Controlled-Release Melatonin (Melatonin CR)for the Treatment of Impaired Sleep Maintenance (ISM) in 4-8 Year Old Children With Autism Spectrum Disorders (ASD).

0401-09-FB

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.

2010-03-04

2010-10-01

2010-10-01

Terminated

Early phase I

1

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.

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2023-09-08