Project Detail
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Office of Autism Research Coordination (OARC) logo

ACE Network: Early pharmacotherapy guided by biomarkers in autism  

This study is part of an Autism Centers of Excellence (ACE) Network. Previous research has shown that synthesis of the neurotransmitter serotonin is abnormal during critical periods of brain and synapse development in autistic children. The researchers hypothesize that one pharmacological approach to the treatment of autism is the use of serotonin agonists in children less than the age of six years. Following up on smaller pilot studies, this study is a randomized clinical trial of the serotonin agonist buspirone in a large group of young children with ASD. In this trial, researchers will test the safety and efficacy of buspirone in the treatment of core features of autism and associated behavioral dysfunction in young children with autism. Researchers will also employ a biomarker measure for serotonin synthesis capacity to assess patient differences in response to treatment. The researchers hypothesize that buspirone treatment effects on serotonin synthesis capacity will correlate with positive changes in social interaction, repetitive behavior, sensory dysfunction and anxiety. If buspirone is found to be safe and effective, it would represent a novel pharmacological treatment for core symptoms in ASDs. Project Status
ONGOING

2009

Funder National Institutes of Health
Fiscal Year Funding $100,000.00
Project Number 5U01NS061264-02
Principal Investigator Chugani, Diane
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 Wayne State University
State/Country Michigan
Web Link 1 ACE Network: Early pharmacotherapy guided by biomarkers in autism (External web link)
Web Link 2 No URL available.
Web Link 3 No URL available.
New! History/Related Projects ACE Network: Early pharmacotherapy guided by biomarkers in autism | $1,000,000.00 | 2010 | 5U01NS061264-03