Treatment of Sleep Problems in Children With Autism Spectrum Disorder With Melatonin (REST)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2010 by Baylor College of Medicine.
Recruitment status was Recruiting

Sponsor:

Collaborators:

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

First received: June 3, 2008

Last updated: December 21, 2010

Last verified: December 2010

History of Changes

Purpose

The investigators 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, the investigators 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. The investigators will use a standardized questionnaire to determine whether the child has sleep problems. The investigators 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. The investigators 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 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Treatment of Sleep Problems in Children With Autism Spectrum Disorder With Melatonin: A Double-blind, Placebo-controlled Study.

Resource links provided by NLM:

MedlinePlus related topics: Autism Sleep Disorders

Drug Information available for: Melatonin

U.S. FDA Resources

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
Experimental: 1 3mg liquid melatonin, administered once daily before bedtime	Drug: Melatonin 3mg, 6mg, or 9mg, of liquid melatonin preparation, administered daily before bedtime.
Experimental: 2 6mg liquid melatonin, administered once daily before bedtime	Drug: Melatonin 3mg, 6mg, or 9mg, of liquid melatonin preparation, administered daily before bedtime.
Experimental: 3 9mg liquid melatonin, administered once daily before bedtime	Drug: Melatonin 3mg, 6mg, or 9mg, of liquid melatonin preparation, administered daily before bedtime.
Placebo Comparator: 4 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:

Diagnosis of ASD
Age greater than or equal to 4 or less than or equal to 9 years
Current sleep problems, as defined as a composite score of greater than 41 on the CSHQ
Failed sleep hygiene, as described below
Parents must be fluent in English in order to complete CSHQ and ABC, validated in English only
Parents have given informed consent.

Exclusion Criteria:

Current use of psychoactive medications (e.g. fluoxetine, methylphenidate, risperidone, lithium, etc.)
Current or use within the last month of beta-blockers or melatonin
Current use of sleep aids
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

Publications:

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Responsible Party:	Bobbi Hopkins, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00691080 History of Changes
Other Study ID Numbers:	2003
Study First Received:	June 3, 2008
Last Updated:	December 21, 2010
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

Additional relevant MeSH terms:

Sleep Disorders
Parasomnias
Autistic Disorder
Dyssomnias
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

Melatonin
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013

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