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

Sponsor
Forest Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT01395992
Collaborator
(none)
165
Enrollment
1
Location
2
Arms
33
Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
165 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (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])
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Jan 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Saphris®, SCH 900274, Org 5222, Sycrest®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants experiencing clinical and laboratory adverse events (AEs) [Baseline up to 212 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Forest Investigative Site 1000 Austin Texas United States 78754

    Sponsors and Collaborators

    • Forest Laboratories

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Forest Laboratories
    ClinicalTrials.gov Identifier:
    NCT01395992
    Other Study ID Numbers:
    • P05692
    • 2010-018410-78
    First Posted:
    Jul 18, 2011
    Last Update Posted:
    May 27, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Disease
    Asenapine

    Study Results

    No Results Posted as of May 27, 2015