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

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Asenapine

Criteria

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