Trial record 3 of 6 for:    donepezil and autism

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Stony Brook University
Sponsor:
Collaborator:
Korea Institute of Science and Technology
Information provided by (Responsible Party):
Jill Miller-Horn, Stony Brook University
ClinicalTrials.gov Identifier:
NCT02487082
First received: June 29, 2015
Last updated: June 30, 2015
Last verified: June 2015
  Purpose

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 Intervention Phase
Autism Spectrum Disorder
Drug: Melatonin and Donepezil
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Sleep Therapy and Biomarkers in Children With Autism Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • Lethargy/Social Withdrawal Subscale of the Aberrant Behavior Checklist [ Time Frame: Every 5 weeks for a total of 5 times ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stereotypic Behavior subscale of the Aberrant Behavior Checklist [ Time Frame: Every 5 weeks for a total of 5 times ] [ Designated as safety issue: No ]
  • Sleep quality from the Children's Sleep Habits Questionnaire [ Time Frame: Every 5 weeks for a total of 5 times ] [ Designated as safety issue: No ]
  • Global improvement from the Clinical Global Impressions [ Time Frame: Every 5 weeks for a total of 5 times ] [ Designated as safety issue: No ]
  • Global improvement from the Parent Reported Global Impressions [ Time Frame: Every 5 weeks for a total of 5 times ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Aricept
Other: Placebo
The duration depends on group assignment.
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 Name: Aricept
Other: Placebo
The duration depends on group assignment.

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 (including melatonin or donepezil). Children on these will have to discontinue them for 4 weeks before enrollment in the trial in order to establish an appropriate behavioral baseline, and agree to discontinue use for the duration of the trial.
  • Pregnancy and lactation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02487082

Contacts
Contact: Jill Miller-Horn, MD, MS 631-444-2599 Jill.Miller-Horn@stonybrookmedicine.edu
Contact: Angie Wong, MHS 631-444-9083 angie.wong@stonybrookmedicine.edu

Locations
United States, New York
Stony Brook University Recruiting
Stony Brook, New York, United States, 11794
Contact: Angie Wong, MHS    631-444-9083    angie.wong@stonybrookmedicine.edu   
Principal Investigator: Jill Miller-Horn, MD, MS         
Principal Investigator: Dennis Choi, MD, PhD         
Sponsors and Collaborators
Stony Brook University
Korea Institute of Science and Technology
Investigators
Principal Investigator: Jill Miller-Horn, MD, MS Stony Brook University
  More Information

No publications provided

Responsible Party: Jill Miller-Horn, Assistant Professor of Neurology and Pediatrics, Stony Brook University
ClinicalTrials.gov Identifier: NCT02487082     History of Changes
Other Study ID Numbers: 65708
Study First Received: June 29, 2015
Last Updated: June 30, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Stony Brook University:
Autism Spectrum Disorder
Children
Melatonin
Donepezil
Sleep disorder

Additional relevant MeSH terms:
Autistic Disorder
Donepezil
Child Development Disorders, Pervasive
Disease
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes
Melatonin
Antioxidants
Central Nervous System Agents
Central Nervous System Depressants
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015