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Interagency Autism Coordinating Committee (IACC)
Autism Research Database
Office of Autism Research Coordination (OARC)
 
Project Element Element Description

Project Title

Project Title

3/3-Atomoxetine placebo and parent training in autism

Principal Investigator

Principal Investigator

Smith, Tristram

Description

Description

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.

Funder

Funder

National Institutes of Health

Fiscal Year Funding

Fiscal Year Funding

274428

Current Award Period

Current Award Period

2008-2013

Strategic Plan Question

Strategic Plan Question

Question 4: Which Treatments And Interventions Will Help?

Strategic Plan Objective

Strategic Plan Objective

Yellow dot: Objective has some degree of funding, but less than the recommended amount. 4SF. Launch 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: o Five trials in infants and toddlers by 2013. IACC Recommended Budget: $30,000,000 over 5 years. o Three trials in school-aged children and/or adolescents by 2013. IACC Recommended Budget: $18,000,000 over 5 years. o Three trials in adults by 2014. IACC Recommended Budget: $18,000,000 over 5 years.

Project Link

Project Link

3/3-Atomoxetine placebo and parent training in autism (External web link)

Institution

Institution

University of Rochester

State/Country

State/Country

New York

Project Number

Project Number

5R01MH083247-04

Federal or Private?

Federal or Private?

Federal

Received ARRA Funding?

Received ARRA Funding?

No

History/Related Projects

History/Related Projects

3/3-Atomoxetine placebo and parent training in autism | 263639 | 2012 | 5R01MH083247-05

 
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