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

October 11, 2002
October 13, 2008
October 2002
August 2006   (final data collection date for primary outcome measure)
Cognitive assessment [ Time Frame: Measured at baseline and after 4 and 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00047697 on ClinicalTrials.gov Archive Site
Not Provided
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Drug Treatment for Autism
Donepezil HCl: Treating Cognitive Deficits in Autism

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Autistic Disorder
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.
  • Experimental: 1 Medication
    Intervention: Drug: Donepezil HCl
  • No Intervention: 2 Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2006
August 2006   (final data collection date for primary outcome measure)

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
Both
8 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00047697
R21 MH64941, DSIR CT-M3
Not Provided
Benjamin L. Handen, PhD, University of Pittsburgh, School of Medicine, Department of Psychiatry
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Benjamin L. Handen, PhD University of Pittsburgh, School of Medicine, Department of Psychiatry
National Institute of Mental Health (NIMH)
October 2008

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