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| Sponsor: | FDA Office of Orphan Products Development |
|---|---|
| Collaborator: |
Mount Sinai School of Medicine |
| Information provided by: | FDA Office of Orphan Products Development |
| ClinicalTrials.gov Identifier: | NCT00004486 |
Purpose
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 |
|---|---|
|
Autism |
Drug: fluoxetine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00004486 History of Changes |
| Other Study ID Numbers: | 199/14266, MTS-FDR001520, MTS-GCO-96-713 |
| Study First Received: | October 18, 1999 |
| Last Updated: | December 7, 2005 |
| Health Authority: | United States: Federal Government |
|
autism neurologic and psychiatric disorders rare disease |
|
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders Fluoxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |