At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3b, Multicenter, Double-Blind, Fixed-Dose, Parallel-Group, Three Week Placebo Controlled Trial Evaluating the Safety and Efficacy of Asenapine in Subjects With Bipolar 1 Disorder Experiencing an Acute Manic or Mixed Episode (Protocol P05691 [Formerly 041044])
In Brief
A Phase 3 clinical trial evaluating Asenapine and Placebo for Bipolar 1 Disorder. Completed, enrolled 367 participants.
Detailed 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.
Study Details
Timeline
Interventions
asenapine tablet, 5 mg sublingually BID for 21 days
asenapine tablet, 10 mg sublingually BID for 21 days
placebo sublingual tablet, administered BID for 21 days