Trial | NCT02487082  Report issue

Official Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    12
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.
Study Started
Jun 30
2015
Primary Completion
Dec 31
2020
Study Completion
Jan 29
2021
Last Update
Apr 28
2021

Drug Melatonin and Donepezil

The duration depends on group assignment.

  • Other names: Aricept

Other Placebo

The duration depends on group assignment.

Group A Other

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

Group B Other

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

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
No Results Posted