CompletedPhase 3

Aripiprazole in Children and Adolescents With Bipolar I Disorder

United States296 participantsStarted 2005-03

Plain-language summary

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.

Who can participate

Age range10 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features Exclusion Criteria: * Patients with certain other psychological disorders * Patients with a co-morbid serious, uncontrolled systemic illness * Patients with significant risk of committing suicide

What they're measuring

Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4

Timeframe: Baseline and Week 4

Trial details

NCT IDNCT00110461

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-02

Results submitted2011-08-11

View on ClinicalTrials.gov More Bipolar Disorder trials