Effectiveness of Early Intervention With Fluoxetine in Enhancing Developmental Processes in Children With Autism (STAART Study 2)
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 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|
- Feasibility and safety of conducting placebo control trial of fluoxetine [ Time Frame: Measured over 12 months ] [ Designated as safety issue: Yes ]
- Side effect and drop out evaluation [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2005|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Placebo Comparator: A
Participants will take the 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.
Participants will take 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
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.
|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|
|Study Chair:||Linmarie Sikich, MD||University of North Carolina, Chapel Hill|