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

This study has been completed.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
First received: July 14, 2011
Last updated: July 17, 2015
Last verified: July 2015
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.

Condition Intervention Phase
Bipolar 1 Disorder
Drug: asenapine
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:

Further study details as provided by Forest Laboratories:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 561
Study Start Date: December 2011
Study Completion Date: June 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: asenapine
asenapine, sublingual tablets, 5 to 10 mg twice per day (BID)
Other Name: SCH 900274, Saphris®, Sycrest®, Org 5222
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.
Drug: placebo
asenapine-matched placebo, sublingual tablets, BID


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396291

United States, California
Forest Investigative Site 3017
Anaheim, California, United States, 92805
Forest Investigative Site 3019
Chino, California, United States, 91710
Forest Investigative Site 3001
Escondido, California, United States, 92025
Forest Investigative Site 3004
National City, California, United States, 91950
Forest Investigative Site 3006
Oakland, California, United States, 94612
Forest Investigative Site 3003
Orange, California, United States, 92868
Forest Investigative Site 3007
Torrance, California, United States, 90502
United States, Florida
Forest Investigative Site 3012
Jacksonville, Florida, United States, 32256
Forest Investigative Site 3015
Miami, Florida, United States, 33126
Forest Investigative Site 3010
Tampa, Florida, United States, 33613
United States, Kansas
Forest Investigative Site 3021
Witchita, Kansas, United States, 67207
United States, Missouri
Forest Investigative Site 3014
Gladstone, Missouri, United States, 64118
United States, New Mexico
Forest Investigative Site 3002
Albuquerque, New Mexico, United States, 87108
United States, New York
Forest Investigative Site 3024
Elmsford, New York, United States, 10523
United States, Oklahoma
Forest Investigative Site 3023
Oklahoma City, Oklahoma, United States, 73112
United States, Texas
Forest Investigative Site 3009
Houston, Texas, United States, 77030
Forest Investigative Site 3020
Houston, Texas, United States, 77090
Forest Investigative Site 3000
Wichita Falls, Texas, United States, 76309
Sponsors and Collaborators
Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01396291     History of Changes
Other Study ID Numbers: P06384, 2010-018671-20
Study First Received: July 14, 2011
Last Updated: July 17, 2015
Health Authority: United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency

Additional relevant MeSH terms:
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 24, 2015