elig_21 |
Integer |
|
Recommended |
Therapy |
0;1
|
0=No; 1=Yes
|
|
Query
|
elig_22 |
Integer |
|
Recommended |
English fluency |
0;1
|
0=No; 1=Yes
|
elig_fluency |
Query
|
elig_23 |
Integer |
|
Recommended |
Suicidal |
0;1
|
0=No; 1=Yes
|
elig_suicidal |
Query
|
elig_24 |
Integer |
|
Recommended |
Alternate study |
0;1
|
0=No; 1=Yes
|
|
Query
|
elig_25 |
Integer |
|
Recommended |
Non listed reason |
0;1
|
0=No; 1=Yes
|
elig_nonlisted |
Query
|
elig_27 |
Integer |
|
Recommended |
Clinically abnormal lab results |
0;1;9
|
1 = Yes; 0 = No; 9 = Unknown
|
elig_abnorm_labs |
Query
|
elig_4 |
Integer |
|
Recommended |
Antidepressant trials |
0;1
|
0=No; 1=Yes
|
|
Query
|
elig_5 |
Integer |
|
Recommended |
Biomarkers |
0;1
|
0=No; 1=Yes
|
elig_biomarkers |
Query
|
elig_6 |
Integer |
|
Recommended |
History of inadequate response |
0;1
|
0=No; 1=Yes
|
|
Query
|
exprg |
Integer |
|
Recommended |
EX: pregnancy |
0;1
|
0=No; 1=Yes
|
elig_7, elig_pregnancy |
Query
|
elig_8 |
Integer |
|
Recommended |
Plan to be pregnant |
0;1
|
0=No; 1=Yes
|
expreg |
Query
|
elig_9 |
Integer |
|
Recommended |
History of psychotic disorders |
0;1
|
0=No; 1=Yes
|
elig_psycho_disor |
Query
|
elig_dysthymia |
Integer |
|
Recommended |
Eligibility variable for dysthymia |
0::2
|
0=No; 1=Yes; 2=Unknown
|
|
Query
|
elig_ecg_1 |
Integer |
|
Recommended |
Checks if subject is over 60 |
0;1
|
0=No; 1=Yes
|
|
Query
|
elig_ecg_2 |
Integer |
|
Recommended |
Checks for ECG |
0;1
|
0=No; 1=Yes
|
|
Query
|
elig_metal_screen |
Integer |
|
Recommended |
pulls in metal screen pass/fail |
0;1
|
0=Fail; 1=Pass
|
elig_metal_hc |
Query
|
elig_scid_1 |
Integer |
|
Recommended |
Onset of MDE <=30 |
0;1
|
0=No; 1=Yes
|
|
Query
|
elig_scid_2 |
Integer |
|
Recommended |
MDD duration meets Eligibility |
0;1
|
0=No; 1=Yes
|
|
Query
|
elig_alternate_study_hc |
Integer |
|
Recommended |
Checks if in alternate study |
0;1
|
0=No; 1=Yes
|
|
Query
|
elig_dsm |
Integer |
|
Recommended |
No past or present DSM-IV Axis I disorder |
0;1
|
0=No; 1=Yes
|
|
|
elig_qids_score_hc_display |
String |
30
|
Recommended |
display for qids HC eval |
|
|
|
Query
|
stg2_anorex |
Integer |
|
Recommended |
Checks for Anorexia |
0;1;9
|
0=No; 1=Yes; 9=N/A
|
|
Query
|
stg2_bulimia |
Integer |
|
Recommended |
Checks for Bulimia |
0;1;9
|
0=No; 1=Yes; 9=N/A
|
|
Query
|
stg2_seizure |
Integer |
|
Recommended |
Checks for Seizure risk |
0;1;9
|
0=No; 1=Yes; 9=N/A
|
|
|
subject_description |
String |
4,000
|
Recommended |
Subject related information (e.g the affection, phenotype, disease information, etc.). |
|
|
|
Query
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
site_uid |
|
session_id |
String |
20
|
Recommended |
session ID/screening ID |
|
|
screeningid |
|
version_form |
String |
121
|
Recommended |
Form used/assessment name |
|
|
form_name, formid, version_ic_signed |
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
time, visit_name |
Query
|
elgrr |
Integer |
|
Recommended |
Subject passed independent rater review |
1;2
|
1=Yes; 2=No
|
|
Query
|
elgmmapp |
Integer |
|
Recommended |
Medical Monitor approved subject for randomization |
1;2
|
1=Yes; 2=No
|
|
Query
|
elgmdrs |
Integer |
|
Recommended |
Baseline MADRS in eligible range |
1;2
|
1=Yes; 2=No
|
|
Query
|
elgsibq |
Integer |
|
Recommended |
Baseline SIBQ clear of Suicidal Ideation Behavior |
1;2
|
1=Yes; 2=No
|
|
Query
|
elgadstb |
Integer |
|
Recommended |
Current pharmacotherapy stable |
1;2
|
1=Yes; 2=No
|
|
Query
|
elgadprt |
String |
50
|
Recommended |
Prescribed anti-depressant |
|
|
|
Query
|
elgadoth |
String |
50
|
Recommended |
Other prescribed anti-depressants |
|
|
|
Query
|
elgwsh |
Integer |
|
Recommended |
Prohibited pharmacotherapy wash out |
1;2;999
|
1=Yes; 2=No; 999=N/A
|
|
Query
|
ecbmi |
Integer |
|
Recommended |
Subject baseline weight recorded and BMI 18-35 |
1;2
|
1=Yes; 2=No
|
|
|
icfdat |
Date |
|
Recommended |
ICF Received Date |
|
|
ic_signed_date |
Query
|
elgrcvcf |
Integer |
|
Recommended |
Subject received signed dated copy of consent form |
1;2
|
1=Yes; 2=No
|
|
Query
|
subjelgb |
Integer |
|
Recommended |
Subject satisfies all eligibility criteria |
1;2
|
1=Yes; 2=No
|
eligibility |
|
sign_button |
String |
10
|
Recommended |
Patient Eligibility Sign Off by PI |
|
|
date_pi_sign_off |
|
study |
String |
100
|
Recommended |
Study; The code for each individual study |
|
|
|
Query
|
week |
Float |
|
Recommended |
Week in level/study |
|
99=week 10-week 14
|
|
Query
|
days_baseline |
Integer |
|
Recommended |
Days since baseline |
|
|
date |
Query
|
vis_type |
Integer |
|
Recommended |
Visit type |
0::2
|
1=Phone/remote; 0=doctor's office/In person; 2=No, not phone interview
|
phone |
Query
|
incare |
Integer |
|
Recommended |
Enrolled at primary or specialty site |
0;1
|
0=No; 1=Yes
|
|
Query
|
inage |
Integer |
|
Recommended |
IN: age 18-75 |
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
|
|
Query
|
inhrd |
Integer |
|
Recommended |
IN: HRS-D score 14 or higher |
0;1
|
0=No; 1=Yes
|
|
Query
|
indepmed |
Integer |
|
Recommended |
Antidepressant med is acceptable |
0;1
|
0=No; 1=Yes
|
|
Query
|
insuic |
Integer |
|
Recommended |
Treatment clinically appropriate |
0;1
|
0=No; 1=Yes
|
|
Query
|
exbreast |
Integer |
|
Recommended |
Pregnant or breastfeeding |
0;1;-99
|
0=No; 1=Yes; -99 = Missing
|
|
Query
|
exlife |
Integer |
|
Recommended |
Lifetime of Axis I disorder |
0;1
|
0=No; 1=Yes
|
|
Query
|
expsych |
Integer |
|
Recommended |
Current psychotic symptoms |
0;1
|
0=No; 1=Yes
|
|
Query
|
exanorex |
Integer |
|
Recommended |
Anorexia or bulimia last 2 years |
0;1
|
0=No; 1=Yes
|
|
Query
|
exhosp |
Integer |
|
Recommended |
Requires hospitalization for psych disorder |
0;1
|
0=No; 1=Yes
|
|
Query
|
exallerg |
Integer |
|
Recommended |
History of allergy to protocol meds |
0;1
|
0=No; 1=Yes
|
|
Query
|
exnonfda |
Integer |
|
Recommended |
Nonresponse to adequate FDA trial: current |
0;1
|
0=No; 1=Yes
|
|
Query
|
exnoncit |
Integer |
|
Recommended |
Nonresponse to trial of protocol drugs |
0;1
|
0=No; 1=Yes
|
|
Query
|
exstumed |
Integer |
|
Recommended |
Currently taking study medication |
0;1
|
0=No; 1=Yes
|
|
Query
|
exmaoi |
Integer |
|
Recommended |
Taken prozac or MAOI last 2 weeks |
0;1
|
0=No; 1=Yes
|
|
Query
|
exgmchos |
Integer |
|
Recommended |
Has GMC might require hospitalization |
0;1
|
0=No; 1=Yes
|
|
Query
|
extakmed |
Integer |
|
Recommended |
Current meds contraindicate study meds |
0;1
|
0=No; 1=Yes
|
|
Query
|
exreqmed |
Integer |
|
Recommended |
Require meds that contraindicate study meds |
0;1
|
0=No; 1=Yes
|
|
Query
|
exreqant |
Integer |
|
Recommended |
Condition requiring anticonvulsant |
0;1
|
0=No; 1=Yes
|
|
Query
|
exseiz |
Integer |
|
Recommended |
History of having a seizure |
0;1
|
0=No; 1=Yes
|
|
Query
|
exstim |
Integer |
|
Recommended |
Have received somatic antidepressant treatment |
0;1
|
0=No; 1=Yes
|
|
Query
|
ex30med |
Integer |
|
Recommended |
Have taken exclusionary meds last 30 days |
0;1
|
0=No; 1=Yes
|
|
Query
|
expsycho |
Integer |
|
Recommended |
Antidepressant med for MDD or other purposes |
0;1
|
0=No; 1=Yes
|
|
Query
|
exglauc |
Integer |
|
Recommended |
Uncontrolled narrow-angle glaucoma |
0;1
|
0=No; 1=Yes
|
|
Query
|
exthera |
Integer |
|
Recommended |
Therapy that is depression specific |
0;1
|
0=No; 1=Yes
|
|
Query
|
exflaked |
Integer |
|
Recommended |
Changed mind about study after starting forms |
0;1
|
0=No; 1=Yes
|
|
|
date_updated |
Date |
|
Recommended |
Date record updated |
|
|
edit_date |
Query
|
time_pt |
Integer |
|
Recommended |
Collection time point (weeks) |
0::52
|
0=baseline
|
tpid |
Query
|
rand_num |
Integer |
|
Recommended |
Randomization Number |
0::2
|
|
|
Query
|
call_num |
Integer |
|
Recommended |
Site Eligibility Call Number for a Given Day |
1::99
|
|
|
Query
|
se_symptom |
String |
3
|
Recommended |
Active psychotic symptom of moderateseverity |
0;1
|
1=yes; 0=no
|
|
Query
|
se_age |
String |
3
|
Recommended |
Age 8 - 19 years |
0;1
|
1=yes; 0=no
|
|
Query
|
se_iq |
String |
3
|
Recommended |
IQ > 65 |
0;1
|
1=yes; 0=no
|
|
Query
|
se_diagnosis |
String |
3
|
Recommended |
Diagnosis of a PDD or ASQ score >= 15 |
0;1
|
1=yes; 0=no
|
|
Query
|
se_schizo |
String |
3
|
Recommended |
Meets criteria for schizophrenia, Schizophreniform, schizoaffective |
0;1
|
1=yes; 0=no
|
|
Query
|
se_priorhist |
String |
3
|
Recommended |
Prior history of suicide attemps or serious violence |
0;1
|
1=yes; 0=no
|
|
Query
|
se_endocrin |
String |
3
|
Recommended |
Endocrinology or neurologic illness |
0;1
|
1=yes; 0=no
|
|
Query
|
se_suicide |
String |
3
|
Recommended |
Serious acute risk for suicide |
0;1
|
1=yes; 0=no
|
|
Query
|
se_contracep |
String |
3
|
Recommended |
Willing to practice contraception |
0;1
|
1=yes; 0=no
|
|
Query
|
se_depot |
String |
3
|
Recommended |
Depot antipsychotics within past 6 months |
0;1
|
1=yes; 0=no
|
|
Query
|
se_molind |
String |
3
|
Recommended |
Use molindone during current episode |
0;1
|
1=yes; 0=no
|
|
Query
|
se_molinda |
String |
3
|
Recommended |
Use molindone--dose >= 140mg |
0;1
|
1=yes; 0=no
|
|
Query
|
se_molindb |
String |
3
|
Recommended |
Use molindone--duration of treatment >= 8 weeks |
0;1
|
1=yes; 0=no
|
|
Query
|
se_molindc |
String |
3
|
Recommended |
Use molindone--dose >= 140mg and duration >= 2 weeks |
0;1
|
1=yes; 0=no
|
|
Query
|
se_olana |
String |
3
|
Recommended |
Use olanzapine |
0;1
|
1=yes; 0=no
|
|
Query
|
se_olanaa |
String |
3
|
Recommended |
Use olanzapine--Dose >= 20 mg |
0;1
|
1=yes; 0=no
|
|
Query
|
se_olanab |
String |
3
|
Recommended |
Use olanzapine--duration of treatment >=8 weeks |
0;1
|
1=yes; 0=no
|
|
Query
|
se_olanac |
String |
3
|
Recommended |
Use olanzapine--dose >= 20 mg and duration >= 2 weeks |
0;1
|
1=yes; 0=no
|
|
Query
|
se_risper |
String |
3
|
Recommended |
Use risperidone |
0;1
|
1=yes; 0=no
|
|
Query
|
se_rispera |
String |
3
|
Recommended |
Use risperidone--Dose >= 6mg |
0;1
|
1=yes; 0=no
|
|
Query
|
se_risperb |
String |
3
|
Recommended |
Use risperidone--duration of treatment >=8 weeks |
0;1
|
1=yes; 0=no
|
|
Query
|
se_risperc |
String |
3
|
Recommended |
Use risperidone--dose >= 6mg |
0;1
|
1=yes; 0=no
|
|
Query
|
se_allergy |
String |
3
|
Recommended |
Allergy to molindone |
0;1
|
1=yes; 0=no
|
|
Query
|
se_epse |
String |
3
|
Recommended |
Severe EPSE or NMS |
0;1
|
1=yes; 0=no
|
|
Query
|
se_blood |
String |
3
|
Recommended |
Persistent significant blood chemistry abnormalities |
0;1
|
1=yes; 0=no
|
|
Query
|
se_moodst |
String |
3
|
Recommended |
Use of antidepressant or mood stabilizer |
0;1
|
1=yes; 0=no
|
|
Query
|
se_stab30 |
String |
3
|
Recommended |
Use of antidepressant or mood stabilizer. If yes, has the dose been stable for 30 days |
0;1
|
1=yes; 0=no
|
|
Query
|
se_majdep |
String |
3
|
Recommended |
Experiencing major depressive episode |
0;1
|
1=yes; 0=no
|
|
|
se_nocons |
String |
25
|
Recommended |
Why Consent Form was Not Signed |
|
Actual
|
reason_other |
Query
|
daysrz |
Integer |
|
Recommended |
days since randomization |
|
|
|
|
time_ic_signed |
String |
5
|
Recommended |
Time Informed Consent Signed? |
|
HH:MM
|
|
Query
|
elig_criteria |
Integer |
|
Recommended |
Did patient meet all eligibility criteria? |
1::4
|
1 = Yes 2 = No (waiver) 3 = No (excluded) 4 = Unsure
|
|
|
lab020 |
Date |
|
Recommended |
Date of PI/clinician signature |
|
|
healthy_eligibilty_pi_sign |
Query
|
inclusion_bdd_a |
Integer |
|
Recommended |
Inclusion Criteria: Able to give voluntary informed consent |
0;1
|
0= Unchecked; 1= Checked
|
inclusion_healthy_a |
Query
|
inclusion_bdd_e |
Integer |
|
Recommended |
Inclusion Criteria: No psychotropics in the last 2 weeks (if previously on fluoxetine then medication free for 5 weeks |
0;1
|
0= Unchecked; 1= Checked
|
inclusion_healthy_e |
Query
|
inclusion_bdd_f |
Integer |
|
Recommended |
Inclusion Criteria: No lithium treatment for past 6 months |
0;1
|
0= Unchecked; 1= Checked
|
inclusion_healthy_f |
Query
|
inclusion_bdd_h |
Integer |
|
Recommended |
Inclusion Criteria: Willing to complete the MRI scan and provide RNA sample at baseline |
0;1
|
0= Unchecked; 1= Checked
|
inclusion_healthy_h |
Query
|
inclusion_bdd_g |
Integer |
|
Recommended |
Inclusion Criteria: Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire; 8) able to be managed as outpatients during the study as ascertained by Clinical Global Severity Scale < 5 (i.e.= moderately ill) and no significant suicidal or homicidal ideation or gross disability |
0;1
|
0= Unchecked; 1= Checked
|
|
Query
|
exclusion_bdd_b |
Integer |
|
Recommended |
Exclusion Criteria: Requiring inpatient treatment |
0;1
|
0= Unchecked; 1= Checked
|
exclusion_healthy_b |
Query
|
exclusion_bdd_d |
Integer |
|
Recommended |
Exclusion Criteria: Positive urinary toxicology screening at baseline |
0;1
|
0= Unchecked; 1= Checked
|
exclusion_healthy_d |
Query
|
exclusion_bdd_e |
Integer |
|
Recommended |
Exclusion Criteria: Use of alcohol in the past 1 week |
0;1
|
0= Unchecked; 1= Checked
|
exclusion_healthy_e |
Query
|
exclusion_bdd_f |
Integer |
|
Recommended |
Exclusion Criteria: Serious medical or neurological illness |
0;1
|
0= Unchecked; 1= Checked
|
exclusion_healthy_f |
Query
|
reconsent |
Integer |
|
Recommended |
Is this a reconsent? |
0;1
|
0= No; 1= Yes
|
|
Query
|
inclusion_bdd_b |
Integer |
|
Recommended |
Inclusion Criteria: Satisfy criteria for Diagnostic and Statistical Manual 5th edition (DSM-V) for BD type II or I= current Depressive Episode |
0;1
|
0= Unchecked; 1= Checked
|
inclusion_healthy_b |
Query
|
inclusion_bdd_c |
Integer |
|
Recommended |
Inclusion Criteria: 17-item Hamilton Depression Rating Scale (HAM-D) score >15 and < 25 |
0;1
|
0= Unchecked; 1= Checked
|
inclusion_healthy_c |
Query
|
inclusion_bdd_d |
Integer |
|
Recommended |
Inclusion Criteria: Young Mania Rating Scale (YMRS) < 8 |
0;1
|
0= Unchecked; 1= Checked
|
inclusion_healthy_d |
Query
|
exclusion_bdd_a |
Integer |
|
Recommended |
Exclusion Criteria: Meeting DSM-IV criteria for schizophrenia= schizoaffective disorder= or an anxiety disorder as a primary diagnosis |
0;1
|
0= Unchecked; 1= Checked
|
exclusion_healthy_a |
Query
|
exclusion_bdd_c |
Integer |
|
Recommended |
Exclusion Criteria: Meeting DSM-V criteria for substance dependence within the past year= except caffeine or nicotine |
0;1
|
0= Unchecked; 1= Checked
|
exclusion_healthy_c |
Query
|
exclusion_bdd_g |
Integer |
|
Recommended |
Exclusion Criteria: Current pregnancy or breast feeding |
0;1
|
0= Unchecked; 1= Checked
|
exclusion_healthy_g |
Query
|
exclusion_bdd_h |
Integer |
|
Recommended |
Exclusion Criteria: Metallic implants or other contraindications to MRI |
0;1; 888
|
0= Unchecked; 1= Checked; 888 = Not assessed - patient was ineligible
|
exclusion_healthy_h |
|
ccc2datecomp |
Date |
|
Recommended |
Date Completed |
|
|
date_pt_eligible |
|
faec01 |
Integer |
|
Recommended |
Presence of symptomatic ataxic disease |
0;1
|
0=No; 1=Yes
|
|
|
faec02 |
Integer |
|
Recommended |
Person who is premanifest or at risk for SCA1 or SCA3 with no symptoms |
0;1
|
0=No; 1=Yes
|
|
|
faec03 |
Integer |
|
Recommended |
Definite molecular diagnosis of SCA 1 or 3 either in the subject or another affected family member |
0;1
|
0=No; 1=Yes
|
|
|
faec04 |
Integer |
|
Recommended |
Willingness to participate in the study and ability to give informed consent |
0;1
|
0=No; 1=Yes
|
|
|
faec05 |
Integer |
|
Recommended |
Age criteria met (has to be yes for specific category): If symptomatic (SARA ? 3) ages 18-65 years |
0;1
|
0=No; 1=Yes
|
|
|
faec06 |
Integer |
|
Recommended |
Age criteria met (has to be yes for specific category): If premanifest (SARA ? 2.5) ages 27-65 years |
0;1
|
0=No; 1=Yes
|
|
|
faec07 |
Integer |
|
Recommended |
Age criteria met (has to be yes for specific category): If at risk (SARA ? 2.5) ages 27-50 years |
0;1
|
0=No; 1=Yes
|
|
|
faec08 |
Integer |
|
Recommended |
Age criteria met (has to be yes for specific category): If past participant, any age |
0;1
|
0=No; 1=Yes
|
|
|
faec09 |
Integer |
|
Recommended |
SARA score (one of the following must be yes): Past participant: SARA score ? 9.5 at last visit of prior study (it can be higher now) |
0;1
|
0=No; 1=Yes
|
|
|
faec10 |
Integer |
|
Recommended |
SARA score (one of the following must be yes): New participant to U01: SARA score ? 9.6 |
0;1
|
0=No; 1=Yes
|
|
|
faec11 |
Integer |
|
Recommended |
Changes in physical/occupational therapy status have not occurred for 2 months prior to enrollment |
0;1
|
0=No; 1=Yes
|
|
|
exc4prioruseofinvsdrug |
Integer |
|
Recommended |
Exclusion 4 Use of investigational drugs in 2 months prior to enrollment |
0;1
|
1=Yes; 0=No
|
|
|
sca1repeatsnormalallele |
Integer |
|
Recommended |
DNA Test Yes SCA1 number repeats in normal allele |
|
|
|
|
sca1repeatsexpandallele |
Integer |
|
Recommended |
DNA Test Yes SCA1 number repeats in expanded allele |
|
|
|
|
sca3repeatsnormalallele |
Integer |
|
Recommended |
DNA Test Yes SCA3 number repeats in normal allele |
|
|
|
|
sca3repeatsexpandallele |
Integer |
|
Recommended |
DNA Test Yes SCA3 number repeats in expandedl allele |
|
|
|
|
dxbyfamhist |
Integer |
|
Recommended |
Diagnosed by positive family history only |
0;1
|
1=Yes; 0=No
|
|
|
dxbyfamhistspecify |
Integer |
|
Recommended |
Diagnosed by positive family history DNA or Family history of SCA |
0::2
|
0=SCA1; 1=SCA3; 2=Negative (i.e., control)
|
|
|
dxbyfamhistparentgender |
Integer |
|
Recommended |
Gender of transmitting parent |
0;1;-9
|
0=Female; 1=Male; -9=Unknown
|
|
|
consentcsf |
Integer |
|
Recommended |
Consent for optional spinal tap andor MR substudy Consent to CSF |
0;1
|
1=Yes; 0=No
|
|
|
lumbarpuncturecompleted |
Integer |
|
Recommended |
Was Lumbar Puncture completed during this visit |
0;1
|
1=Yes; 0=No
|
|
|
interestedmrstudy |
Integer |
|
Recommended |
Interested in participating in MR substudy |
0;1
|
1=Yes; 0=No
|
|
|
inc5bcomment |
String |
100
|
Recommended |
Inclusion 5b Comment |
|
|
|
|
controlinc1nosymptoms |
Integer |
|
Recommended |
Inclusion 1 for Control Subjects No symptoms of neurologic deficits including ataxia |
0;1;-9
|
1=Yes; 0=No; -9=NA
|
|
|
controlinc2normalgait |
Integer |
|
Recommended |
Inclusion 2 for Control Subjects Normal gait |
0;1;-9
|
1=Yes; 0=No; -9=NA
|
|
|
controlinc2sarale25 |
Integer |
|
Recommended |
Inclusion 3 for Control Subjects SARA score le 25 |
0;1;-9
|
1=Yes; 0=No; -9=NA
|
|
|
exc1genotypeotheria |
Integer |
|
Recommended |
Exclusion 1 Genotype consistent with other inherited ataxias |
0;1;-9
|
1=Yes; 0=No; -9=Unknown
|
|
|
exc2concomitantdisorder |
Integer |
|
Recommended |
Exclusion 2 Concomitant disorders that affects assessments of ataxia or severity of ataxia |
0;1
|
1=Yes; 0=No
|
|
|
exc3lackofwillingness |
Integer |
|
Recommended |
Exclusion 3 A lack of willingness to participate in the study |
0;1
|
1=Yes; 0=No
|
|
|
sca1repeatsnormalallele2 |
Integer |
|
Recommended |
DNA Test Yes SCA1 number repeats in normal allele 2 |
|
|
|
|
sca3repeatsnormalallele2 |
Integer |
|
Recommended |
DNA Test Yes SCA3 number repeats in normal allele 2 |
|
|
|
|
enroll_clinical_state |
Integer |
|
Recommended |
Clinical state category at time of enrollment |
0::5
|
0 = No FHX of SCA or SCA fam memb with neg DNA; 1 = Early State; 2 = Pre-Ataxia; 3 = 50% at risk; 4 = Previously Early State; 5 = Negative (i.e., control)
|
|
|
current_clinical_state |
Integer |
|
Recommended |
Clinical state category after genotyping |
1::3
|
1 = Ataxia; 2 = Pre-Ataxia; 3 = Negative (i.e., control)
|
|
|
category_after_genotyping |
Integer |
|
Recommended |
The category of the participant after genotyping was completed |
0::2
|
0 = DNA Negative for SCA1 and SCA3; 1 = Ataxia; 2 = Pre-Ataxia
|
|