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

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2015

Interventions

  • Drug: asenapine
    • asenapine, sublingual tablets, 5 to 10 mg twice per day (BID)
  • Drug: placebo
    • asenapine-matched placebo, sublingual tablets, BID

Arms, Groups and Cohorts

  • Experimental: 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.
  • Placebo Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Forest Laboratories
  • Provider of Information About this Clinical Study
    • Sponsor

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