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Donepezil HCl & Cognitive Deficits in Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00047697
Recruitment Status : Completed
First Posted : October 16, 2002
Results First Posted : October 5, 2017
Last Update Posted : October 5, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Autistic Disorder Drug: Donepezil HCl Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Donepezil HCl: Treating Cognitive Deficits in Autism
Study Start Date : October 2002
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Donepezil HCl
Donepezil HCL 5 mg and 10 mg
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.
Other Name: Aricept

Placebo Comparator: Placebo
Drug: Placebo
Placebo used in placed of Donepezil HCL

Primary Outcome Measures :
  1. Cognitive Assessment: TMT [ Time Frame: 8 weeks ]
    TMT: Trial-Making Test. Time (sec) Range: 0 - 300. Lower = better

  2. Cognitive Assessment: EOWVT Standard Score [ Time Frame: 8 weeks ]
    Expressive One Word Vocabulary Test (standard score) Range: 55-140. Higher = better

  3. Cognitive Assessment: CVLT [ Time Frame: 8 weeks ]
    California Verbal Learning Test (percent of correct answers) Range: 0-100. Higher = better

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00047697

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United States, Pennsylvania
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
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Principal Investigator: Benjamin L. Handen, PhD University of Pittsburgh, School of Medicine, Department of Psychiatry
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Responsible Party: Benjamin L Handen, PhD, BCBA-D, Assistant Professor of Psychiatry & Pediatric, University of Pittsburgh Identifier: NCT00047697    
Other Study ID Numbers: R21MH064941 ( U.S. NIH Grant/Contract )
R21MH064941 ( U.S. NIH Grant/Contract )
DSIR CT-M3 ( Other Identifier: NIMH )
First Posted: October 16, 2002    Key Record Dates
Results First Posted: October 5, 2017
Last Update Posted: October 5, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We have no specific plan to share data at this time.
Additional relevant MeSH terms:
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Autistic Disorder
Cognition Disorders
Cognitive Dysfunction
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Neurocognitive Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents