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Aripiprazole Open-Label, Safety and Tolerability Study

Information source: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia; Bipolar Disorder

Intervention: Aripiprazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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.

Clinical Details

Official title: 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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Subjects Experiencing SAEs

Secondary outcome:

Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score

Change in Young Mania Rating Scale (Y-MRS) Total Score

Eligibility

Minimum age: 10 Years. Maximum age: 17 Years. Gender(s): Both.

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

Locations and Contacts

Local Institution, Birmingham, Alabama, United States

Local Institution, Little Rock, Arkansas, United States

Local Institution, Costa Mesa, California, United States

Local Institution, Fresno, California, United States

Local Institution, Orange, California, United States

Local Institution, Riverside, California, United States

Local Institution, Rosemead, California, United States

Local Institution, Sacramento, California, United States

Local Institution, Temecula, California, United States

Local Institution, Washington, District of Columbia, United States

Local Institution, Altamonte Springs, Florida, United States

Local Institution, Ft. Lauderdale, Florida, United States

Local Institution, Hialeah, Florida, United States

Local Institution, Jacksonville, Florida, United States

Local Institution, Miami, Florida, United States

Local Institution, Orange City, Florida, United States

Local Institution, Tampa, Florida, United States

Local Institution, Atlanta, Georgia, United States

Local Institution, Honolulu, Hawaii, United States

Local Institution, Chicago, Illinois, United States

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Local Institution, Lexington, Kentucky, United States

Local Institution, Louisville, Kentucky, United States

Local Institution, Lake Charles, Louisiana, United States

Local Institution, Metairie, Louisiana, United States

Local Institution, New Orleans, Louisiana, United States

Local Institution, Somerville, Massachusetts, United States

Local Institution, Clinton, Michigan, United States

Local Institution, Kansas City, Missouri, United States

Local Institution, St. Charles, Missouri, United States

Local Institution, Elmsford, New York, United States

Local Institution, New York, New York, United States

Local Institution, Olean, New York, United States

Local Institution, Rochester, New York, United States

Local Institution, Chapel Hill, North Carolina, United States

Local Institution, Cleveland, Ohio, United States

Local Institution, Lyndhurst, Ohio, United States

Local Institution, Oklahoma City, Oklahoma, United States

Local Institution, Bala Cynwyd, Pennsylvania, United States

Local Institution, Philadelphia, Pennsylvania, United States

Local Institution, Memphis, Tennessee, United States

Local Institution, Bellaire, Texas, United States

Local Institution, DeSoto, Texas, United States

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Local Institution, Salt Lake City, Utah, United States

Local Institution, Kirkland, Washington, United States

Local Institution, Seattle, Washington, United States

Local Institution, Spokane, Washington, United States

Local Institution, Wauwatosa, Wisconsin, United States

Additional Information

Starting date: September 2004
Last updated: July 31, 2012

Page last updated: August 20, 2015

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