- Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode
depressed, with or without rapid cycling, without psychotic features, as defined in
Diagnostic and Statistical Manual (of Mental Disorders) - Fourth Edition - Text
Revision (DSM-IV-TR) (296.5X) and confirmed by a structured Mini International
Neuropsychiatric Interview (MINI)
- Subjects with a DSM-IV TR diagnosis of schizophrenia (295.XX), schizoaffective
disorder (295.70), schizophreniform disorder (295.40), delusional disorder (297.1), or
psychotic disorder not otherwise specified (298.9).
- Subjects with other DSM-IV TR Axis I or Axis II disorder (in addition to Bipolar I
disorder) are ineligible if the comorbid condition is clinically unstable, requires
treatment, or has been a primary focus of treatment within the 6 month period prior to
screening.