Official Title: “A Randomized, Placebo-Controlled Trial of Fluoxetine in Preschool Children”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2008

Autism, a brain disorder that affects a small percentage of Americans, often results in a lifetime of impaired thinking, feeling, and social functioning.

The disorder generally becomes apparent in children by the age of 3. Autism typically affects a person's ability to communicate, form relationships with others, and respond appropriately to the external world. Some people with autism can function at a relatively high level, with speech and intelligence intact. Others have serious cognitive impairments and language delays, and some never speak. This study will assess the safety and effectiveness of treating autistic children with fluoxetine to enhance developmental processes in core areas impacted by autism.

This double-blind study will last a total of 12 months. Participants will be randomly assigned to receive either fluoxetine or placebo. Study visits will be held every two weeks for approximately the first 3 months, or until the dose of medication is stabilized. After this initial period, study visits will be held on a monthly basis, with telephone assessments conducted in the interim periods.

Intervention(s) in this Clinical Trial

• Drug: Fluoxetine
  • Between 2 mg per day and 20 mg per day of liquid fluoxetine will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule.
• Genetic: Placebo
  • Between 2 mg per day and 20 mg per day of liquid placebo will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: A
  • Participants will take the placebo
• Experimental: B
  • Participants will take fluoxetine

Primary Measures

• Feasibility and safety of conducting placebo control trial of fluoxetine
  • Time Frame: Measured over 12 months
    Safety Issue?: Yes

Secondary Measures

• Side effect and drop out evaluation
  • Time Frame: Measured at Month 12
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Months

Maximum Age for this Clinical Trial: 58 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Mental Health (NIMH)

Overall Clinical Trial Officials and Contacts

Linmarie Sikich, MD Study Chair The University of North Carolina, Chapel Hill  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00183339

Study ID Number: U54 MH66418

ClinicalTrials.gov Identifier: NCT00183339

Health Authority: United States: Federal Government