Long-Term Safety Extension Trial of Asenapine in Bipolar 1 Disorder Participants Who Completed Protocol P05691 (P05692)

Phase 3

Completed

• Conditions: Bipolar I Disorder
• Interventions: Drug: asenapine

• Registration Number: NCT01395992
• Lead Sponsor: Forest Laboratories

Brief Summary

Participants who have completed the 3-week trial P05691 (NCT00764478) can be screened for eligibility for this 26-week extension study in which they will continue treatment. The primary purpose of this trial is to evaluate the long-term safety of asenapine.

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: 2012-04
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Asenapine 5 mg	asenapine	Participants who were randomized to asenapine 5 mg twice per day (BID) during the P05691 study will be assigned to receive asenapine 5 mg BID on this extension study. Participant who were randomized to placebo during the P05691 study will be assigned to receive asenapine 5 mg BID on this extension trial.
Asenapine 10 mg	asenapine	Participants who were randomized to asenapine 10 mg BID during the P05691 study will be assigned to receive asenapine 10 mg BID on this extension study.

Primary Outcome Measures

Name	Time	Method
Number of participants experiencing clinical and laboratory adverse events (AEs)	Baseline up to 212 days

Trial Locations

Locations (1)

Forest Investigative Site 1000; 🇺🇸 Austin, Texas, United States