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.1 site in 1 country325 target enrollmentSeptember 2004

ConditionsSchizophrenia Bipolar Disorder

InterventionsAripiprazole

DrugsAripiprazole

Overview

Phase: Phase 3
Intervention: Aripiprazole
Conditions: Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Enrollment: 325
Locations: 1
Primary Endpoint: Percentage of Subjects Experiencing SAEs
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

February 2007

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

NCT00102063 and NCT00110461 Subjects

All subjects had either completed or had withdrawn from the double-blind extension phase of study NCT00110461 (OPDC 31-03-240) and study NCT00102063 (OPDC 31-03-239).

Intervention: Aripiprazole

Outcomes

Primary Outcomes

Percentage of Subjects Experiencing SAEs

Time Frame: Baseline and Week 23

Percentage of Subjects Experiencing SAEs. The incidences of SAEs are summarized by system organ class in CT-8.5.1; by system organ class and MedDRA preferred term and by system organ class, MedDRA preferred term, and severity.

Secondary Outcomes

Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score(Baseline and Week 26)
Change in Young Mania Rating Scale (Y-MRS) Total Score(Baseline and Week 26)