NCT01396291

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

A Double-Blind, Placebo-Controlled Trial of Asenapine in the Prevention of Recurrence of a Mood Episode After Stabilization of an Acute Manic/Mixed Episode in Subjects With Bipolar 1 Disorder (Phase 3B, Protocol P06384)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 561 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to evaluate the efficacy and safety of asenapine as compared to placebo in preventing the recurrence of mood episodes after stabilization of an acute/manic mixed episode in participants with Bipolar 1 Disorder. After a Screening Period, each participant will receive open-label asenapine and matching placebo for 12 to 16 weeks. Participants who meet stabilization criteria may then be randomized into one of the two study arms (asenapine or matching placebo) to receive double-blind treatment for up to an additional 26-weeks.

Conditions

• Bipolar 1 Disorder

Interventions

Type	Name	Description
DRUG	asenapine	asenapine, sublingual tablets, 5 to 10 mg twice per day (BID)
DRUG	placebo	asenapine-matched placebo, sublingual tablets, BID

Timeline

• Start date: 2011-12-01
• Primary completion: 2015-04-01
• Completion: 2015-06-01
• First posted: 2011-07-18
• Last updated: 2015-12-04

Locations

80 sites across 10 countries: United States, Bulgaria, Croatia, India, Philippines, Romania, Russia, Serbia, Turkey (Türkiye), Ukraine