Adult | Principal diagnosis Moderate Major depressive disorder Without Psychotic symptom | Principal diagnosis Severe major depression without psychotic features | Disease length | Single major depressive episode Previous
Item
adult subjects with primary diagnosis of moderate to severe mdd without psychotic features, for at least 4 weeks and one previous mdd episode
boolean
C0001675 (UMLS CUI [1])
C0332137 (UMLS CUI [2,1])
C1741422 (UMLS CUI [2,2])
C0332288 (UMLS CUI [2,3])
C0871189 (UMLS CUI [2,4])
C0332137 (UMLS CUI [3,1])
C0270457 (UMLS CUI [3,2])
C0872146 (UMLS CUI [4])
C0024517 (UMLS CUI [5,1])
C0205156 (UMLS CUI [5,2])
Gender | Childbearing Potential Contraceptive methods Agreement
Item
males or females who agree to use protocol specified contraception if of child bearing potential
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0680240 (UMLS CUI [2,3])
Body mass index
Item
bmi 18.5-35.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Liver Function Tests
Item
normal liver function tests
boolean
C0023901 (UMLS CUI [1])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Liver diseases | Hepatitis B surface antigen positive | Hepatitis C antibody positive
Item
history of liver disease or positive hepatitis b surface antigen or hepatitis c antibody in the last 3 months
boolean
C0023895 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0281863 (UMLS CUI [3])
Increased liver function tests Occurrence Quantity
Item
elevated liver function tests on >2 ocassions in the last 7 months
boolean
C0877359 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Illness Significant | Autoimmune Disease | Communicable Disease
Item
significant medical illness, autoimmune disease or infectious disease
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0004364 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or nursing females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Alcohol intake above recommended sensible limits Regular
Item
excessive and regular alcohol consumption
boolean
C0560219 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Substance Use Disorders | Substance Dependence | Urine drug screen positive
Item
history of substance abuse or dependence in past 6 months or positive urine drug screen
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
C0743300 (UMLS CUI [3])
At risk for suicide | At risk Homicide
Item
significant suicidal or homicidal risk
boolean
C0563664 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0019872 (UMLS CUI [2,2])
Antiinflammatory therapy biological chronic | Antiinflammatory therapy pharmacological chronic | Euthyroid Absent
Item
currently receiving chronic biological or pharmacologic anti-inflammatory therapy or is not euthyroid
boolean
C1096024 (UMLS CUI [1,1])
C0205460 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C1096024 (UMLS CUI [2,1])
C0205464 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C0117002 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Psychotropic Drugs
Item
psychoactive drugs within 1 week or 5 half lives of randomization visit
boolean
C0033978 (UMLS CUI [1])
Study Subject Treatment Resistant Disorders
Item
treatment resistant subjects
boolean
C0681850 (UMLS CUI [1,1])
C0871547 (UMLS CUI [1,2])