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)

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

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Asenapine; p = 0.0257; ANCOVA; note: P-value based on the difference in the least squares (LS) means for asenapine versus placebo. NCT00145470 ↗

paper Adjunctive asenapine significantly improved mania versus placebo at week 3 (primary end point) PMID 22198448 ↗

Publications

• Results Szegedi A, Calabrese JR, Stet L, Mackle M, Zhao J, Panagides J; Apollo Study Group. Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension. J Clin Psychopharmacol. 2012 Feb;32(1):46-55. doi: 10.1097/JCP.0b013e31823f872f.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Asenapine	Other / unclassified	5 mg	Other
Subject	Asenapine	Other / unclassified	10 mg	Other

Indications