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Magnetic Resonance Imaging Study of Geriatric Depression

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sertraline
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Geriatric, MRI, Sertraline

Eligibility Criteria

55 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • McLean Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Healthy Controls

Depressed

Arm Description

Healthy Controls undergo MRI and neuropsychological testing

Depressed subjects receive experimental drug

Outcomes

Primary Outcome Measures

HAM-D 17 (Hamilton Depression Rating Scale)
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
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)
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)

Secondary Outcome Measures

Full Information

First Posted
October 27, 2005
Last Updated
March 1, 2017
Sponsor
Mclean Hospital
Collaborators
Pfizer, National Alliance for Research on Schizophrenia and Depression
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1. Study Identification

Unique Protocol Identification Number
NCT00245557
Brief Title
Magnetic Resonance Imaging Study of Geriatric Depression
Official Title
Nuclear Magnetic Resonance Imaging Study of Treatment With Sertraline in Geriatric Depression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
Collaborators
Pfizer, National Alliance for Research on Schizophrenia and Depression

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Geriatric, MRI, Sertraline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Controls
Arm Type
No Intervention
Arm Description
Healthy Controls undergo MRI and neuropsychological testing
Arm Title
Depressed
Arm Type
Experimental
Arm Description
Depressed subjects receive experimental drug
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
Zoloft
Intervention Description
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.
Primary Outcome Measure Information:
Title
HAM-D 17 (Hamilton Depression Rating Scale)
Description
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).
Time Frame
baseline at study entry week 0
Title
Geriatric Depression Scale
Description
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).
Time Frame
baseline at study entry week 0
Title
Phosphorus Magnetic Resonance Spectroscopy (31P-MRS)
Description
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)
Time Frame
at week 0 for both control and depressed, and at week 12 for depressed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brent Forester, M.D
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26891040
Citation
Harper DG, Joe EB, Jensen JE, Ravichandran C, Forester BP. Brain levels of high-energy phosphate metabolites and executive function in geriatric depression. Int J Geriatr Psychiatry. 2016 Nov;31(11):1241-1249. doi: 10.1002/gps.4439. Epub 2016 Feb 18.
Results Reference
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Magnetic Resonance Imaging Study of Geriatric Depression

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