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Melatonin CR for the Treatment of Impaired Sleep Maintenance in 4-8 Year Old Children With Autism Spectrum Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01033565
Recruitment Status : Terminated (Unsuccessful in recruiting appropriate subjects.)
First Posted : December 16, 2009
Results First Posted : September 9, 2013
Last Update Posted : September 9, 2013
Information provided by (Responsible Party):
Howard Needelman, MD, University of Nebraska

Brief Summary:
The purpose of this research is to see the effects (good and bad) of Melatonin CR on sleep in 4-8 year old children with autism spectrum disorders and sleep problems.

Condition or disease Intervention/treatment Phase
Sleep Disorder Drug: Natrol Phase 4

Detailed Description:
The title of this acute, open-label pilot study is "Controlled Release Melatonin (Melatonin CR) for the treatment of impaired sleep maintenance (ISM) in 4-8 year old children with autism spectrum disorders (ASD)." Maintenance of sleep is a significant challenge in the treatment of children with neurodevelopmental disabilities including ASDs. Night awakening or early morning waking can have detrimental effects on these children's daytime behavior and the functioning of their household. Sleep problems in the ASD population are generally managed first with behavioral interventions and, when these are not successful, pharmacologic therapy. Most medications effect sleep onset and not sleep maintenance. This study investigates the effectiveness of Melatonin CR for managing ISM in 4-8 year old children with ASD. Twenty patients will be recruited from the Developmental/Behavioral Pediatrics Clinic at the Munroe Meyer Institute at the University of Nebraska Medical Center. Inclusion criteria are male and female children ages 4-8 years with a diagnosis of an ASD, including Pervasive Developmental Disorder NOS (PDD, NOS), Asperger's Syndrome, or Autistic Disorder, parent/guardian consent for participation, stable psychotropic medication treatment for at least 4 weeks, and a documented history of ISM based on parent-report, somnolog and Child Sleep Habits Questionnaire (CSHQ), and a clinician rating of ≥4 (moderately ill) on the Clinical Global Impression-Severity (CGI-S) Scale. Patients will be excluded if they have been treated with Melatonin or Melatonin CR in the past month, failed treatment with Melatonin CR, or if they have a previously un-evaluated medical condition which may be causing the ISM. Following the completion of a somnolog and standardized questionnaires, the patients will be treated for 10-14 days with melatonin CR. Somnologs will be completed during treatment, and standardized parent questionnaires, CGI-S, and adverse event collection will be repeated at the end of Melatonin CR therapy. Response will be defined as a Clinical Global Impression-Improvement (CGI-I) score of 1 or 2 (much or very much improved). These will be compared to baseline ratings. Following the completion of the study protocol, all patients will continue to be followed in the Developmental Pediatrics clinic. Data from this acute pilot trial can be used to evaluate the appropriateness of a larger study to determine optimal therapy for patients with ASD and ISM.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Controlled-Release Melatonin (Melatonin CR)for the Treatment of Impaired Sleep Maintenance (ISM) in 4-8 Year Old Children With Autism Spectrum Disorders (ASD).
Study Start Date : December 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: Natrol
Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days
Drug: Natrol
5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime.
Other Name: Sustained release melatonin

Primary Outcome Measures :
  1. Clinical Global Impression-Improvement [ Time Frame: 2 weeks ]
    Assigns numerical score indicating level of improvement compared to baseline. Scale is rated from 1-7: 1= very much improved; 2= much improved; 3= minimally improved; 4= no change; 5= minimally worse; 6= much worse; 7= very much worse.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female children,
  • ages 4-8 years,
  • diagnosed with an ASD, including
  • Pervasive Developmental Disorder NOS (PDD, NOS),
  • Asperger's Syndrome, or
  • Autistic Disorder, and followed in the Munroe Meyer Developmental Pediatrics Clinic. Documented impaired sleep maintenance (ISM) based on parent-report and 7 day somnolog (sleep diary).
  • Clinician rating of 4 (moderately ill) or worse on CGI-S. Rating is based on the clinician's experience with evaluating and treating this patient population.
  • Previous discussion during a clinic appointment about sleep difficulties, including review of sleep hygiene and basic behavioral interventions/strategies.
  • Current problems of overnight awakenings recorded on the Children's Sleep Habits Questionnaire (CSHQ) despite behavioral intervention.
  • Stable psychotropic medication treatment for the past 4 weeks.

Exclusion Criteria:

Treatment with Melatonin or Melatonin CR during the past month or previous failed treatment with Melatonin CR.

Presence of a previously unevaluated medical condition which may be the etiology of the nighttime awakenings. There is no contraindication for use of Melatonin CR in patients with obstructive sleep apnea.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01033565

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United States, Nebraska
University of Nebraska Medical Center Munroe Meyer Institute
Omaha, Nebraska, United States, 68198-5380
Sponsors and Collaborators
University of Nebraska
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Principal Investigator: Howard Needelman, MD University of Nebraska

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Responsible Party: Howard Needelman, MD, Associate Professor, Pediatrics, University of Nebraska Identifier: NCT01033565    
Other Study ID Numbers: 401-09
First Posted: December 16, 2009    Key Record Dates
Results First Posted: September 9, 2013
Last Update Posted: September 9, 2013
Last Verified: September 2013
Keywords provided by Howard Needelman, MD, University of Nebraska:
Impaired sleep maintenance
Autism Spectrum Disorders
Additional relevant MeSH terms:
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Sleep Wake Disorders
Autism Spectrum Disorder
Pathologic Processes
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants