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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

Mirtazapine treatment of anxiety in children and adolescents with pervasive developmental disorders

Principal Investigator

Principal Investigator

McDougle, Christopher

Description

Description

Pervasive developmental disorders (PDDs) are life-long childhood neurobiological disorders that cause marked problems with social interaction and communication. In addition to the core impairments in socialization and language, many persons with PDDs often experience high levels of anxiety. Little to no research has been done on treating anxiety symptoms in ASDs, yet preliminary studies suggest it is a common and disabling symptom in many persons. Currently used medications are frequently ineffective or cause troublesome adverse effects. The primary objective of this application is to conduct a preliminary placebo controlled trial of mirtazapine for the treatment of anxiety associated with PDDs. Mirtazapine is novel in that it has both noradrenergic and serotonergic properties. The central hypothesis of this project is that mirtazapine will improve anxiety when administered to children and adolescents with PDD. Thirty children and adolescents (ages 5-17 years) will be randomized to either mirtazapine (n=20) or placebo (n=10) and assessed over 10 weeks of treatment. Finding preliminary evidence of mirtazapine efficacy will be highly significant given the paucity of research involving anxiety in PDD. In addition to improving our understanding of anxiety and its treatment in PDD, results from this trial would be crucial in the development of a larger multi-site clinical trial. When completed, this study will be the first prospective trial of mirtazapine in ASDs, as well as one of the first to examine treatments for anxiety in ASDs. Furthermore, it will give important information about the utility of various outcome measures in measuring anxiety in ASDs.

Funder

Funder

Autism Speaks

Fiscal Year Funding

Fiscal Year Funding

94242

Current Award Period

Current Award Period

2010-2013

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. 4LC. Conduct at least one study to evaluate the safety and effectiveness of medications commonly used in the treatment of co-occurring conditions or specific behavioral issues in people with ASD by 2015. IACC Recommended Budget: $10,000,000 over 5 years.

Project Link

Project Link

Mirtazapine treatment of anxiety in children and adolescents with pervasive developmental disorders (External web link)

Institution

Institution

Indiana University

State/Country

State/Country

Indiana

Project Number

Project Number

5717

Federal or Private?

Federal or Private?

Private

Received ARRA Funding?

Received ARRA Funding?

No

History/Related Projects

History/Related Projects

Mirtazapine treatment of anxiety in children and adolescents with pervasive developmental disorders | 99974 | 2010 | 5717
Mirtazapine treatment of anxiety in children and adolescents with pervasive developmental disorders | 99993 | 2011 | 5717
Mirtazapine treatment of anxiety in children and adolescents with pervasive developmental disorders | 99971 | 2013 | 5717

 
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