Donepezil HCl & Cognitive Deficits in Autism

NCT00047697 | Completed Phase 2 Results DMC

• 2 other identifiers: R21MH064941DSIR CT-M3
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Autistic Disorder

Outcome Measures

Primary Outcomes (3)

• Cognitive Assessment: TMT

  TMT: Trial-Making Test. Time (sec) Range: 0 - 300. Lower = better

  8 weeks

• Cognitive Assessment: EOWVT Standard Score

  Expressive One Word Vocabulary Test (standard score) Range: 55-140. Higher = better

  8 weeks

• Cognitive Assessment: CVLT

  California Verbal Learning Test (percent of correct answers) Range: 0-100. Higher = better

  8 weeks

Study Arms (2)

Donepezil HCl

EXPERIMENTAL

Donepezil HCL 5 mg and 10 mg

Drug: Donepezil HCl

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Donepezil HCl DRUG

Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.

Also known as: Aricept

Donepezil HCl

Placebo DRUG

Placebo used in placed of Donepezil HCL

Placebo

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Western Psychiatric Institute & Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

The trial may not have been long enough to obtain clinically significant effects

Results Point of Contact

• Title: Benjamin L. Handen, PhD
• Organization: University of Pittsburgh

handenbl@upmc.edu

412-235-5445

Study Officials

• Benjamin L. Handen, PhD

  University of Pittsburgh, School of Medicine, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry & Pediatric

Study Record Dates

• First Submitted: October 11, 2002
• First Posted: October 16, 2002
• Study Start: October 1, 2002
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: October 5, 2017
• Results First Posted: October 5, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)