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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

Treatment of sleep problems in children with autism spectrum disorder with melatonin: A double-blind, placebo-controlled study

Principal Investigator

Principal Investigator

Glaze, Daniel

Description

Description

This study will examine whether sleep problems in children with autism spectrum disorder (ASD) are related to alterations in the production of melatonin (MT), a hormone that plays an important role in regulating the sleep-wake cycle. This study will also examine whether MT is effective in improving sleep in children with ASD. The two hypotheses that will be tested are: 1) Children with ASD and sleep problems will have a delayed sleep-wake cycle and/or decreased MT production compared with those without sleep problems; and 2) treatment with MT will be associated with improved sleep and behavior. Sleep disturbance will be measured using a standardized questionnaire. The MT levels will be measured in saliva in two groups of children with ASD both with and without sleep problems. Total 24-hour MT production will be determined from urine samples in these same two groups. Eligible participants will then be enrolled in a trial of three oral doses of MT (3, 6, 9 mg) and a placebo.

Funder

Funder

Autism Speaks

Fiscal Year Funding

Fiscal Year Funding

150000

Current Award Period

Current Award Period

na

Strategic Plan Question

Strategic Plan Question

Question 4: Which Treatments And Interventions Will Help?

Strategic Plan Objective

Strategic Plan Objective

Green dot: Objective has greater than or equal to the recommended funding. 4SA. Support at least three randomized controlled trials that address co-occurring medical conditions associated with ASD by 2010. IACC Recommended Budget: $13,400,000 over 3 years.

Project Link

Project Link

Treatment of sleep problems in children with autism spectrum disorder with melatonin: A double-blind, placebo-controlled study (External web link)

Institution

Institution

Baylor College of Medicine

State/Country

State/Country

Texas

Project Number

Project Number

2003

Federal or Private?

Federal or Private?

Private

Received ARRA Funding?

Received ARRA Funding?

No

History/Related Projects

History/Related Projects

Clinical trial: Treatment of sleep problems in children with autism spectrum disorder with melatonin: A double-blind, placebo-controlled study | 16227 | 2011 | 5M01RR000188-47
Treatment of sleep problems in children with autism spectrum disorder with melatonin: A double-blind, placebo-controlled study | 8775 | 2010 | 5M01RR000188-46
Treatment of sleep problems in children with autism spectrum disorder with melatonin: A double-blind, placebo-controlled study | 127500 | 2010 | 2003
Treatment of sleep problems in children with autism spectrum disorder with melatonin: A double-blind, placebo-controlled study | 6814 | 2009 | 5M01RR000188-45
Treatment of sleep problems in children with autism spectrum disorder with melatonin: A double-blind, placebo-controlled study | 150000 | 2008 | 2203
Treatment of sleep problems in children with autism spectrum disorder with melatonin: A double-blind, placebo-controlled study | 0 | 2011 | 2003

 
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