Project Detail
Interagency Autism Coordinating Committee (IACC) logo
Office of Autism Research Coordination (OARC) logo

3/3-Atomoxetine placebo and parent training in autism  

While a sizeable subgroup of children with ASD also experience symptoms of over activity and inattention, there have been relatively few randomized clinical trials of pharmacology, especially in combination with behavioral therapy, for attention-deficit/hyperactivity (ADHD) in children with autism spectrum disorders (ASD). Studies involving stimulant medications have generally found poorer response rates and higher rates of intolerable side effects than in typically developing children with ADHD. Atomoxetine (Strattera) – a nonstimulant that affects the norepineprine system – was approved by the FDA in January 2003 for treatment of ADHD, but the relative effectiveness of atomoxetine in ASD and in combination with evidence-based behavioral interventions has not been well examined. In this project, researchers will perform a double-blind, placebo-controlled, 10-week parallel-group comparison of atomoxetine (ATX) versus placebo in ASD children with ADHD. In a separate but parallel study, the researchers will also assess the effectiveness of combining ATX treatment with a standard behavioral intervention paradigm known as Parent Management Training (PMT), which alone has been shown to be useful in managing ADHD symptoms. Children with ASD have been neglected in pharmacological research, placing an enormous burden on health care and educational systems. This trial has the potential to provide answers regarding optimal treatment (both behavioral and pharmacological) for a sizeable subgroup of children with ASD who experience symptoms of over activity and inattention. Project Status
ONGOING

2009

Funder National Institutes of Health
Fiscal Year Funding $277,200.00
Project Number 5R01MH083247-02
Principal Investigator Smith, Tristram
Received ARRA Funding? No
Strategic Plan Question Question 4: Which Treatments And Interventions Will Help? (Interventions)
Strategic Plan Objective New! Yellow dot: Objective has some degree of funding, but less than the recommended amount. 4SF. Launch five randomized controlled trials of interventions including biological signatures and other measures to predict response, and monitor quality of life and functional outcomes, in each of the following groups:
  • Five trials in infants and toddlers by 2013. IACC Recommended Budget: $30,000,000 over 5 years.
  • Three randomized controlled trials of interventions for school-aged children and/or adolescents by 2013. IACC Recommended Budget: $18,000,000 over 5 years.
  • Three trials for adults by 2014. IACC Recommended Budget: $18,000,000 over 5 years.
Federal or Private? Federal
Institution University of Rochester
State/Country New York
Web Link 1 3/3-Atomoxetine placebo and parent training in autism (External web link)
Web Link 2 No URL available.
Web Link 3 No URL available.
New! History/Related Projects 3/3-Atomoxetine placebo and parent training in autism | $277,198.00 | 2010 | 5R01MH083247-03
3/3-Atomoxetine placebo and parent training in autism | $271,708.00 | 2008 | R01MH083247-01