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Completed

NCT Number: NCT01396291

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

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.

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Key information

Conditions

Bipolar 1 Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Forest Investigative Site 3105, Pleven, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

asenapine

Drug

asenapine, sublingual tablets, 5 to 10 mg twice per day (BID)

Other names: SCH 900274, Saphris®, Sycrest®, Org 5222

Placebo

Drug

asenapine-matched placebo, sublingual tablets, BID

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

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)

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 18, 2011
Registry last updated
Dec 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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