12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008 / P05844 / MK-8274-017)

• Status: Completed
• Trial end date: 2007-03-22
• Target enrollment: 0
• Participant gender: All

Summary

This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder.

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Asenapine

Criteria

Inclusion Criteria:

• Have bipolar I disorder, current episode manic or mixed

• Treated with lithium or valproic acid

Exclusion Criteria:

• Have an unstable medical condition

• Clinically significant laboratory abnormality.

• Have a primary diagnosis other than bipolar I disorder.