NCT00665366

Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder

A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated on Valproate or Lithium and in Need of Further Clinical Improvement

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 493 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.

Conditions

• Bipolar Disorder Mania

Interventions

Type	Name	Description
DRUG	Aripiprazole	5-, 10-, or 15-mg oral tablets in titrated doses for 12 weeks
DRUG	Placebo	Tablets, Oral, 0 mg, once daily, 12 weeks
DRUG	Lithium	Participant's ongoing dose
DRUG	Valproate	Participant's ongoing dose

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2008-04-23
• Last updated: 2013-12-02
• Results posted: 2013-02-04

Locations

73 sites across 13 countries: Austria, Czechia, France, Germany, Greece, Hungary, Italy, Poland, Romania, Russia, South Africa, Spain, Turkey (Türkiye)