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Sponsored by: |
Drexel University College of Medicine |
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Information provided by: | Drexel University |
ClinicalTrials.gov Identifier: | NCT00208533 |
This is a 6-week open pilot study of aripiprazole for the treatment of adolescents, aged 12 to 18 years, diagnosed with autism. Children who qualify for the study will be treated with aripiprazole for 6 weeks.
Treatment is provided at no cost.
Condition | Intervention | Phase |
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Autism |
Drug: Aripiprazole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Aripiprazole in Children With Autism: A Pilot Study |
Enrollment: | 11 |
Study Start Date: | February 2004 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 Open Label
Open Label Aripiprazole
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Drug: Aripiprazole
Aripiprazole 5 mg to 30mg, individually titrated
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Ages Eligible for Study: | 12 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Drexel University College of Medicine at Friends Hospital | |
Philadelphia, Pennsylvania, United States, 19124 |
Principal Investigator: | Richard P Malone, MD | Drexel University College of Medicine |
Responsible Party: | Drexel University College of Medicine ( Richard P. Malone, M.D. ) |
Study ID Numbers: | 02841 |
Study First Received: | September 13, 2005 |
Last Updated: | April 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00208533 History of Changes |
Health Authority: | United States: Institutional Review Board |
Autism Pervasive developmental disorder Aripiprazole Antipsychotic medication Adolescents |
Child Development Disorders, Pervasive Developmental Disabilities Tranquilizing Agents Mental Disorders Autistic Disorder Mental Disorders Diagnosed in Childhood |
Psychotropic Drugs Central Nervous System Depressants Aripiprazole Antipsychotic Agents Autism |
Tranquilizing Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Pharmacologic Actions Child Development Disorders, Pervasive |
Autistic Disorder Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Aripiprazole Central Nervous System Agents |