Autistic Disorder
Conditions
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.
Interventions
DRUGDonepezil 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.
DRUGPlacebo
Placebo used in placed of Donepezil HCL
Sponsors
National Institute of Mental Health (NIMH)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Assessment: TMT | 8 weeks | TMT: Trial-Making Test. Time (sec) Range: 0 - 300. Lower = better |
| Cognitive Assessment: EOWVT Standard Score | 8 weeks | Expressive One Word Vocabulary Test (standard score) Range: 55-140. Higher = better |
| Cognitive Assessment: CVLT | 8 weeks | California Verbal Learning Test (percent of correct answers) Range: 0-100. Higher = better |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Donepezil HCL 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. | 18 |
| Placebo Participants will start with 5 mg/day of placebo, then have their doses increased to 10 mg/day of placebo after 4 weeks. | 16 |
| Total | 34 |
Baseline characteristics
| Characteristic | Donepezil HCL | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 11.6 years | 11.8 years | 11.7 years |
| Cognitive Assessment: CVLT | 40.7 Correct answers, percentage STANDARD_DEVIATION 14.1 | 47.1 Correct answers, percentage STANDARD_DEVIATION 10.3 | 43.7 Correct answers, percentage STANDARD_DEVIATION 12.3 |
| Cognitive Assessment: EOWVT Standard score | 104.6 units on a scale STANDARD_DEVIATION 22.4 | 108.7 units on a scale STANDARD_DEVIATION 17 | 106.5 units on a scale STANDARD_DEVIATION 19.9 |
| Cognitive Assessment: TMT | 123.6 Seconds STANDARD_DEVIATION 56.5 | 154.9 Seconds STANDARD_DEVIATION 77.8 | 138.3 Seconds STANDARD_DEVIATION 66.5 |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 17 Participants | 14 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 16 |
| other Total, other adverse events | 0 / 18 | 0 / 16 |
| serious Total, serious adverse events | 0 / 18 | 0 / 16 |
Outcome results
Primary
Cognitive Assessment: CVLT
California Verbal Learning Test (percent of correct answers) Range: 0-100. Higher = better
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Donepezil HCl | Cognitive Assessment: CVLT | 50.2 percentage of correct answers | Standard Deviation 11 |
| Placebo | Cognitive Assessment: CVLT | 51.3 percentage of correct answers | Standard Deviation 14.7 |
Primary
Cognitive Assessment: EOWVT Standard Score
Expressive One Word Vocabulary Test (standard score) Range: 55-140. Higher = better
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Donepezil HCl | Cognitive Assessment: EOWVT Standard Score | 109.7 units on a scale | Standard Deviation 21 |
| Placebo | Cognitive Assessment: EOWVT Standard Score | 114.5 units on a scale | Standard Deviation 16.1 |
Primary
Cognitive Assessment: TMT
TMT: Trial-Making Test. Time (sec) Range: 0 - 300. Lower = better
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Donepezil HCl | Cognitive Assessment: TMT | 118.3 seconds | Standard Deviation 79.1 |
| Placebo | Cognitive Assessment: TMT | 104.7 seconds | Standard Deviation 53.4 |