Autistic DisorderPhase 2NCT00047697
Donepezil HCl & Cognitive Deficits in Autism
A Phase 2 study testing Donepezil HCl in people with Autistic Disorder, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Donepezil HCl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Aug 2006
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Autism Spectrum Disorder (ASD)
- Asperger's Disorder
- IQ of 75 or above
- Baseline assessment tests within the acceptable range
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
Read the 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.
- Conditions
- Autistic Disorder
- Being tested
- Donepezil HCl, Placebo
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil HClDrug
Also called Aricept
Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.
PlaceboDrug
Placebo used in placed of Donepezil HCL
| Study group | Role | What they receive |
|---|---|---|
| Donepezil HCl | Experimental | Donepezil HCL 5 mg and 10 mg Receives: Drug: Donepezil HCl |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Assessment: TMT
TMT: Trial-Making Test. Time (sec) Range: 0 - 300. Lower = better
Measured: 8 weeks
Cognitive Assessment: EOWVT Standard Score
Expressive One Word Vocabulary Test (standard score) Range: 55-140. Higher = better
Measured: 8 weeks
Cognitive Assessment: CVLT
California Verbal Learning Test (percent of correct answers) Range: 0-100. Higher = better
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2002 (estimated)
- Study startOct 2002
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh
- Investigators
- Benjamin L. Handen, PhD, Principal investigator, University of Pittsburgh, School of Medicine, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047697
- Sponsor's protocol ID
- R21MH064941
- Other IDs
- R21MH064941, DSIR CT-M3
- Status last verified
- Sep 2017
- First submitted
- 11 Oct 2002
- Last updated
- 5 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: We have no specific plan to share data at this time.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donepezil HCl: Treating Cognitive Deficits in Autism
- ClinicalTrials.gov ID
- NCT00047697
- Acronym / sponsor ID
- R21MH064941
- Conditions
- Autistic Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2002
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 16 Oct 2002 (estimated)
- Results
- Posted 5 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donepezil HCl | Experimental | Drug: Donepezil HClDonepezil HCL 5 mg and 10 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Autism Spectrum Disorder (ASD)
- Asperger's Disorder
- IQ of 75 or above
- Baseline assessment tests within the acceptable range
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donepezil HClAlso: AriceptParticipants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks. | Drug | Donepezil HCl |
| PlaceboPlacebo used in placed of Donepezil HCL | Drug | Placebo |
Primary outcome
Cognitive Assessment: TMT
Time frame: 8 weeks
TMT: Trial-Making Test. Time (sec) Range: 0 - 300. Lower = better
Cognitive Assessment: EOWVT Standard Score
Time frame: 8 weeks
Expressive One Word Vocabulary Test (standard score) Range: 55-140. Higher = better
Cognitive Assessment: CVLT
Time frame: 8 weeks
California Verbal Learning Test (percent of correct answers) Range: 0-100. Higher = better
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. We have no specific plan to share data at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin L. Handen, PhD principal investigator
University of Pittsburgh, School of Medicine, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Donepezil HCl in people with Autistic Disorder, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Assessment: TMT (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.