Back to resultsPilot Study of Sleep Therapy and Biomarkers in Children With Autism Spectrum Disorders
Primary Purpose
Autism Spectrum Disorder
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Melatonin and Donepezil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Children, Melatonin, Donepezil, Sleep disorder
Eligibility Criteria
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
Sites / Locations
- Stony Brook University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group A
Group B
Arm Description
Melatonin and donepezil (melatonin 3mg and donepezil 1.25-5mg based on age/weight each night) or placebo for 15 weeks
Melatonin and donepezil (melatonin 3mg and donepezil 1.25-5mg based on age/weight each night) or placebo for 15 weeks
Outcomes
Primary Outcome Measures
Lethargy/Social Withdrawal
Measured by subscale of the Aberrant Behavior Checklist
Secondary Outcome Measures
Stereotypic Behavior
Measured by subscale of the Aberrant Behavior Checklist
Sleep quality
Measured by the Children's Sleep Habits Questionnaire
Clinician Global improvement
Measured by the Clinical Global Impressions
Parent Global improvement
Measured by the Parent Reported Global Impressions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02487082
Brief Title
Pilot Study of Sleep Therapy and Biomarkers in Children With Autism Spectrum Disorders
Official Title
Pilot Study of Sleep Therapy and Biomarkers in Children With Autism Spectrum Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
too few subjects enrolled
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
January 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism Spectrum Disorder, Children, Melatonin, Donepezil, Sleep disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Other
Arm Description
Melatonin and donepezil (melatonin 3mg and donepezil 1.25-5mg based on age/weight each night) or placebo for 15 weeks
Arm Title
Group B
Arm Type
Other
Arm Description
Melatonin and donepezil (melatonin 3mg and donepezil 1.25-5mg based on age/weight each night) or placebo for 15 weeks
Intervention Type
Drug
Intervention Name(s)
Melatonin and Donepezil
Other Intervention Name(s)
Aricept
Intervention Description
The duration depends on group assignment.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The duration depends on group assignment.
Primary Outcome Measure Information:
Title
Lethargy/Social Withdrawal
Description
Measured by subscale of the Aberrant Behavior Checklist
Time Frame
Every 5 weeks for a total of 5 times
Secondary Outcome Measure Information:
Title
Stereotypic Behavior
Description
Measured by subscale of the Aberrant Behavior Checklist
Time Frame
Every 5 weeks for a total of 5 times
Title
Sleep quality
Description
Measured by the Children's Sleep Habits Questionnaire
Time Frame
Every 5 weeks for a total of 5 times
Title
Clinician Global improvement
Description
Measured by the Clinical Global Impressions
Time Frame
Every 5 weeks for a total of 5 times
Title
Parent Global improvement
Description
Measured by the Parent Reported Global Impressions
Time Frame
Every 5 weeks for a total of 5 times
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Miller-Horn, MD, MS
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study of Sleep Therapy and Biomarkers in Children With Autism Spectrum Disorders
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