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Sponsors and Collaborators: |
FDA Office of Orphan Products Development Mount Sinai School of Medicine |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004486 |
OBJECTIVES: I. Evaluate the efficacy of fluoxetine on social and language deficits, global severity and compulsive dimensions of children and adolescents with autism. II. Assess the effectiveness of this treatment regimen on neurocognitive deficits in this patient population.
III. Compare the baseline compulsive severity and treatment outcome in these patients.
Condition | Intervention |
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Autism |
Drug: fluoxetine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment |
Estimated Enrollment: | 45 |
Study Start Date: | September 1998 |
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, crossover study. All patients receive oral placebo daily during week 0.
Patients are randomized to receive either oral fluoxetine or oral placebo daily on weeks 1-8. Patients then crossover to receive treatment on the other arm during weeks 12-20.
Ages Eligible for Study: | 5 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Meets diagnostic criteria for autism
--Prior/Concurrent Therapy--
Other:
--Patient Characteristics--
Hematopoietic: No significant hematopoietic disease
Hepatic: No prior or concurrent liver disease
Renal: No prior or concurrent kidney disease
Cardiovascular:
Neurological:
Other:
United States, New York | |
Albert Einstein College of Medicine | |
Bronx, New York, United States, 10461 | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 | |
New York University Medical Center | |
New York, New York, United States, 10016 |
Study Chair: | Eric Hollander | Mount Sinai School of Medicine |
Study ID Numbers: | 199/14266, MTS-FDR001520, MTS-GCO-96-713 |
Study First Received: | October 18, 1999 |
Last Updated: | December 7, 2005 |
ClinicalTrials.gov Identifier: | NCT00004486 History of Changes |
Health Authority: | United States: Federal Government |
autism neurologic and psychiatric disorders rare disease |
Developmental Disabilities Neurotransmitter Agents Psychotropic Drugs Rare Diseases Serotonin Uptake Inhibitors Serotonin Child Development Disorders, Pervasive |
Fluoxetine Mental Disorders Autistic Disorder Mental Disorders Diagnosed in Childhood Antidepressive Agents, Second-Generation Autism Antidepressive Agents |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors Pharmacologic Actions Child Development Disorders, Pervasive Fluoxetine |
Serotonin Agents Autistic Disorder Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |