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

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar 1 Disorder

In brief

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.

Key facts

Study ID

NCT01396291

Run by

Forest Laboratories

People needed

561

Starts

2011-12-01

Expected to finish

2015-06-01

Last updated by the study team

2015-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Forest Investigative Site 3031 — Leesburg, Florida, United States
• Forest Investigative Site 3015 — Miami, Florida, United States
• Forest Investigative Site 3010 — Tampa, Florida, United States
• Forest Investigative Site 3039 — Atlanta, Georgia, United States
• Forest Investigative Site 3032 — Chicago, Illinois, United States
• Forest Investigative Site 3029 — Schaumburg, Illinois, United States
• Forest Investigative Site 3021 — Witchita, Kansas, United States
• Forest Investigative Site 3014 — Gladstone, Missouri, United States
• Forest Investigative Site 3002 — Albuquerque, New Mexico, United States
• Forest Investigative Site 3024 — Elmsford, New York, United States
• Forest Investigative Site 3037 — Avon Lake, Ohio, United States
• Forest Investigative Site 3041 — Cincinnati, Ohio, United States
• Forest Investigative Site 3023 — Oklahoma City, Oklahoma, United States
• Forest Investigative Site 3035 — Oklahoma City, Oklahoma, United States
• Forest Investigative Site 3033 — Memphis, Tennessee, United States
• Forest Investigative Site 3017 — Anaheim, California, United States

Full record on ClinicalTrials.gov

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