Antidepressant Medication Plus Donepezil for Treating Late-life Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177671
First received: September 13, 2005
Last updated: January 31, 2013
Last verified: January 2013
Results First Received: February 18, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Depression
Dementia
Interventions: Drug: Escitalopram
Drug: Donepezil
Drug: Venlafaxine
Drug: Placebo
Drug: Duloxetine

  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
220 signed consent; 158 participants completed pre-randomization testing; 130 participants were randomized. Of these 130, 67 randomized to donepezil augmentation and 63 to placebo.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
28 enrolled participants were not randomized due to the following reasons: dementia (19), consent withdrawal (4), con-compliance with research procedures (3), supervening medical problems that precluded participation (2).

Reporting Groups
  Description
Donepezil Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
Placebo Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo

Participant Flow:   Overall Study
    Donepezil     Placebo  
STARTED     67     63  
Month 12     45     57  
Month 24     42     49  
COMPLETED     42     49  
NOT COMPLETED     25     14  
Withdrawal by Subject                 5                 6  
medical complications                 2                 0  
Adverse Event                 6                 0  
Physician Decision                 12                 8  



  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 Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
Placebo Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
Total Total of all reporting groups

Baseline Measures
    Donepezil     Placebo     Total  
Number of Participants  
[units: participants]
  67     63     130  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     0     0  
>=65 years     67     63     130  
Age  
[units: years]
Mean ± Standard Deviation
  73.1  ± 6.5     73.9  ± 5.8     73.5  ± 6.2  
Gender  
[units: participants]
     
Female     49     51     100  
Male     18     12     30  
Region of Enrollment  
[units: participants]
     
United States     67     63     130  



  Outcome Measures
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1.  Primary:   Global Cognitive Performance   [ Time Frame: Measured at baseline and Years 1 and 2 in maintenance ]

2.  Primary:   Cognitive Instrumental Activities of Daily Living (IADL)   [ Time Frame: baseline, year 1 and year 2 ]

3.  Primary:   Number of Participants With Recurrence of Major Depression   [ Time Frame: 2 years ]

4.  Post-Hoc:   Percentage of Participants With Mild Cognitive Impairment Converting to Dementia.   [ Time Frame: 2 year ]


  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
Observations about dementia conversion rates were obtained from post hoc subgroup analyses of participants with mild cognitive impairment (N=57) and participants with normal cognition at time of randomization (N=63).


  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: Charles F. Reynolds III, MD
Organization: University of Pittsburgh
phone: 412-246-6414
e-mail: reynoldscf@upmc.edu


Publications:
Publications automatically indexed to this study:

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177671     History of Changes
Other Study ID Numbers: R01 MH043832-03, R01MH043832, 0312018, DATR A4-GPS
Study First Received: September 13, 2005
Results First Received: February 18, 2011
Last Updated: January 31, 2013
Health Authority: United States: Federal Government