CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 302 enrolled
Drug / intervention
Aripiprazole tablet, 10 mg +2 moredrug
Likely dose
Aripiprazole 10 mg or 30 mg orally once daily for 42 daysAI-extracted
Key inclusion· 1
  • ✓Primary diagnosis of Schizophrenia
Key exclusion· 4
  • ✕Schizoaffective disorder
  • ✕Major depressive disorder
  • ✕Delirium
  • ✕Bipolar disorder

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

Search/NCT00102063
NCT00102063Phase 3Completed
CompareCT.gov

Aripiprazole in Adolescents With Schizophrenia

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jan 20, 2005·Updated Aug 10, 2012

In Brief

A Phase 3 clinical trial evaluating Aripiprazole tablet, 10 mg, Aripiprazole tablet, 30 mg, and 1 other intervention for Schizophrenia. Completed, enrolled 302 participants across 55 sites in 2 countries.

Detailed Summary

The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 20, 2005
Enrollment StartJul 1, 2004
Primary CompletionAug 1, 2006
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 21.4 years ago

Interventions

Aripiprazole tablet, 10 mgdrug

Aripiprazole tablet 10 mg po qd x 42 days

Aripiprazole tablet, 30 mgdrug

Aripiprazole tablet 30 mg po qd x 42 days

Placebo tabletdrug

Placebo tablet po qd x 42 days