Conditions: Bipolar Disorder
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 218
Healthy volunteers: no

Brief summary:
Bipolar disorder is characterized by mood swings that range from from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. Patients who completed study A7501006 (a 9 week extension study) could continue with the same treatment that they had been receiving: asenapine or olanzapine (a medication that is already approved for the treatment of bipolar mania) in a 40 -week continuation study.

Detailed description:

Arms:
arm 1: Asenapine 5-10 mg twice daily for 40 weeks arm 2: Olanzapine 5-20 mg once daily for 40 weeks

Interventions: intervention 1: asenapine intervention 2: Olanzapine
Intervention descriptions: intervention 1: Asenapine, 40 weeks intervention 2: Olanzapine, 40 weeks

Protocol document: