Status:
COMPLETED
Early Intervention With Fluoxetine in Autism
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Autistic Disorder
Eligibility:
All Genders
30-58 years
Phase:
PHASE2
Brief 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 proce...
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 chi...
Eligibility Criteria
Inclusion
- Diagnosis of autism
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00183339
Start Date
July 1 2005
End Date
February 1 2008
Last Update
March 26 2014
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Mount Sinai School of Medicine
New York, New York, United States, 10029
2
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 25714