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Drug Treatment for Autism

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00047697
First received: October 11, 2002
Last updated: October 13, 2008
Last verified: October 2008
History of Changes
  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 2

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

Resource links provided by NLM:

MedlinePlus related topics: Autism
U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

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

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

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.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047697

Locations
United States, Pennsylvania
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Benjamin L. Handen, PhD University of Pittsburgh, School of Medicine, Department of Psychiatry
  More Information

No publications provided

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 23, 2013