CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 325 enrolled
Drug / intervention
Aripiprazoledrug
Likely dose
Aripiprazole 2–30 mg orally once daily (flexible dosing; typical range 2, 5, 10, 15, 20, 25, or 30 mg/day)AI-extracted
Key inclusion· 2
  • ✓Adolescent patients with schizophrenia
  • ✓Child and adolescent patients with bipolar I disorder, manic or mixed episode
Key exclusion· 2
  • ✕Co-morbid serious, uncontrolled systemic illness
  • ✕Significant risk of committing suicide

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00102518
NCT00102518Phase 3Completed
CompareCT.gov

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

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jan 31, 2005·Updated Aug 31, 2012

In Brief

A Phase 3 clinical trial evaluating Aripiprazole for Schizophrenia and Bipolar Disorder. Completed, enrolled 325 participants across 50 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Bipolar Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 31, 2005
Enrollment StartSep 1, 2004
Primary CompletionFeb 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 21.4 years ago

Interventions

Aripiprazoledrug

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