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Sponsored by: |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
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Information provided by: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
ClinicalTrials.gov Identifier: | NCT00102518 |
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 |
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 |
Ages Eligible for Study: | 10 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Open Label Aripiprazole Bipolar I Disorder, Manic or Mixed Episode |
Schizophrenia Affective Disorders, Psychotic Mental Disorders Bipolar Disorder |
Mood Disorders Psychotic Disorders Aripiprazole Schizophrenia and Disorders with Psychotic Features |
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 |