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

Study Overview
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Brief Summary
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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.

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

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Drug: Melatonin and Donepezil
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>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<br>* The duration depends on group assignment.<br>* Other names: Aricept;Other: Placebo<br>* The duration depends on group assignment.<br>|
| Other: Group B<br>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<br>* The duration depends on group assignment.<br>* Other names: Aricept;Other: Placebo<br>* The duration depends on group assignment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lethargy/Social Withdrawal | Measured by subscale of the Aberrant Behavior Checklist | Every 5 weeks for a total of 5 times | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stereotypic Behavior | Measured by subscale of the Aberrant Behavior Checklist | Every 5 weeks for a total of 5 times | 
| Sleep quality | Measured by the Children's Sleep Habits Questionnaire | Every 5 weeks for a total of 5 times | 
| Clinician Global improvement | Measured by the Clinical Global Impressions | Every 5 weeks for a total of 5 times | 
| Parent Global improvement | Measured by the Parent Reported Global Impressions | Every 5 weeks for a total of 5 times | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism Spectrum Disorder, Children, Melatonin, Donepezil, Sleep disorder