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

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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.


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
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