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Pilot Study of Sleep Therapy and Biomarkers in Children With Autism Spectrum Disorders

Sponsor
Stony Brook University (Other)
Overall Status
Terminated
CT.gov ID
NCT02487082
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
68
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test the combined effect of melatonin and donepezil on improving sleep and behavior in children with Autism Spectrum Disorders. Melatonin is a natural neurohormone that helps regulate sleep and wake cycles. Donepezil is used to improve mental function for people with Alzheimer's disease. Children with Autism Spectrum Disorders are more likely to have problems sleeping than other children. This difficulty has been linked to daytime behavioral problems and family stress.

Condition or Disease Intervention/Treatment Phase
  • Drug: Melatonin and Donepezil
  • Other: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Pilot Study of Sleep Therapy and Biomarkers in Children With Autism Spectrum Disorders
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Jan 29, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Group A

Melatonin and donepezil (melatonin 3mg and donepezil 1.25-5mg based on age/weight each night) or placebo for 15 weeks

Drug: Melatonin and Donepezil
The duration depends on group assignment.
Other Names:
  • Aricept

    • Other: Placebo
    The duration depends on group assignment.
    Other: Group B

    Melatonin and donepezil (melatonin 3mg and donepezil 1.25-5mg based on age/weight each night) or placebo for 15 weeks

    Drug: Melatonin and Donepezil
    The duration depends on group assignment.
    Other Names:
  • Aricept

    • Other: Placebo
    The duration depends on group assignment.

    Outcome Measures

    Primary Outcome Measures

    1. Lethargy/Social Withdrawal [Every 5 weeks for a total of 5 times]

      Measured by subscale of the Aberrant Behavior Checklist

    Secondary Outcome Measures

    1. Stereotypic Behavior [Every 5 weeks for a total of 5 times]

      Measured by subscale of the Aberrant Behavior Checklist

    2. Sleep quality [Every 5 weeks for a total of 5 times]

      Measured by the Children's Sleep Habits Questionnaire

    3. Clinician Global improvement [Every 5 weeks for a total of 5 times]

      Measured by the Clinical Global Impressions

    4. Parent Global improvement [Every 5 weeks for a total of 5 times]

      Measured by the Parent Reported Global Impressions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Both male and female children

    • Ages 4 to 17 1/2 years

    • Diagnosis with Autism Spectrum Disorder on the basis of the clinical judgment of an autism specialist, preferably using the Autism Diagnostic Observation Schedule or the Autism Diagnostic Interview-Revised.

    Exclusion Criteria:

    • Abnormal electroencephalogram in the past month

    • Cardiovascular problems

    • Asthma

    • Respiratory disease

    • Peptic ulcer disease

    • Renal or hepatic dysfunction (abnormal blood urea nitrogen/creatinine or 2 times elevated liver transaminases)

    • Urinary tract obstruction

    • Underweight (body mass index < 5th percentile compared to age and sex matched population)

    • Other serious illness

    • Use of any of the following drugs that might interact with study medications (anticholinergics, systemic corticosteroids, phenobarbital, peginterferon, beta-blockers or any drug that may cause arrhythmias). Drugs that induce or inhibit cytochrome P450 2D6 and cytochrome P450 3A4 (enzymes important for drug metabolism) will be allowed because any effects of such medications are likely to be lost in individual variability due to genetic polymorphisms.

    • Use of medications affecting sleep with a half-life of 7 days or more. [Children on medications affecting sleep with a half-life of less than 7 days (including melatonin and donepezil) are eligible if they agree to discontinue use for the duration of the trial.]

    • Pregnancy and lactation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stony Brook University Stony Brook New York United States 11794

    Sponsors and Collaborators

    • Stony Brook University

    Investigators

    • Principal Investigator: Jill Miller-Horn, MD, MS, Stony Brook University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jill Miller-Horn, Assistant Professor of Neurology and Pediatrics, Stony Brook University
    ClinicalTrials.gov Identifier:
    NCT02487082
    Other Study ID Numbers:
    • 65708
    First Posted:
    Jul 1, 2015
    Last Update Posted:
    Apr 28, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jill Miller-Horn, Assistant Professor of Neurology and Pediatrics, Stony Brook University
    Autism Spectrum Disorder
    Children
    Melatonin
    Donepezil
    Sleep disorder
    Additional relevant MeSH terms:
    Disease
    Autistic Disorder
    Autism Spectrum Disorder
    Child Development Disorders, Pervasive
    Melatonin
    Donepezil

    Study Results

    No Results Posted as of Apr 28, 2021