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Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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)

NCT01396291•Forest Laboratories

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (80)

Forest Investigative Site 3017

Anaheim, California, United States

Forest Investigative Site 3019

Chino, California, United States

Forest Investigative Site 3001

Escondido, California, United States

Forest Investigative Site 3004

National City, California, United States

Forest Investigative Site 3006

Oakland, California, United States

Forest Investigative Site 3003

Orange, California, United States

Forest Investigative Site 3007

Torrance, California, United States

Forest Investigative Site 3042

Colorado Springs, Colorado, United States

Forest Investigative Site 3012

Jacksonville, Florida, United States

Forest Investigative Site 3040

Kissimmee, Florida, United States

Key Dates

Start Date

December 1, 2011

Primary Completion Date

April 1, 2015

Completion Date

June 1, 2015

Last Updated

December 4, 2015

Enrollment

561

ACTUAL participants

Conditions

Bipolar 1 Disorder

Interventions

asenapine

DRUG

placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

CLOZAPINE Response in Biotype-1

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