Donepezil HCl & Cognitive Deficits in Autism

University of Pittsburgh

Status and phase

Completed

Phase 2

Conditions

Autistic Disorder

Treatments

Drug: Donepezil HCl

Drug: Placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00047697

R21MH064941 (U.S. NIH Grant/Contract)

DSIR CT-M3 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

34 patients

Sex

All

Ages

8 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Autism Spectrum Disorder (ASD)
Asperger's Disorder
IQ of 75 or above
Baseline assessment tests within the acceptable range

Exclusion criteria

Bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder
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