Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
34 participants
INTERVENTIONAL
2002-10-31
2006-08-31
Brief Summary
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Detailed Description
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This study begins at Week 1 with a baseline assessment. Participants are then randomly assigned to either donepezil HCl or placebo. Participants will start with either a 5mg/day dose of donepezil HCl or placebo followed by a cognitive assessment after 4 weeks on this dose. Participants will then have their dose increased to 10mg/day. Another cognitive assessment will be given after 4 weeks on this dose.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Donepezil HCl
Donepezil HCL 5 mg and 10 mg
Donepezil HCl
Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.
Placebo
Placebo
Placebo
Placebo used in placed of Donepezil HCL
Interventions
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Donepezil HCl
Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.
Placebo
Placebo used in placed of Donepezil HCL
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Asperger's Disorder
* IQ of 75 or above
* Baseline assessment tests within the acceptable range
Exclusion Criteria
* Seizure disorder requiring the use of anticonvulsant medications
* Congenital rubella, cytomegalovirus, or tuberous sclerosis
* Certain medications prescribed for management of behavior (please contact the investigator for a complete list)
* Medications/preparations that are known to interact with donepezil HCl
* Significant medical illness, endocrinopathies, cardiovascular disease, or severe chronic malnutrition
* Pregnancy or sexually active females not using a reliable method of contraception
8 Years
17 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Benjamin L Handen, PhD, BCBA-D
Assistant Professor of Psychiatry & Pediatric
Principal Investigators
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Benjamin L. Handen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh, School of Medicine, Department of Psychiatry
Locations
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Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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