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

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ClinicalTrials.gov Identifier: NCT01396291
Recruitment Status : Completed
First Posted : July 18, 2011
Last Update Posted : December 4, 2015
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Brief 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.

Condition or disease Intervention/treatment Phase
Bipolar 1 Disorder Drug: asenapine Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 561 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : December 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396291


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Sponsors and Collaborators
Forest Laboratories

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01396291     History of Changes
Other Study ID Numbers: P06384
2010-018671-20 ( EudraCT Number )
First Posted: July 18, 2011    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Disease
Recurrence
Pathologic Processes
Disease Attributes
Asenapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs