|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
National Institute of Mental Health (NIMH) |
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00047697 |
Purpose
This 11-week study will examine the safety and effectiveness of the medication donepezil (Aricept®) compared to placebo for treating cognitive deficits in children and adolescents with Autism Spectrum Disorder.
| Condition | Intervention | Phase |
|
Autistic Disorder |
Drug: Donepezil HCl |
Phase II |
| MedlinePlus related topics: | Autism |
| ChemIDplus related topics: | Donepezil E 2020 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Donepezil HCl: Treating Cognitive Deficits in Autism |
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2002 |
| Estimated Study Completion Date: | July 2006 |
Children with autism spectrum disorder (ASD) often have impaired communication, problems with social interaction, and repetitive and stereotyped patterns of behavior. While most research has attempted to treat the behavioral deficits commonly associated with ASD, few studies have attempted to improve the core features of this disorder. A recent study found that donepezil HCl helped to improve speech production, attention span, and ability to express emotions in a group of children with autism. This study will provide an opportunity to conduct further testing of the effects of donepezil HCl on the cognitive deficits presumed to underlie the core features of ASD.
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.
Eligibility
| Ages Eligible for Study: | 8 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |||||
| Western Psychiatric Institute & Clinic | |||||
| Pittsburgh, Pennsylvania, United States, 15213 | |||||
| Principal Investigator: | Benjamin L. Handen, Ph.D. | University of Pittsburgh, School of Medicine, Department of Psychiatry |
More Information
| Study ID Numbers: | R21 MH64941, DSIR CT-M3 |
| First Received: | October 11, 2002 |
| Last Updated: | August 30, 2006 |
| ClinicalTrials.gov Identifier: | NCT00047697 |
| Health Authority: | United States: Federal Government |
|
|
|
|