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Effectiveness of Early Intervention With Fluoxetine in Enhancing Developmental Processes in Children With Autism (STAART Study 2)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00183339
First received: September 6, 2005
Last updated: February 25, 2008
Last verified: February 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Autistic Disorder
 Drug: Fluoxetine
Genetic: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled Trial of Fluoxetine in Preschool Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Feasibility and safety of conducting placebo control trial of fluoxetine [ Time Frame: Measured over 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Side effect and drop out evaluation [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: July 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
Participants will take the placebo
 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.
Experimental: B
Participants will take fluoxetine
 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.
Other Name: Prozac

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   30 Months to 58 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183339

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 25714
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Study Chair: Linmarie Sikich, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00183339     History of Changes
Other Study ID Numbers: U54 MH66418, U54 MH66673, U54 MH68172, DDTR BD-DD
Study First Received: September 6, 2005
Last Updated: February 25, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Autism

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013