Who is sponsoring NCT00257972?

NCT00257972 is sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc..

What condition does NCT00257972 study?

NCT00257972 studies Bipolar Disorder.

What is the status of NCT00257972?

NCT00257972 is currently COMPLETED.

Last reviewed 2013-11-07 · How we verify

Efficacy of Aripiprazole in Combination With Valproate or Lithium in the Treatment of Mania in Patients With Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy

NCT00257972 Phase 3 COMPLETED

The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.

Details

Lead sponsor	Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	400
Start date	2004-10
Completion	2007-12

Conditions

Bipolar Disorder

Interventions

aripiprazole

Primary outcomes

Change from baseline to endpoint in a mania rating scale

Countries

United States, Australia, Bulgaria, Czechia, Estonia, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Russia, South Africa, Spain, Switzerland, United Kingdom