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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
October 27, 2005
October 28, 2005
September 16, 2009
February 26, 2010
March 30, 2017
November 2004
August 2008   (Final data collection date for primary outcome measure)
  • HAM-D 17 (Hamilton Depression Rating Scale) [ Time Frame: baseline at study entry week 0 ]

    This is a depression severity rating scale measuring symptoms of depression including mood, sleep, appetite, energy, motivation, guilt, suicidal ideation, concentration, physical complaints, paranoia, anxiety, effect on daily functioning and awareness of illness.

    Scale is from 0 (no depression symptoms) up to a maximum of 66 (severe depression symptoms).

  • Geriatric Depression Scale [ Time Frame: baseline at study entry week 0 ]
    This is a depression severity rating scale measuring symptoms of depression. Scale is from 0 (no depression symptoms) up to a maximum of 15 (severe depression symptoms).
  • Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) [ Time Frame: at week 0 for both control and depressed, and at week 12 for depressed ]

    The primary outcome is a phosphorus magnetic resonance spectroscopy (31P-MRS) signal quantified using a spectral time-domain fitting program based on the Marquadt-Levenberg non-linear, least-squares algorithm, that incorporates prior knowledge of spectral peak assignments, chemical shifts and J-coupling constants. Least squares means were calculated for average total signal using linear mixed effects models. Results are expressed as a spectroscopic index.

    beta-nucleoside triphosphate (bNTP) Phosphocreatine (PCr) Total nucleoside triphosphate (NTP)

  • HAM-D weekly
  • Geriatric Depression Scale weekly
  • MRS at week 13
Complete list of historical versions of study NCT00245557 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Magnetic Resonance Imaging Study of Geriatric Depression
Nuclear Magnetic Resonance Imaging Study of Treatment With Sertraline in Geriatric Depression
The purpose of this study was to use Magnetic Resonance Images to further our understanding of predictors and markers of treatment response and non-response in geriatric depression. We hypothesized that concentrations of high energy metabolites would be lower in depressed elderly compared to non-depressed.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Major Depressive Disorder
Drug: Sertraline

Oral Sertraline Dosage started at 25 mg a day, with increases up to maximum dosage strength of 200 mg a day.

Duration of treatment was 12 weeks.

Other Name: Zoloft
  • No Intervention: Healthy Controls
    Healthy Controls undergo MRI and neuropsychological testing
  • Experimental: Depressed
    Depressed subjects receive experimental drug
    Intervention: Drug: Sertraline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
August 2008
August 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • DSM- IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) diagnostic criteria for major depressive disorder
  • Hamilton Depression Scale- 17 item version score of 18 or higher
  • Must speak English
  • Women must be post-menopausal

Exclusion Criteria:

  • A current or pervious psychiatric disorder other than MDD
  • A current unstable medical condition
  • A pacemaker or metal implant
  • History of alcohol or drug dependence or abuse within the past year
  • Current prescription of excluded medications
  • Use of a drug within the last 30 days that was not approved for use by governmental authorities.
  • If you or a family member works at McLean Hospital
Sexes Eligible for Study: All
55 Years to 89 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00245557
2004P-002540
No
Not Provided
Not Provided
Brent Forester, Mclean Hospital
Mclean Hospital
  • Pfizer
  • National Alliance for Research on Schizophrenia and Depression
Principal Investigator: Brent Forester, M.D Mclean Hospital
Mclean Hospital
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP