Aripiprazole Open-Label, Safety and Tolerability Study

This study has been completed.

Sponsored by:	Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by:	Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:	NCT00102518

Purpose

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.

Condition	Intervention	Phase
Schizophrenia Bipolar Disorder	Drug: Aripiprazole	Phase III

MedlinePlus related topics: Bipolar Disorder Schizophrenia

Drug Information available for: Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Parallel Assignment, Safety Study
Official Title:	A Phase III Trial 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

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Study Start Date:	September 2004
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	10 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102518

Show 53 Study Locations

Sponsors and Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

More Information

Study ID Numbers:	31-03-241
Study First Received:	January 29, 2005
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00102518
Health Authority:	United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Open Label
Aripiprazole
Bipolar I Disorder, Manic or Mixed Episode

Study placed in the following topic categories:

Schizophrenia
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder

Mood Disorders
Psychotic Disorders
Aripiprazole
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Tranquilizing Agents
Pathologic Processes
Disease
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009