Nuclear Magnetic Resonance Imaging Study of Treatment With Sertraline in Geriatric Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- HAM-D 17 (Hamilton Depression Rating Scale)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Depressed
Depressed subjects receive experimental drug
干预措施: Sertraline (Drug)
结局指标
主要结局
HAM-D 17 (Hamilton Depression Rating Scale)
时间窗: 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
时间窗: 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)
时间窗: 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)
次要结局
未报告次要终点
研究者
Brent Forester
Director, Mood Disorders Division, Geriatric Psychiatry Research Program
Mclean Hospital