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Long-Term Safety Extension Trial of Asenapine in Bipolar 1 Disorder Participants Who Completed Protocol P05691 (P05692)

This study has been completed.
Information provided by (Responsible Party):
Forest Laboratories Identifier:
First received: July 14, 2011
Last updated: May 26, 2015
Last verified: May 2015
Participants who have completed the 3-week trial P05691 (NCT00764478) can be screened for eligibility for this 26-week extension study in which they will continue treatment. The primary purpose of this trial is to evaluate the long-term safety of asenapine.

Condition Intervention Phase
Bipolar I Disorder
Drug: asenapine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of Asenapine in Subjects Diagnosed With Bipolar 1 Disorder Who Completed Protocol P05691 (Formerly 041044) (Phase3B, Protocol P05692 [Formerly 041045])

Resource links provided by NLM:

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Number of participants experiencing clinical and laboratory adverse events (AEs) [ Time Frame: Baseline up to 212 days ]

Enrollment: 165
Study Start Date: April 2012
Study Completion Date: January 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asenapine 5 mg
Participants who were randomized to asenapine 5 mg twice per day (BID) during the P05691 study will be assigned to receive asenapine 5 mg BID on this extension study. Participant who were randomized to placebo during the P05691 study will be assigned to receive asenapine 5 mg BID on this extension trial.
Drug: asenapine
asenapine 5 mg tablet, sublingually (SL) twice daily (BID) for 182 days
Other Name: Saphris®, SCH 900274, Org 5222, Sycrest®
Experimental: Asenapine 10 mg
Participants who were randomized to asenapine 10 mg BID during the P05691 study will be assigned to receive asenapine 10 mg BID on this extension study.
Drug: asenapine
asenapine 10 mg tablet, SL BID for 182 days
Other Name: Saphris®, SCH 900274, Org 5222, Sycrest®


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

Inclusion criteria:

  • Each participant must have completed the short-term trial P05691, and be judged by the investigator to likely benefit from continued treatment
  • Each participant must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the short-term trial P05691

Exclusion criteria:

  • A participant must not have had any adverse event or other clinically significant finding(s) in the short-term trial P05691 that would prohibit the subject's continuation into this long-term extension trial
  • A participant must not have any newly diagnosed or discovered psychiatric condition that would have excluded the subject from participation in the short-term trial P05691
  • A participant must not be at imminent risk of self-harm or harm to others
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Please refer to this study by its identifier: NCT01395992

United States, Texas
Forest Investigative Site 1000
Austin, Texas, United States, 78754
Sponsors and Collaborators
Forest Laboratories
  More Information

Responsible Party: Forest Laboratories Identifier: NCT01395992     History of Changes
Other Study ID Numbers: P05692
2010-018410-78 ( EudraCT Number )
Study First Received: July 14, 2011
Last Updated: May 26, 2015

Additional relevant MeSH terms:
Pathologic Processes
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on May 22, 2017