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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Bipolar 1 Disorder

Intervention / Treatment
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* Drug: asenapine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception. Each participant must be willing and able to provide written informed consent. Each participant must have an identified external contact person or an identified responsible person. Current diagnosis of Bipolar 1 Disorder, and a current manic (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision [DSM-IV-TR^TM] code 296.4x) or mixed (DSM-IV code 296.6x) episode as determined by a structured clinical interview (Mini International Neuropsychiatric Interview [MINI]) at Screening. Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode. Exclusion criteria: Uncontrolled, unstable clinically significant medical condition. Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram findings at Screening. Current primary Axis I disorder other than bipolar 1 disorder. Meets the current DSM-IV-TR^TM criteria for substance abuse or dependence (excluding nicotine). 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<br>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. | Drug: asenapine<br>* asenapine, sublingual tablets, 5 to 10 mg twice per day (BID)<br>* Other names: SCH 900274, Saphris®, Sycrest®, Org 5222;|
| Placebo Comparator: Placebo<br>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. | Drug: placebo<br>* asenapine-matched placebo, sublingual tablets, BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |