Long-Term Safety Extension Trial of Asenapine in Bipolar 1 Disorder Participants Who Completed Protocol P05691 (P05692)
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])
2 other identifiers
interventional
165
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2012
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2011
CompletedFirst Posted
Study publicly available on registry
July 18, 2011
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedMay 27, 2015
May 1, 2015
2.7 years
July 14, 2011
May 26, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants experiencing clinical and laboratory adverse events (AEs)
Baseline up to 212 days
Study Arms (2)
Asenapine 5 mg
EXPERIMENTALParticipants 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.
Asenapine 10 mg
EXPERIMENTALParticipants 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.
Interventions
asenapine 5 mg tablet, sublingually (SL) twice daily (BID) for 182 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Forest Investigative Site 1000
Austin, Texas, 78754, United States
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2011
First Posted
July 18, 2011
Study Start
April 1, 2012
Primary Completion
December 1, 2014
Study Completion
January 1, 2015
Last Updated
May 27, 2015
Record last verified: 2015-05