Early Intervention With Fluoxetine in Autism

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a pilot study to evaluate the feasibility and safety of conducting a year long, double-blind, placebo-controlled trial of fluoxetine in pre-school children to enhance developmental processes in core areas impacted by autism.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Fluoxetine

Criteria

Inclusion Criteria:

• Diagnosis of autism

Exclusion Criteria:

• Diagnosis of Asperger Syndrome, Rett Syndrome, Childhood Disintegrative Disorder, or Pervasive Development Disorder-Not Otherwise Specified

• Informed that treatment with a selective serotonin reuptake inhibitor (SSRI) is medically inadvisable

• Need for ongoing psychotropic medication (except for diphenhydramine, clonidine, or melatonin for sleep)

• Recent use of stimulants within 5 days prior to enrollment

• Ongoing need for or recent use of most psychotropic medications within 14 days of enrollment

• Recent initiation of specialized educational, behavioral, or diet intervention for autism in the month prior to enrollment