Treatment of Sleep Problems in Children With Autism Spectrum Disorder With Melatonin

We 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 sleep-wake cycle. Furthermore, we will examine whether MT is effective in improving sleep in children with ASD. Children with ASD experience high rates of sleep disturbances that potentially...

Date First Received: June 3, 2008

Last Updated: June 4, 2008

Verified by: Baylor College of Medicine, June 2008

Clinical Trial Phase: Phase 2/Phase 3 | Start Date: September 2007

Overall Status: Recruiting

Estimated Enrollment: 120

Brief Summary

Official Title: “Treatment of Sleep Problems in Children With Autism Spectrum Disorder With Melatonin: A Double-Blind, Placebo-Controlled Study.”

Condition Keyword(s):

Intervention(s):

We 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 sleep-wake cycle. Furthermore, we will examine whether MT is effective in improving sleep in children with ASD. Children with ASD experience high rates of sleep disturbances that potentially contribute to problems with thinking and behavior. It is unclear if changes in MT production cause sleep problems in children with ASD. MT is frequently used to treat these sleep problems; however, it has not been well established whether MT is an effective treatment. Our hypotheses concerning MT are: 1. Children with ASD and sleep problems will have a delayed sleep-wake cycle and/or decreased MT production; 2.

Treatment with MT will be associated with improved sleep and behavior. All subjects will be recruited from one of three sites: Baylor College of Medicine, Oregon Health & Science University and Columbia University. We will use a standardized questionnaire to determine whether the child has sleep problems. We will measure MT levels in saliva in ASD children with sleep problems and in a group of ASD children 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 randomized trial of three oral doses of MT (3, 6, 9 mg) and a placebo. Neither children nor investigators will know which doses are being given to which participants. We will determine whether treatment with MT helps children fall asleep faster and whether their behavior improves, as reported on standardized questionnaires.

Results from this study will inform the development of future trials of sleep-wake interventions and clinical guidelines for the use of MT to manage sleep problems in ASD.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: August 2010

Intervention(s) in this Clinical Trial

  • Drug: Melatonin
    • 3mg, 6mg, or 9mg, of liquid melatonin preparation, administered daily before bedtime.
  • Drug: Placebo
    • Liquid placebo

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • 3mg liquid melatonin, administered once daily before bedtime
  • Experimental: 2
    • 6mg liquid melatonin, administered once daily before bedtime
  • Experimental: 3
    • 9mg liquid melatonin, administered once daily before bedtime
  • Placebo Comparator: 4
    • 3ml placebo administered daily before bedtime

Outcome Measures for this Clinical Trial

Primary Measures

  • Sleep Latency, as measured by actigraphy
    • Time Frame: 5 weeks
      Safety Issue?: No
  • Improved Behavior, as measured by the Aberrant Behavior Checklist
    • Time Frame: 5 Weeks
      Safety Issue?: No

Secondary Measures

  • Total sleep time, as measured by actigraphy
    • Time Frame: 5 weeks
      Safety Issue?: No
  • Decreased number of awakenings, as measured using actigraphy
    • Time Frame: 5 weeks
      Safety Issue?: No
  • Improved behavioral subdomain scores, as measured by the Aberrant Behavior Checklist
    • Time Frame: 5 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • 1. Diagnosis of ASD
  • 2. Age greater than or equal to 4 or less than or equal to 9 years
  • 3. Current sleep problems, as defined as a composite score of greater than 41 on the

CSHQ

  • 4. Failed sleep hygiene, as described below
  • 5. Parents must be fluent in English in order to complete CSHQ and ABC, validated in English only
  • 6. Parents have given informed consent.

Exclusion Criteria:

  • 1. Current use of psychoactive medications (e.g. fluoxetine, methylphenidate, risperidone, lithium, etc.)
  • 2. Current or use within the last month of beta-blockers or melatonin
  • 3. Current use of sleep aids
  • 4. Presence of untreated medical problems that could otherwise explain sleep problems (e.g. obstructive sleep apnea, gastroesophageal reflux disease (GERD)) 5) Blindness.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 4 Years

Maximum Age for this Clinical Trial: 9 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Baylor College of Medicine

Overall Clinical Trial Officials and Contacts

Daniel G Glaze, M.D. Study Director Baylor College of Medicine  

Overall Contact: Bobbi Hopkins, M.D. 832-822-1764 bhopkins@bcm.tmc.edu

Related Publications

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Additional Information

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00691080

Study ID Number: 2003

ClinicalTrials.gov Identifier: NCT00691080

Health Authority: United States: Institutional Review Board

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