CompletedPhase 3

Aripiprazole Open-Label, Safety and Tolerability Study

United States325 participantsStarted 2004-09

Plain-language summary

The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.

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: * Adolescent patients with schizophrenia, or child and adolescent patients with bipolar I disorder, manic or mixed episode Exclusion Criteria: * Patients with a co-morbid serious, uncontrolled systemic illness * Patients with a significant risk of committing suicide

What they're measuring

Percentage of Subjects Experiencing SAEs

Timeframe: Baseline and Week 23

Trial details

NCT IDNCT00102518

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-02

Results submitted2012-05-16

View on ClinicalTrials.gov More Schizophrenia trials