Back to resultsLong-Term Safety Extension Trial of Asenapine in Schizophrenia Participants Who Completed Protocol P05688 (P05689)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Asenapine
Placebo Asenapine
Olanzapine
Placebo Olanzapine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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
Sites / Locations
- Forest Investigative Site 2001
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Experimental
Arm Label
Asenapine 2.5 mg BID
Asenapine 5 mg BID
Olanzapine 15 mg QD
Placebo switched to Asenapine 2.5 mg BID
Arm Description
Outcomes
Primary Outcome Measures
Change in Weight From Baseline to Day 182
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01617200
Brief Title
Long-Term Safety Extension Trial of Asenapine in Schizophrenia Participants Who Completed Protocol P05688 (P05689)
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 Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Asenapine 2.5 mg BID
Arm Type
Experimental
Arm Title
Asenapine 5 mg BID
Arm Type
Experimental
Arm Title
Olanzapine 15 mg QD
Arm Type
Active Comparator
Arm Title
Placebo switched to Asenapine 2.5 mg BID
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Asenapine
Other Intervention Name(s)
Saphris®, SCH 900274, Org 5222, Sycrest®
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo Asenapine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Zyprexa
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo Olanzapine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Weight From Baseline to Day 182
Time Frame
Baseline (Day -1 of Short Term Trial) to Day 182 (Long-Term Extension)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Forest Investigative Site 2001
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Long-Term Safety Extension Trial of Asenapine in Schizophrenia Participants Who Completed Protocol P05688 (P05689)
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