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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00183404 |
This study will determine the short- and long-term safety and effectiveness of the drug olanzapine (Zyprexa®) for reducing symptoms of autism in children.
Condition | Intervention | Phase |
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Autism |
Drug: Olanzapine |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Long-Term Olanzapine Treatment in Children With Autism |
Estimated Enrollment: | 40 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Participants will take open olanzapine for up to 20 additional weeks after phase 1.
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Drug: Olanzapine
Olanzapine tablets, dosed once or twice per day, dosage 2.5 to 20 mg per day
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Autism is a serious childhood disorder that can significantly impair functioning and development. Educational and psychosocial programs are standard treatments for autistic children, but drug therapy is often needed as well. Haloperidol is the drug most commonly prescribed for symptoms of autism. However, long-term administration of haloperidol has been associated with adverse effects such as blurred vision, constipation, and nausea. The investigation of alternative drug treatments is necessary. This study will determine whether the antipsychotic drug olanzapine may be a safe and effective alternative to haloperidol for treating symptoms of autism in children.
This study will last 36 weeks and will comprise 2 phases. In Phase I, participants will be randomly assigned to receive either olanzapine or placebo for 12 weeks. Participants who do not respond to treatment will complete their participation in the study. Participants who respond to their assigned Phase I treatment will continue onto Phase II. All Phase II participants will receive olanzapine daily for 6 months. Self-report scales and checklists will be used to assess participants after each phase; these measures will be completed by participants and their parents.
Ages Eligible for Study: | 3 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Richard P. Malone, MD | 215-831-4058 | rmalone@drexelmed.edu |
Contact: Melissa Lech, BSN | 215-831-4058 | mlech@drexelmed.edu |
United States, Pennsylvania | |
Drexel University College of Medicine at Friends Hospital | Recruiting |
Philadelphia, Pennsylvania, United States, 19124 | |
Contact: Richard P. Malone, MD 215-831-4058 rmalone@drexelmed.edu | |
Contact: Melissa Lech, BSN 215-831-4058 mlech@drexelmed.edu | |
Principal Investigator: Richard P. Malone, MD | |
Sub-Investigator: Mary A. Delaney, MD |
Principal Investigator: | Richard P. Malone, MD | Drexel University College of Medicine |
Responsible Party: | Drexel University College of Medicine ( Richard P. Malone, MD ) |
Study ID Numbers: | R01 MH73524, DDTR B2-NDA |
Study First Received: | September 13, 2005 |
Last Updated: | April 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00183404 |
Health Authority: | United States: Federal Government |
Drug Treatment Child Olanzapine |
Developmental Disabilities Child Development Disorders, Pervasive Mental Disorders Autistic Disorder |
Mental Disorders Diagnosed in Childhood Olanzapine Serotonin |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants |
Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |