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Trial record 2 of 6 for:    donepezil and autism

Donepezil HCl & Cognitive Deficits in Autism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00047697
First Posted: October 16, 2002
Last Update Posted: October 5, 2017
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.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh
Results First Submitted: March 30, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Autistic Disorder
Interventions: Drug: Donepezil HCl
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Donepezil HCL Subjects placed on 5 and 10 mg of donepezil
Placebo Subjects placed on 5 mg or 10 mg of placebo

Participant Flow:   Overall Study
    Donepezil HCL   Placebo
STARTED   18   16 
COMPLETED   18   14 
NOT COMPLETED   0   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Placebo Participants will start with 5 mg/day of placebo, then have their doses increased to 10 mg/day of placebo after 4 weeks.
Total Total of all reporting groups

Baseline Measures
   Donepezil HCL   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   16   34 
Age 
[Units: Years]
Mean (Full Range)
 11.6 
 (8.7 to 16.8) 
 11.8 
 (8.1 to 16.6) 
 11.7 
 (8.1 to 16.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1   5.6%      2  12.5%      3   8.8% 
Male      17  94.4%      14  87.5%      31  91.2% 
Cognitive Assessment: TMT [1] 
[Units: Seconds]
Mean (Standard Deviation)
 123.6  (56.5)   154.9  (77.8)   138.3  (66.5) 
[1] TMT: Trial-Making Test. Time (sec) Range: 0 - 300. Lower = better
Cognitive Assessment: EOWVT Standard score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 104.6  (22.4)   108.7  (17.0)   106.5  (19.9) 
[1] Expressive One Word Vocabulary Test (standard score) Range: 55-140. Higher = better
Cognitive Assessment: CVLT [1] 
[Units: Correct answers, percentage]
Mean (Standard Deviation)
 40.7  (14.1)   47.1  (10.3)   43.7  (12.3) 
[1] California Verbal Learning Test (percent of correct answers) Range: 0-100. Higher = better


  Outcome Measures
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1.  Primary:   Cognitive Assessment: TMT   [ Time Frame: 8 weeks ]

2.  Primary:   Cognitive Assessment: EOWVT Standard Score   [ Time Frame: 8 weeks ]

3.  Primary:   Cognitive Assessment: CVLT   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The trial may not have been long enough to obtain clinically significant effects


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Benjamin L. Handen, PhD
Organization: University of Pittsburgh
phone: 412-235-5445
e-mail: handenbl@upmc.edu



Responsible Party: Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00047697     History of Changes
Other Study ID Numbers: R21MH064941 ( U.S. NIH Grant/Contract )
DSIR CT-M3 ( Other Identifier: NIMH )
First Submitted: October 11, 2002
First Posted: October 16, 2002
Results First Submitted: March 30, 2015
Results First Posted: October 5, 2017
Last Update Posted: October 5, 2017