Long-Term Safety Extension Trial of Asenapine in Bipolar 1 Disorder Participants Who Completed Protocol P05691 (P05692)

Completed · Phase 3

Conditions studied: Bipolar I Disorder

In brief

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.

Key facts

Study ID

NCT01395992

Run by

Forest Laboratories

People needed

165

Starts

2012-04-01

Expected to finish

2015-01-01

Last updated by the study team

2015-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Forest Investigative Site 1000 — Austin, Texas, United States

Full record on ClinicalTrials.gov

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