Magnetic Resonance Imaging Study of Geriatric Depression
Nuclear Magnetic Resonance Imaging Study of Treatment With Sertraline in Geriatric Depression
1 other identifier
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable major-depressive-disorder
Started Nov 2004
Typical duration for not_applicable major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 27, 2005
CompletedFirst Posted
Study publicly available on registry
October 28, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
February 26, 2010
CompletedMarch 30, 2017
March 1, 2017
3.8 years
October 27, 2005
September 16, 2009
March 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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).
baseline at study entry week 0
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).
baseline at study entry week 0
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)
at week 0 for both control and depressed, and at week 12 for depressed
Study Arms (2)
Healthy Controls
NO INTERVENTIONHealthy Controls undergo MRI and neuropsychological testing
Depressed
EXPERIMENTALDepressed subjects receive experimental drug
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mclean Hospitallead
- Pfizercollaborator
- National Alliance for Research on Schizophrenia and Depressioncollaborator
Study Sites (1)
McLean Hospital
Belmont, Massachusetts, 02478, United States
Related Publications (1)
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.
PMID: 26891040DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brent Forester MD
- Organization
- McLean Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Brent Forester, M.D
Mclean Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Mood Disorders Division, Geriatric Psychiatry Research Program
Study Record Dates
First Submitted
October 27, 2005
First Posted
October 28, 2005
Study Start
November 1, 2004
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
March 30, 2017
Results First Posted
February 26, 2010
Record last verified: 2017-03