Aripiprazole Open-Label, Safety and Tolerability Study - Full Text View

Aripiprazole Open-Label, Safety and Tolerability Study

This study is ongoing, but not recruiting participants.

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

ChemIDplus related topics:

Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, 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
Estimated Study Completion Date:	April 2007

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
First Received:	January 29, 2005
Last Updated:	July 25, 2006
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 October 17, 2008