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Aging Brain Changes, Executive Dysfunction and Depression (FA)

This study has been completed.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Forest Laboratories
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00918684
First received: June 9, 2009
Last updated: April 4, 2017
Last verified: April 2017
Results First Received: February 17, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Depression
Intervention: Drug: Escitalopram

  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
Participant Flow of the Overall Study

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
116 participants were consented and enrolled. 10 of these subjects did not participate in the washout/placebo phase.

Reporting Groups
  Description
Escitalopram

12-week open label with 2 week placebo period (14 weeks total)

Escitalopram: 10mg tab daily


Participant Flow for 2 periods

Period 1:   Two Week Drug Washout and Placebo Phase
    Escitalopram
STARTED   106 
COMPLETED   90 
NOT COMPLETED   16 
Placebo Reponder                16 

Period 2:   Treatment Phase
    Escitalopram
STARTED   90 
COMPLETED   65 
NOT COMPLETED   25 
Lack of Efficacy                6 
Lost to Follow-up                2 
Physician Decision                8 
Protocol Violation                1 
Withdrawal by Subject                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.
All subjects who entered the treatment phase

Reporting Groups
  Description
Escitalopram

12-week open label with 2 week placebo period (14 weeks total)

Escitalopram: 10mg tab daily


Baseline Measures
   Escitalopram 
Overall Participants Analyzed 
[Units: Participants]
 90 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      21  23.3% 
>=65 years      69  76.7% 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.82  (6.76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      51  56.7% 
Male      39  43.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1   1.1% 
Not Hispanic or Latino      89  98.9% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      2   2.2% 
Native Hawaiian or Other Pacific Islander      1   1.1% 
Black or African American      12  13.3% 
White      75  83.3% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   90 
Hamilton Scale for Depression [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 21.21  (4.51) 
[1] The Hamilton Scale for Depression 24 item total scores range from 0-76. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.
Mini Mental Status Examination (MMSE) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 28.08  (1.64) 
[1] MMSE total scores range from 0-30. Higher scores indicate better memory functioning (no cognitive impairment). Total scores are reported with no subscales.
WHODAS-II Disability Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 34.64  (10.56) 
[1] WHODAS II total scores can range from 0-100. Higher scores indicate greater severity of disability. Total scores are reported with no subscales.
Stroop Color-Word Test [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 32.77  (10.63) 
[1] Stroop Color-Word total scores can range from 0-100. Higher scores indicate better memory functioning (no cognitive impairment). Total scores are reported with no subscales.


  Outcome Measures
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1.  Primary:   Hamilton Depression Rating Scale.   [ Time Frame: 14 weeks (12th week of treatment) ]

2.  Primary:   WHODAS-II Disability Scale   [ Time Frame: 14 weeks (12th week of treatment) ]

3.  Primary:   Stroop Color-Word Test   [ Time Frame: 14 weeks (12th week of treatment) ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. George Alexopoulos, M.D.
Organization: Weill Cornell Medical College
phone: 914-997-5767
e-mail: galexopoulos@med.cornell.edu



Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00918684     History of Changes
Other Study ID Numbers: 0204005523
R01MH065653-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: June 9, 2009
Results First Received: February 17, 2017
Last Updated: April 4, 2017