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Treatment of Sleep Problems in Children With Autism Spectrum Disorder With Melatonin (REST)
This study is currently recruiting participants.
Verified by Baylor College of Medicine, June 2008
Sponsors and Collaborators: Baylor College of Medicine
Autism Speaks
Oregon Health and Science University
Columbia University
The EMMES Corporation
Autism Treatment Network
Information provided by: Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00691080
  Purpose

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.


Condition Intervention Phase
Sleep Problems
Drug: Melatonin
Drug: Placebo
Phase II
Phase III

MedlinePlus related topics: Autism Sleep Disorders
Drug Information available for: Melatonin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title: Treatment of Sleep Problems in Children With Autism Spectrum Disorder With Melatonin: A Double-Blind, Placebo-Controlled Study.

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Sleep Latency, as measured by actigraphy [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Improved Behavior, as measured by the Aberrant Behavior Checklist [ Time Frame: 5 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total sleep time, as measured by actigraphy [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Decreased number of awakenings, as measured using actigraphy [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Improved behavioral subdomain scores, as measured by the Aberrant Behavior Checklist [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2007
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
3mg liquid melatonin, administered once daily before bedtime
Drug: Melatonin
3mg, 6mg, or 9mg, of liquid melatonin preparation, administered daily before bedtime.
2: Experimental
6mg liquid melatonin, administered once daily before bedtime
Drug: Melatonin
3mg, 6mg, or 9mg, of liquid melatonin preparation, administered daily before bedtime.
3: Experimental
9mg liquid melatonin, administered once daily before bedtime
Drug: Melatonin
3mg, 6mg, or 9mg, of liquid melatonin preparation, administered daily before bedtime.
4: Placebo Comparator
3ml placebo administered daily before bedtime
Drug: Placebo
Liquid placebo

  Eligibility

Ages Eligible for Study:   4 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691080

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

Locations
United States, New York
Columbia University Not yet recruiting
New York, New York, United States, 10032
Contact: Carl Bazil, M.D.     212-305-1742     Cwb11@columbia.edu    
Contact: Agnes Whitaker     212-543-5286     whitakea@childpsych.columbia.edu    
Principal Investigator: Carl Bazil, M.D.            
Sub-Investigator: Agnes Whitaker, M.D.            
United States, Oregon
Oregon Health & Sciences University Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Kyle Johnson, M.D.     503-418-5781     johnsoky@ohsu.edu    
Principal Investigator: Kyle Johnson, M.D.            
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Bobbi Hopkins, M.D.     832-822-1764     bhopkins@bcm.tmc.edu    
Contact: Gay Horelica     832-822-7388     gayh@bcm.tmc.edu    
Sub-Investigator: Daniel G Glaze, M.D.            
Principal Investigator: Bobbi Hopkins            
Sponsors and Collaborators
Baylor College of Medicine
Autism Speaks
Oregon Health and Science University
Columbia University
The EMMES Corporation
Autism Treatment Network
Investigators
Study Director: Daniel G Glaze, M.D. Baylor College of Medicine
  More Information

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Responsible Party: Baylor College of Medicine ( Bobbi Hopkins )
Study ID Numbers: 2003
Study First Received: June 3, 2008
Last Updated: June 4, 2008
ClinicalTrials.gov Identifier: NCT00691080  
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Melatonin
Sleep
Autism
ASD
Sleep problems in children with autism spectrum disorder

Study placed in the following topic categories:
Developmental Disabilities
Child Development Disorders, Pervasive
Signs and Symptoms
Mental Disorders
Autistic Disorder
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Dyssomnias
Sleep Disorders
Melatonin

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Depressants
Protective Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009