Depression, Bipolar
Item
1. dsm-iv-tr diagnosis of bipolar i depression
boolean
C0005587 (UMLS CUI [1])
Age
Item
2. 18 to 65 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
Depressive episode Montgomery-Asberg Depression Rating Scale Questionnaire
Item
3. depressive phase, as measured by madrs greater than or equal to 20 at screening and day1
boolean
C0349217 (UMLS CUI [1,1])
C4054475 (UMLS CUI [1,2])
Depressive episode Duration
Item
4. duration of current depressive episode of at least four weeks by day 1
boolean
C0349217 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Informed Consent
Item
5. competent to give informed consent
boolean
C0021430 (UMLS CUI [1])
Manic episode Mini-mental state examination | hypomanic episode Mini-mental state examination | Episode Mixed Mini-mental state examination | Young Mania Rating Scale Questionnaire
Item
1. manic/hypomanic/mixed episode as determined by the mini at screening and/or a young mania rating scale (ymrs) score of > 12 at screening and/or day 1
boolean
C0349208 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
C1396834 (UMLS CUI [2,1])
C0451306 (UMLS CUI [2,2])
C0332189 (UMLS CUI [3,1])
C0205430 (UMLS CUI [3,2])
C0451306 (UMLS CUI [3,3])
C3640523 (UMLS CUI [4])
Dementia Requirement Pharmacotherapy | Axis I diagnosis Requirement Pharmacotherapy | Bipolar I disorder
Item
2. dementia or any current axis i diagnosis (excluding bipolar i) requiring pharmacological treatments
boolean
C0497327 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
C0270287 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0013216 (UMLS CUI [2,3])
C0853193 (UMLS CUI [3])
Substance Dependence | Substance Use Disorders
Item
3. a history of alcohol or substance dependence within six months of day 1, or a history of alcohol or substance abuse within three months of day 1
boolean
C0038580 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
Urine drug screen positive Amphetamines | Urine drug screen positive Cocaine metabolite | Urine drug screen positive Opiates | Urine drug screen positive Phencyclidine
Item
4. urine drug screen positive for amphetamines, cocaine metabolites, opiates and/or phencyclindine (pcp)
boolean
C0743300 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
C0743300 (UMLS CUI [2,1])
C1455816 (UMLS CUI [2,2])
C0743300 (UMLS CUI [3,1])
C0376196 (UMLS CUI [3,2])
C0743300 (UMLS CUI [4,1])
C0031381 (UMLS CUI [4,2])
Axis II diagnosis Interferes with Protocol Compliance
Item
5. an axis ii diagnosis that is likely to interfere with protocol compliance
boolean
C0270288 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Psychotherapy Initiation | Psychotherapy Increase
Item
6. initiation of or increase in psychotherapy within 4 weeks of screening
boolean
C0033968 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
C0033968 (UMLS CUI [2,1])
C0442805 (UMLS CUI [2,2])
Psychotropic Drugs | Fluoxetine
Item
7. psychotropic medication (excluding fluoxetine) within 24 hours of initiation of study drug on day 1; fluoxetine within 2 weeks of initiation of study drug on day 1
boolean
C0033978 (UMLS CUI [1])
C0016365 (UMLS CUI [2])
At risk for suicide Serious Montgomery-Asberg Depression Rating Scale Questionnaire | Homicide Risk Serious Montgomery-Asberg Depression Rating Scale Questionnaire
Item
8. serious suicidal or homicidal risk as determined by the investigator and/or a score of > 5 on the suicide item #10 of the madrs at screening and/or day 1
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C4054475 (UMLS CUI [1,3])
C0019872 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
C4054475 (UMLS CUI [2,4])
Hypersensitivity Investigational New Drug Ingredient
Item
9. history of sensitivity to any of the ingredients in the study drug
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
Laboratory test result abnormal Clinical Significance
Item
10. clinically significant abnormality in any screening laboratory results
boolean
C0438215 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Organic disease Clinical Significance | Cardiovascular Diseases | Endocrine System Diseases | Liver diseases | Lung diseases | nervous system disorder | Kidney Diseases | Medical condition Interferes with Study Protocol | Illness Serious Interferes with Study Protocol
Item
11. clinically significant organic disease, including cardiovascular, endocrine, hepatic, pulmonary, neurologic, or renal disease, or any other medical condition, serious intercurrent illness, or extenuating circumstances that, in the opinion of the investigator, would interfere with the performance or interpretability of, or put the patient at risk from, the study procedures
boolean
C0683324 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C0014130 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0024115 (UMLS CUI [5])
C0027765 (UMLS CUI [6])
C0022658 (UMLS CUI [7])
C3843040 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C2348563 (UMLS CUI [8,3])
C0221423 (UMLS CUI [9,1])
C0205404 (UMLS CUI [9,2])
C0521102 (UMLS CUI [9,3])
C2348563 (UMLS CUI [9,4])
Pregnancy | Breast Feeding | Gender Contraceptive methods Refused
Item
12. women who are pregnant, breastfeeding, or refuse to use adequate birth control
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1705116 (UMLS CUI [3,3])
Epilepsy
Item
13. current seizure disorder
boolean
C0014544 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
14. participation in an investigational drug study within twenty-eight days of day 1
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Psychotic episode
Item
15. current psychotic episode
boolean
C0338614 (UMLS CUI [1])
Clozaril | Electroconvulsive Therapy
Item
16. clozaril use and/or electroconvulsive therapy within six months of day 1
boolean
C0719386 (UMLS CUI [1])
C0013806 (UMLS CUI [2])
Depressive disorder Standard of Care Quantity failed
Item
17. failure of three or more adequate trials of standard therapies for depression during the current episode
boolean
C0011581 (UMLS CUI [1,1])
C2936643 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
Depressive episode Duration
Item
18. current episode of depression is longer than one year
boolean
C0349217 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])