drugset / Trial / NCT00145470

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)

NCT00145470

Phase 3 Completed 326 enrolled Organon and Co
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2005-06-02
Primary completion
2007-02-28
Completion
2007-03-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Asenapine Other / unclassified 5 mg Other
Subject Asenapine Other / unclassified 10 mg Other

Indications