Drug Treatment for Autism - Tabular View

Tracking Information

First Received Date ^ICMJE

October 11, 2002

Last Updated Date

October 13, 2008

Start Date ^ICMJE

October 2002

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cognitive assessment [ Time Frame: Measured at baseline and after 4 and 8 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00047697 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Drug Treatment for Autism

Official Title ^ICMJE

Donepezil HCl: Treating Cognitive Deficits in Autism

Brief 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.

Detailed 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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Autistic Disorder

Intervention ^ICMJE

Drug: Donepezil HCl

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2006

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

8 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00047697

Responsible Party

Benjamin L. Handen, PhD, University of Pittsburgh, School of Medicine, Department of Psychiatry

Study ID Numbers ^ICMJE

R21 MH64941, DSIR CT-M3

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Benjamin L. Handen, PhD

University of Pittsburgh, School of Medicine, Department of Psychiatry

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP