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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of Asenapine in Subjects Diagnosed With Bipolar 1 Disorder Who Completed Protocol P05691 (Formerly 041044) (Phase3B, Protocol P05692 [Formerly 041045])

Conditions
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Bipolar I Disorder

Intervention / Treatment
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* Drug: asenapine
* Drug: asenapine


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Each participant must have completed the short-term trial P05691, and be judged by the investigator to likely benefit from continued treatment Each participant must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the short-term trial P05691 Exclusion criteria: A participant must not have had any adverse event or other clinically significant finding(s) in the short-term trial P05691 that would prohibit the subject's continuation into this long-term extension trial A participant must not have any newly diagnosed or discovered psychiatric condition that would have excluded the subject from participation in the short-term trial P05691 A participant must not be at imminent risk of self-harm or harm to others

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asenapine 5 mg<br>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. | Drug: asenapine<br>* asenapine 5 mg tablet, sublingually (SL) twice daily (BID) for 182 days<br>* Other names: Saphris®, SCH 900274, Org 5222, Sycrest®;|
| Experimental: Asenapine 10 mg<br>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. | Drug: asenapine<br>* asenapine 10 mg tablet, SL BID for 182 days<br>* Other names: Saphris®, SCH 900274, Org 5222, Sycrest®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants experiencing clinical and laboratory adverse events (AEs) |  | Baseline up to 212 days |