- Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode
manic (296.4x), or mixed (296.6x) as defined in Diagnostic and Statistical Manual of
Mental Disorders - Text Revision (DSM-IV TR) and determined by the Mini International
Neuropsychiatric Interview (MINI).
- At screening and at baseline (within 12 hours prior to the first dose of double-blind
medication) subjects must have a Young Mania Rating Scale score of 18 or higher.
- Subjects must be actively receiving lithium or divalproex for their bipolar disorder
in order to be considered for this study.
- Subjects with a Diagnostic and Statistical Manual of Mental Disorders IV- Text
Revision (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 (NOS) (298.9).
- Subjects with other DSM-IV-TR Axis I or Axis II disorders (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.