Magnetic Resonance Imaging Study of Geriatric Depression

Study Overview
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Brief Summary
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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.

Official Title
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Nuclear Magnetic Resonance Imaging Study of Treatment With Sertraline in Geriatric Depression

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Sertraline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Healthy Controls<br>Healthy Controls undergo MRI and neuropsychological testing | |
| Experimental: Depressed<br>Depressed subjects receive experimental drug | Drug: Sertraline<br>* 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.<br>* Other names: Zoloft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Geriatric, MRI, Sertraline