Informed Consent Comprehension
Item
subjects must have the ability to comprehend the key components of the consent form.
boolean
C0021430 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
Single major depressive episode
Item
subject must have met dsm-iv-tr (diagnostic and statistical manual of mental disorders, fourth edition, text revision) criteria for current mde (major depressive episode) for at least 8 weeks prior to the screening visit.
boolean
C0024517 (UMLS CUI [1])
Gender Contraceptive methods
Item
if female, subjects must be practicing an acceptable method of birth control.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Global assessment of functioning
Item
subjects must have rating scores as outlined.
boolean
C0561904 (UMLS CUI [1])
Single major depressive episode Symptoms | Diagnosis Suboptimal
Item
subjects whose symptoms of the mde are better accounted for by another diagnosis.
boolean
C0024517 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2,1])
C2984009 (UMLS CUI [2,2])
Schizophrenia | Schizoaffective Disorder | Bipolar Disorder
Item
subjects with a history of schizophrenia, schizoaffective disorders or bipolar disorder.
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
Illicit drug use Urine test Positive | Substance Use Disorders | Alcohol dependence
Item
subjects have a positive urine test for illicit drug use and/or a history of substance abuse or alcohol dependence within the past 12 months.
boolean
C0281875 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0038586 (UMLS CUI [2])
C0001973 (UMLS CUI [3])
Disease Unstable
Item
subjects with an unstable medical disorder.
boolean
C0012634 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
if female, pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Electroconvulsive Therapy | Transcranial magnetic stimulation | homicidal
Item
subjects who have received ect (electroconvulsive therapy) or tms (transcranial magnetic stimulation) within the 6 months preceding screening or who have ever been homicidal.
boolean
C0013806 (UMLS CUI [1])
C0436548 (UMLS CUI [2])
C0745031 (UMLS CUI [3])