Effectiveness of Early Intervention With Fluoxetine in Enhancing Developmental Processes in Children With Autism (STAART Study 2)
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Autistic Disorder
Intervention: Fluoxetine (Drug); Placebo (Genetic)
Phase: Phase 3
Status: Completed
Sponsored by: National Institute of Mental Health (NIMH) Official(s) and/or principal investigator(s):
Linmarie Sikich, MD, Study Chair, Affiliation: University of North Carolina
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.
Clinical Details
Official title: A Randomized, Placebo-Controlled Trial of Fluoxetine in Preschool Children
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Feasibility and safety of conducting placebo control trial of fluoxetine
Secondary outcome: Side effect and drop out evaluation
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
Minimum age: 30 Months.
Maximum age: 58 Months.
Gender(s): Both.
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
Locations and Contacts
Mount Sinai School of Medicine, New York, New York 10029, United States
University of North Carolina, Chapel Hill, Chapel Hill, North Carolina 25714, United States
Additional Information
Starting date: July 2005
Ending date: February 2008
Last updated: February 25, 2008
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