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Long-Term Safety Extension Trial of Asenapine in Schizophrenia Participants Who Completed Protocol P05688 (P05689)

Sponsor
Forest Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT01617200
Collaborator
(none)
105
Enrollment
1
Location
4
Arms
26.9
Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Participants who have completed the 6-week trial P05688 can be screened for eligibility for this 26-week extension study in which they will continue treatment. The purpose of this trial is to evaluate the long-term safety of 2.5 and 5 mg asenapine administered sublingually twice daily (BID) in schizophrenia participants. Olanzapine administered 15 mg orally once daily (QD) is used as an active control.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of Asenapine Using Olanzapine as an Active Control in Subjects Diagnosed With Schizophrenia Who Completed Protocol P05688
Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Asenapine 2.5 mg BID

Drug: Asenapine
2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually, same number of tablets are taken in the morning and the evening
Other Names:
  • Saphris®
  • SCH 900274
  • Org 5222
  • Sycrest®

    • Drug: Placebo Olanzapine
    15 mg film-coated placebo olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.
    Experimental: Asenapine 5 mg BID

    Drug: Asenapine
    2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually, same number of tablets are taken in the morning and the evening
    Other Names:
  • Saphris®
  • SCH 900274
  • Org 5222
  • Sycrest®

    • Drug: Placebo Olanzapine
    15 mg film-coated placebo olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.
    Active Comparator: Olanzapine 15 mg QD

    Drug: Placebo Asenapine
    2.5 mg or 5 mg fast dissolving placebo asenapine tablets administered sublingually, same number of tablets are taken in the morning and the evening

    Drug: Olanzapine
    15 mg film-coated active olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.
    Other Names:
  • Zyprexa

    • Drug: Placebo Olanzapine
    15 mg film-coated placebo olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.
    Experimental: Placebo switched to Asenapine 2.5 mg BID

    Drug: Asenapine
    2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually, same number of tablets are taken in the morning and the evening
    Other Names:
  • Saphris®
  • SCH 900274
  • Org 5222
  • Sycrest®

    • Drug: Placebo Olanzapine
    15 mg film-coated placebo olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.

    Outcome Measures

    Primary Outcome Measures

    1. Change in Weight From Baseline to Day 182 [Baseline (Day -1 of Short Term Trial) to Day 182 (Long-Term Extension)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Completed the short-term trial P05688, and judged by the investigator likely to benefit from continued treatment
    Exclusion Criteria:

    • Occurrence(s) of an adverse event or other clinically significant finding(s) in the short-term trial P05688 that would prohibit the participant's continuation into the long-term extension

    • Clinical Global Impression-Severity of Illness (CGI-S) score of ≥6 (severely psychotic) at Baseline

    • Newly diagnosed or discovered psychiatric condition that would have excluded the participant from participation in the short-term trial P05688

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Forest Investigative Site 2001 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:
    NCT01617200
    Other Study ID Numbers:
    • P05689
    • 2010-018408-96
    First Posted:
    Jun 12, 2012
    Last Update Posted:
    May 27, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Schizophrenia
    Olanzapine
    Asenapine

    Study Results

    No Results Posted as of May 27, 2015