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

Phase 3

Completed

• Conditions: Bipolar 1 Disorder
• Interventions: Drug: placebo; Drug: asenapine

• Registration Number: NCT01396291
• Lead Sponsor: Forest Laboratories

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-15
• Study First Posted: 2011-07-18
• Study Start: 2011-12
• Primary Completion: 2015-04
• Study Completion: 2015-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 561

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	All study participants will first receive open-label asenapine and placebo for 12 to 16 weeks before being randomized. After randomization, participants will receive asenapine or placebo (this is the double-blind period) for up to 26 weeks.
Asenapine	asenapine	All study participants will first receive open-label asenapine and placebo for 12 to 16 weeks before being randomized. After randomization, participants will receive asenapine or placebo (this is the double-blind period) for up to 26 weeks.

Primary Outcome Measures

Name	Time	Method
The time (in days) to recurrence of any mood event during the double-blind treatment period	From Week 12 or 16 to Week 38 or 42

Trial Locations

Locations (79)

Forest Investigative Site 3017; 🇺🇸 Anaheim, California, United States

Forest Investigative Site 3019; 🇺🇸 Chino, California, United States

Forest Investigative Site 3001; 🇺🇸 Escondido, California, United States

Forest Investigative Site 3004; 🇺🇸 National City, California, United States

Forest Investigative Site 3006; 🇺🇸 Oakland, California, United States

Forest Investigative Site 3003; 🇺🇸 Orange, California, United States

Forest Investigative Site 3007; 🇺🇸 Torrance, California, United States

Forest Investigative Site 3042; 🇺🇸 Colorado Springs, Colorado, United States

Forest Investigative Site 3012; 🇺🇸 Jacksonville, Florida, United States

Forest Investigative Site 3040; 🇺🇸 Kissimmee, Florida, United States

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