Randomized Study of Fluoxetine in Children and Adolescents With Autism

NCT ID: NCT00004486


Title
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.
Details
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
Conditions
Autism
Keywords
autism, neurologic and psychiatric disorders, rare disease
Source
FDA Office of Orphan Products Development
Sponsors
Icahn School of Medicine at Mount Sinai
Status
Completed
Acronym
Last Updated
23 Mar 2015
URL
Official Link
Citations/Publications
Hollander E, Phillips A, Chaplin W, Zagursky K, Novotny S, Wasserman S, Iyengar R. A placebo controlled crossover trial of liquid fluoxetine on repetitive behaviors in childhood and adolescent autism. Neuropsychopharmacology. 2005 Mar;30(3):582-9.

Locations
United States