Randomized Study of Fluoxetine in Children and Adolescents With Autism
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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Study Start Date:||September 1998|
|Estimated Study Completion Date:||December 2002|
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.
Completion date provided represents the completion date of the grant per OOPD records
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004486
|United States, New York|
|Albert Einstein College of Medicine|
|Bronx, New York, United States, 10461|
|New York University Medical Center|
|New York, New York, United States, 10016|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Study Chair:||Eric Hollander||Icahn School of Medicine at Mount Sinai|