Long-Term Safety Extension Trial of Asenapine in Bipolar 1 Disorder Participants Who Completed Protocol P05691 (P05692)
Status: | Completed |
---|---|
Conditions: | Psychiatric, Bipolar Disorder |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/5/2014 |
Start Date: | April 2012 |
End Date: | December 2014 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
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])
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.
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.
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
We found this trial at
31
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