Magnetic Resonance Imaging Study of Geriatric Depression

This study has been completed.
Sponsor:
Collaborators:
Pfizer
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Brent Forester, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00245557
First received: October 27, 2005
Last updated: May 6, 2013
Last verified: May 2012
Results First Received: September 16, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Intervention: Drug: Sertraline

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Healthy Controls (Baseline) Healthy Controls undergo MRI and neuropsychological testing
Depressed (Baseline) Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.

Participant Flow:   Overall Study
    Healthy Controls (Baseline)     Depressed (Baseline)  
STARTED     17     26  
COMPLETED     11     10  
NOT COMPLETED     6     16  



  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.
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Reporting Groups
  Description
Healthy Controls (Baseline) Healthy Controls undergo MRI and neuropsychological testing
Depressed (Baseline) Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
Total Total of all reporting groups

Baseline Measures
    Healthy Controls (Baseline)     Depressed (Baseline)     Total  
Number of Participants  
[units: participants]
  17     26     43  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     1     11     12  
>=65 years     16     15     31  
Age  
[units: years]
Mean ± Standard Deviation
  72.6  ± 4.8     69.3  ± 10.7     70.6  ± 8.9  
Gender  
[units: participants]
     
Female     8     13     21  
Male     9     13     22  
Region of Enrollment  
[units: participants]
     
United States     17     26     43  



  Outcome Measures

1.  Primary:   HAM-D 17 (Hamilton Depression Rating Scale)   [ Time Frame: baseline at study entry week 0 ]

2.  Primary:   Geriatric Depression Scale   [ Time Frame: baseline at study entry week 0 ]
Results not yet posted.   Anticipated Posting Date:   02/2013   Safety Issue:   No

3.  Primary:   MRS (Magnetic Resonance Spectroscopy)   [ Time Frame: at week 13 ]
Results not yet posted.   Anticipated Posting Date:   02/2013   Safety Issue:   No


  Serious Adverse Events
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Time Frame 6 years, 2 months
Additional Description No text entered.

Reporting Groups
  Description
Healthy Controls (Baseline) Healthy Controls undergo MRI and neuropsychological testing
Depressed (Baseline) Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.

Serious Adverse Events
    Healthy Controls (Baseline)     Depressed (Baseline)  
Total, serious adverse events      
# participants affected / at risk     0/17 (0.00%)     0/26 (0.00%)  




  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