Informed Consent | Age
Item
1. provide written informed consent and is 18 to 75 years of age inclusive.
boolean
C0021430 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Bipolar I disorder | Depressive episode Without Psychotic feature
Item
2. meets dsm-iv-tr criteria for bipolar i disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features.
boolean
C0853193 (UMLS CUI [1])
C0349217 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0743076 (UMLS CUI [2,3])
Manic episode Bipolar Quantity Lifetime | Mixed manic depressive episode Quantity Lifetime
Item
3. has a lifetime history of at least one bipolar manic or mixed manic episode.
boolean
C0349208 (UMLS CUI [1,1])
C0443156 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C4071830 (UMLS CUI [1,4])
C1608433 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C4071830 (UMLS CUI [2,3])
Lithium | Valproic Acid | Lithium Treatment Willing | Valproic Acid Treatment Willing
Item
4. currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex.
boolean
C0023870 (UMLS CUI [1])
C0042291 (UMLS CUI [2])
C0023870 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0600109 (UMLS CUI [3,3])
C0042291 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0600109 (UMLS CUI [4,3])
Pregnancy Absent | Breast Feeding Absent | Planned Pregnancy Absent
Item
5. not pregnant or nursing and is not planning pregnancy within the projected duration of the study.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0032992 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods
Item
6. females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after
boolean
C3831118 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Physical Health Good Medical History | Physical Health Good Physical Examination | Physical Health Good Laboratory Screening
Item
7. good physical health on the basis of medical history, physical examination, and laboratory screening.
boolean
C0517226 (UMLS CUI [1,1])
C0205170 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0517226 (UMLS CUI [2,1])
C0205170 (UMLS CUI [2,2])
C0031809 (UMLS CUI [2,3])
C0517226 (UMLS CUI [3,1])
C0205170 (UMLS CUI [3,2])
C4542589 (UMLS CUI [3,3])
At risk for suicide | At risk Self-harm | Risk of harm to others | At risk Damage Property
Item
1. subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
boolean
C0563664 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0424366 (UMLS CUI [2,2])
C0549013 (UMLS CUI [3])
C1444641 (UMLS CUI [4,1])
C1883709 (UMLS CUI [4,2])
C2347695 (UMLS CUI [4,3])
CNS disorder chronic | Exception Bipolar I disorder
Item
2. any chronic organic disease of the cns (other than bipolar i disorder).
boolean
C0007682 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0853193 (UMLS CUI [2,2])
Hospitalization Manic episode | Hospitalization Mixed manic depressive episode
Item
3. hospitalization for a manic or mixed episode within the past two months.
boolean
C0019993 (UMLS CUI [1,1])
C0349208 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C1608433 (UMLS CUI [2,2])
Compound Investigational
Item
4. used investigational compound within past 6 months.
boolean
C1706082 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
Substance Use Disorders | Substance Dependence
Item
5. clinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])