Donepezil HCl & Cognitive Deficits in Autism

Autistic Disorder Clinical Trial

Official title:

Donepezil HCl: Treating Cognitive Deficits in Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00047697
• Other study ID #: R21MH064941
• Secondary ID: R21MH064941DSIR
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2002
• Last updated: September 7, 2017
• Start date: October 2002
• Est. completion date: August 2006

Study information

• Verified date: September 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Autistic Disorder
• Cognition Disorders

Intervention

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.
• Placebo
Placebo used in placed of Donepezil HCL

Locations

Country	Name	City	State
United States	Western Psychiatric Institute & Clinic	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Assessment: TMT	TMT: Trial-Making Test. Time (sec) Range: 0 - 300. Lower = better	8 weeks
Primary	Cognitive Assessment: EOWVT Standard Score	Expressive One Word Vocabulary Test (standard score) Range: 55-140. Higher = better	8 weeks
Primary	Cognitive Assessment: CVLT	California Verbal Learning Test (percent of correct answers) Range: 0-100. Higher = better	8 weeks