Study of Aripiprazole in Patients With Bipolar I Disorder

Completed · Phase 3

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT00257972

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

400

Starts

2004-10-01

Expected to finish

2007-12-01

Last updated by the study team

2013-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of bipolar I disorder, manic or mixed episode

You may not qualify if…

• First manic or mixed episode
• Allergic, intolerant, or unresponsive to lithium and valproate or to aripiprazole
• Participation in a previous clinical trial within the past month or ever participated in a trial with aripiprazole

Where it is running

• Local Institution — Riverside, California, United States
• Local Institution — Deerfield Beach, Florida, United States
• Local Institution — Jacksonville, Florida, United States
• Local Institution — Maitland, Florida, United States
• Local Institution — Hoffman Estates, Illinois, United States
• Local Institution — Oak Brook, Illinois, United States
• Local Institution — Newton, Kansas, United States
• Local Institution — Newton, Massachusetts, United States
• Local Institution — New York, New York, United States
• Local Institution — Staten Island, New York, United States
• Local Institution — Raleigh, North Carolina, United States
• Local Institution — Dayton, Ohio, United States
• Local Institution — Media, Pennsylvania, United States
• Local Institution — Norristown, Pennsylvania, United States
• Local Institution — Philadelphia, Pennsylvania, United States
• Local Institution — Columbia, South Carolina, United States
• Local Institution — Memphis, Tennessee, United States
• Local Institution — Austin, Texas, United States
• Local Institution — Bellevue, Washington, United States
• Local Institution — Epping, Victoria, Australia
• Local Institution — Rousse, Bulgaria
• Local Institution — Sofia, Bulgaria
• Local Institution — Varna, Bulgaria
• Local Institution — Brno-Bohunice, Czechia
• Local Institution — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.