NCT00102518

Aripiprazole Open-Label, Safety and Tolerability Study

A Multi-Center, Open-Label, Safety and Tolerability Study of Flexible-Dose Oral Aripiprazole (2 Mg-30 mg) in the Treatment of Adolescent Patients With Schizophrenia and Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 325 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Aripiprazole	2 to 30 mg/day orally (2, 5, 10, 15, 20, 25, or 30 mg/day); tablets in strengths of 2, 5, 10, and 15 mg were used to achieve desired doses

Timeline

• Start date: 2004-09-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2005-01-31
• Last updated: 2012-08-31
• Results posted: 2012-08-31

Locations

50 sites across 1 country: United States