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Sponsors and Collaborators: |
Neuropharm Autism Speaks |
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Information provided by: | Neuropharm |
ClinicalTrials.gov Identifier: | NCT00515320 |
The purpose of this study is to assess the effect of fluoxetine orally dissolving tablets (ODT) on the repetitive behaviors core domain in children and adolescents with Autistic Disorder. The study will also investigate the effect of fluoxetine on the improvement of symptoms and the effects on daily living of the patient's family.
Condition | Intervention | Phase |
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Autistic Disorder |
Drug: Fluoxetine Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Study Of Fluoxetine In Autism: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group 14-Week Study To Investigate The Effect Of Fluoxetine Orally Dissolving Tablet (ODT) On Repetitive Behaviors In Childhood And Adolescent Autistic Disorder. |
Enrollment: | 158 |
Study Start Date: | August 2007 |
Study Completion Date: | January 2009 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Fluoxetine: Experimental | Drug: Fluoxetine |
Placebo: Placebo Comparator | Drug: Placebo |
Ages Eligible for Study: | 5 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion criteria may apply.
United States, Arizona | |
Southwest Autism Research and Resource Centre | |
Phoenix, Arizona, United States, 85006 | |
United States, California | |
University of California Davis | |
Sacramento, California, United States, 95817 | |
United States, Florida | |
University of Florida, Department of Psychiatry | |
Gainesville, Florida, United States, 32611 | |
United States, Georgia | |
Institute for Behavioral Medicine | |
Smyrna, Georgia, United States, 30080 | |
United States, Illinois | |
University of Illinois | |
Chicago, Illinois, United States, 60637-1448 | |
AMR-Baber Research Inc. | |
Naperville, Illinois, United States, 60563 | |
United States, Massachusetts | |
Harvard Medical School | |
Medford, Massachusetts, United States, 02155 | |
United States, Michigan | |
Children's Hospital of Michigan | |
Detroit, Michigan, United States, 48201 | |
United States, Nevada | |
Center for Psychiatry and Behavioral Medicine | |
Las Vegas, Nevada, United States, 89128 | |
United States, New Jersey | |
CRCNJ | |
Voorhees, New Jersey, United States, 08043 | |
United States, New York | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 | |
Long Island Jewish Hospital | |
Bethpage, New York, United States, 11714 | |
United States, North Carolina | |
University of North Carolina | |
Chapel Hill, North Carolina, United States, 27514 | |
United States, Ohio | |
Ohio State University | |
Columbus, Ohio, United States, 43210 | |
United States, Pennsylvania | |
Western Psychiatric Institute and Clinic/ Merck Child Outpatient Clinic | |
Pittsburgh, Pennsylvania, United States, 15203 | |
United States, Texas | |
Red Oak Psychiatry Associates | |
Houston, Texas, United States, 77090 | |
United States, Washington | |
Seattle Children's Hosptial University of Washington | |
Seattle, Washington, United States, 98105-0371 |
Responsible Party: | Neuropharm ( Dr Michael Snape / Chief Scientific Officer ) |
Study ID Numbers: | NPL-2008-4-AUTUS-004 |
Study First Received: | August 10, 2007 |
Last Updated: | February 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00515320 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Autism children adolescent Fluoxetine |
Autistic Disorder Repetitive behavior SSRI Selective Serotonin Reuptake Inhibitor |
Developmental Disabilities Neurotransmitter Agents Psychotropic Drugs Serotonin Uptake Inhibitors Serotonin Child Development Disorders, Pervasive Fluoxetine |
Autistic Disorder Mental Disorders Mental Disorders Diagnosed in Childhood Antidepressive Agents, Second-Generation Autism Antidepressive Agents |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors Pharmacologic Actions Child Development Disorders, Pervasive Fluoxetine |
Pathologic Processes Serotonin Agents Autistic Disorder Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |