- 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
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 NOS (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.