Long-Term Safety Extension Trial of Asenapine in Schizophrenia Participants Who Completed Protocol P05688 (P05689)

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Participants who have completed the 6-week trial P05688 can be screened for eligibility for this 26-week extension study in which they will continue treatment. The purpose of this trial is to evaluate the long-term safety of 2.5 and 5 mg asenapine administered sublingually twice daily (BID) in schizophrenia participants. Olanzapine administered 15 mg orally once daily (QD) is used as an active control.

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

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Asenapine; Olanzapine

Criteria

Inclusion Criteria:

• Completed the short-term trial P05688, and judged by the investigator likely to benefit from continued treatment

Exclusion Criteria:

• Occurrence(s) of an adverse event or other clinically significant finding(s) in the short-term trial P05688 that would prohibit the participant's continuation into the long-term extension

• Clinical Global Impression-Severity of Illness (CGI-S) score of ≥6 (severely psychotic) at Baseline

• Newly diagnosed or discovered psychiatric condition that would have excluded the participant from participation in the short-term trial P05688