Conditions: Bipolar 1 Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 367
Healthy volunteers: no

Brief summary:
This trial will study the efficacy and safety of a fixed dose of asenapine in participants diagnosed with Bipolar 1 Disorder. Participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine (either 5 mg or 10 mg twice daily \[BID\]) or placebo (BID) for 3 weeks. Throughout the trial, observations will be made on each participant at various times to assess the safety and effectiveness of the study treatment. The primary hypothesis is that there is at least one dose of asenapine that is superior to placebo in the change from baseline in manic symptoms (as measured by Young Mania Rating Scale \[YMRS\]) at Day 21 of the trial.

Detailed description:

Arms:
arm 1: Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days arm 2: Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days arm 3: Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days

Interventions: intervention 1: Asenapine intervention 2: Asenapine intervention 3: Placebo
Intervention descriptions: intervention 1: asenapine tablet, 5 mg sublingually BID for 21 days intervention 2: asenapine tablet, 10 mg sublingually BID for 21 days intervention 3: placebo sublingual tablet, administered BID for 21 days

Protocol document: