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Magnetic Resonance Imaging Study of Geriatric Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00245557
First Posted: October 28, 2005
Last Update Posted: March 30, 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.
Collaborators:
Pfizer
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Brent Forester, Mclean Hospital
Results First Submitted: September 16, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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 
Overall Participants Analyzed 
[Units: Participants]
 17   26   43 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      1   5.9%      11  42.3%      12  27.9% 
>=65 years      16  94.1%      15  57.7%      31  72.1% 
Age 
[Units: Years]
Mean (Standard Deviation)
 72.6  (4.8)   69.3  (10.7)   70.6  (8.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8  47.1%      13  50.0%      21  48.8% 
Male      9  52.9%      13  50.0%      22  51.2% 
Region of Enrollment 
[Units: Participants]
     
United States   17   26   43 


  Outcome Measures
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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 ]

3.  Primary:   Phosphorus Magnetic Resonance Spectroscopy (31P-MRS)   [ Time Frame: at week 0 for both control and depressed, and at week 12 for depressed ]


  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