NCT00764478

Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691)

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])

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 367 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar 1 Disorder

Interventions

Type	Name	Description
DRUG	Asenapine	asenapine tablet, 5 mg sublingually BID for 21 days
DRUG	Asenapine	asenapine tablet, 10 mg sublingually BID for 21 days
DRUG	Placebo	placebo sublingual tablet, administered BID for 21 days

Timeline

• Start date: 2012-04-06
• Primary completion: 2014-04-30
• Completion: 2014-05-28
• First posted: 2008-10-02
• Last updated: 2024-06-18
• Results posted: 2015-04-24