Home
Search
Study Topics
Glossary
|
|
|
|
|
|
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 |
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 |
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. |
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
|
Ages Eligible for Study: | 4 Years to 9 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bobbi Hopkins, M.D. | 832-822-1764 | bhopkins@bcm.tmc.edu |
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 |
Study Director: | Daniel G Glaze, M.D. | Baylor College of Medicine |
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 |
Melatonin Sleep Autism ASD Sleep problems in children with autism spectrum disorder |
Developmental Disabilities Child Development Disorders, Pervasive Signs and Symptoms Mental Disorders Autistic Disorder |
Mental Disorders Diagnosed in Childhood Neurologic Manifestations Dyssomnias Sleep Disorders Melatonin |
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 |