- Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria for Bipolar I
disorder (manic or mixed)
- At the screening and baseline visits, subjects must have a Young Mania Rating Scale
(YMRS) score of at least 17.
- The subject must have a Body Mass Index (BMI) z score between -1.65 and +2.00,
- Imminent risk of suicide or homicide, as judged by the site investigator
- Any history of serious or unstable illness
- Risk for prolonged QT