Early Intervention With Fluoxetine in Autism

Completed · Phase 2 · Has a placebo group

Conditions studied: Autistic Disorder

In brief

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.

Key facts

Study ID

NCT00183339

Run by

University of North Carolina, Chapel Hill

People needed

18

Starts

2005-07-01

Expected to finish

2008-02-01

Last updated by the study team

2014-03-26

Who can join

Age: 3 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of autism

You may not qualify if…

• 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

Where it is running

• Mount Sinai School of Medicine — New York, New York, United States
• University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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