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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
  Purpose
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.

Condition Intervention
Major Depressive Disorder Drug: Sertraline

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nuclear Magnetic Resonance Imaging Study of Treatment With Sertraline in Geriatric Depression

Resource links provided by NLM:


Further study details as provided by Brent Forester, Mclean Hospital:

Primary Outcome Measures:
  • 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)



Enrollment: 43
Study Start Date: November 2004
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Healthy Controls
Healthy Controls undergo MRI and neuropsychological testing
Experimental: Depressed
Depressed subjects receive experimental drug
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245557


Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Pfizer
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Brent Forester, M.D Mclean Hospital
  More Information

Responsible Party: Brent Forester, Director, Mood Disorders Division, Geriatric Psychiatry Research Program, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00245557     History of Changes
Other Study ID Numbers: 2004P-002540
First Submitted: October 27, 2005
First Posted: October 28, 2005
Results First Submitted: September 16, 2009
Results First Posted: February 26, 2010
Last Update Posted: March 30, 2017
Last Verified: March 2017

Keywords provided by Brent Forester, Mclean Hospital:
Depression
Geriatric
MRI
Sertraline

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs