Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384)

Inclusion Criteria

• •Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception.
• •Each participant must be willing and able to provide written informed consent.
• •Each participant must have an identified external contact person or an identified responsible person.
• •Current diagnosis of Bipolar 1 Disorder, and a current manic (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision \[DSM-IV-TR\^TM\] code 296.4x) or mixed (DSM-IV code 296.6x) episode as determined by a structured clinical interview (Mini International Neuropsychiatric Interview \[MINI\]) at Screening.
• •Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode.