Nuclear Magnetic Resonance Imaging Study of Treatment With Sertraline in Geriatric Depression
Overview
- Phase
- Not Applicable
- Intervention
- Sertraline
- Conditions
- Major Depressive Disorder
- Sponsor
- Mclean Hospital
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- HAM-D 17 (Hamilton Depression Rating Scale)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Brent Forester
Director, Mood Disorders Division, Geriatric Psychiatry Research Program
Mclean Hospital
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
Arms & Interventions
Depressed
Depressed subjects receive experimental drug
Intervention: Sertraline
Outcomes
Primary Outcomes
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)