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: December 3, 2015
Last verified: December 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

  Show 80 Study Locations
Sponsors and Collaborators
Forest Laboratories
  More Information

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: December 3, 2015
Health Authority: United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency
Croatia: Agency for Medicinal Product and Medical Devices
India: Indian Council of Medical Research
Philippines: Philippine Council for Health Research and Development
Romania: National Agency for Medicines and Medical Devices
Russia: Pharmacological Committee, Ministry of Health
Serbia: Medicines and Medical Devices Agency
Turkey: Ministry of Health
Ukraine: Ministry of Health

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 April 27, 2016