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

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT01617200

Run by

Forest Laboratories

People needed

105

Starts

2012-12-01

Expected to finish

2015-03-01

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…

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

You may not qualify if…

• 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

Where it is running

• Forest Investigative Site 2001 — Austin, Texas, United States

Full record on ClinicalTrials.gov

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