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| Sponsor: | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Donepezil HCl: Treating Cognitive Deficits in Autism |
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2002 |
| Study Completion Date: | August 2006 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Medication |
Drug: 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.
|
| No Intervention: 2 Placebo |
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, PhD | University of Pittsburgh, School of Medicine, Department of Psychiatry |
More Information
| Responsible Party: | Benjamin L. Handen, PhD, University of Pittsburgh, School of Medicine, Department of Psychiatry |
| ClinicalTrials.gov Identifier: | NCT00047697 History of Changes |
| Other Study ID Numbers: | R21 MH64941, DSIR CT-M3 |
| Study First Received: | October 11, 2002 |
| Last Updated: | October 13, 2008 |
| Health Authority: | United States: Federal Government |
|
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders Donepezil Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |
