Aripiprazole in Children and Adolescents With Bipolar I Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar Disorder

In brief

The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.

Key facts

Study ID

NCT00110461

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

296

Starts

2005-03-01

Expected to finish

2007-02-01

Last updated by the study team

2012-05-21

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features

You may not qualify if…

• Patients with certain other psychological disorders
• Patients with a co-morbid serious, uncontrolled systemic illness
• Patients with significant risk of committing suicide

Where it is running

• Local Institution — Little Rock, Arkansas, United States
• Local Institution — National City, California, United States
• Local Institution — Orange, California, United States
• Local Institution — Pasadena, California, United States
• Local Institution — Sacramento, California, United States
• Local Institution — San Diego, California, United States
• Local Institution — Stanford, California, United States
• Local Institution — Washington D.C., District of Columbia, United States
• Local Institution — Altamonte Springs, Florida, United States
• Local Institution — Hialeah, Florida, United States
• Local Institution — Jacksonville, Florida, United States
• Local Institution — Miami, Florida, United States
• Local Institution — North Miami, Florida, United States
• Local Institution — Tampa, Florida, United States
• Local Institution — Atlanta, Georgia, United States
• Local Institution — Smyrna, Georgia, United States
• Local Institution — Boise, Idaho, United States
• Local Institution — Chicago, Illinois, United States
• Local Institution — Libertyville, Illinois, United States
• Local Institution — Indianapolis, Indiana, United States
• Local Institution — Kansas City, Kansas, United States
• Local Institution — Newton, Kansas, United States
• Local Institution — Lexington, Kentucky, United States
• Local Institution — Baton Rouge, Louisiana, United States
• Local Institution — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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