Status:
COMPLETED
The Effect of Donepezil (Aricept(Registered Trademark)) on REM Sleep in Children With Autism
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Autism
Cognition Disorder
Eligibility:
All Genders
2-10 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will test whether donepezil (Aricept(Registered Trademark)), a drug that is approved by the Food and Drug Administration to treat Alzheimer's disease, can increase rapid eye movement (REM) ...
Detailed Description
Autism spectrum disorders are defined by aberrant development of communication and socialization in the presence of restrictive and/or repetitive behaviors. Recent epidemiologic studies have documente...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Diagnosis of autism spectrum disorder
- Male or female subjects, ages 2 through 10 years.
- Each legal guardian must have a level of understanding sufficient to agree to all required tests and examinations. Each legal guardian must understand the nature of the study.
- Each subject must be stable for at least 6 weeks on any medication or therapy regimen prior to entry into study and must have no newly (within 6 weeks) recognized or intolerable adverse effects from that medicine or therapy. No subjects will be asked to discontinue any medication in order to qualify for enrollment.
- EXCLUSION CRITERIA:
- Serious, unstable illnesses including, gastroenterologic, respiratory, cardiovascular endocrinologic, immunologic,or hematologic disease.
- Renal or hepatic dysfunction that would interfere with excretion or metabolism of donepezil as evidenced by increase above upper limits of normal for BUN/creatinine, or two-fold elevation of serum transaminases (ALT/SGPT, AST/SGOT) or gamma glutamate (GGT)
- Documented history of hypersensitivity or intolerance to donepezil or other piperidine derivative.
- Subjects must not be taking any medication known to affect REM sleep or that is contraindicated for co-administration with donepezil.
- Presence or history of neurological disorders, including seizure disorders.
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00695136
Start Date
June 1 2008
End Date
January 1 2011
Last Update
April 24 2013
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892