Clinical and Neuroendocrine/Metabolic Benefits of Exercise in Treatment Resistant Depression (TRD): A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change from baseline on Hamilton Rating Scale for Depression-17 item (HRSD17)score
研究概览
简要总结
The objective of this study is to determine the effects of adjunct exercise in treatment resistant depression. The central hypothesis for the research is that adjunct exercise with usual care in Treatment Resistant Depression (TRD) will have significant effects in improving the psychiatric symptoms in comparison to usual care alone.
详细描述
Participants with treatment resistant depression will be recruited to participate in a 12-week clinical trial on the effects of adjunct moderate-intensity exercise versus usual care. Primary outcome measure will be reduction in baseline scores on Hamilton Depression Rating Scale (17 item). Secondary outcome measure will include reduction in baseline scores of clinical global impression severity, pittsburgh sleep quality index global score, scores on beck depression inventory, and improvement in actigraphic sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being sedentary (exercising less than 3 times/week for > 20 minutes at moderate/vigorous intensity for each bout)
- •Ability to come for supervised exercises up to 5 days/week.
- •On stable doses of medication or psychotherapy (within last 1 month) for underlying depression and willingness to continue on stable dose or therapy schedule during active phase of study participation, with the exception of during acute exacerbation of symptoms of psychiatric illness.
- •Being able to read, understand, and provide written informed consent.
排除标准
- •DSM-IV TR Axis I diagnosis of bipolar disorder, schizophrenia or schizophrenia spectrum disorder, or substance or alcohol abuse/dependence disorder (except nicotine dependence) in the past 12 months. Patients with current primary anxiety disorder will also be excluded.
- •Behavioral or personality disturbances, which may significantly interfere with study participation.
- •Evidence of acute suicidal risk.
- •Medical contraindication for physical exercise (significant orthopedic or cardiopulmonary disorder) that would prevent regular aerobic exercise. The American College of Sports Medicine criteria for risk stratification will be used and where indicated medical clearance for exercise will be obtained through the subject's primary care physician.
- •Pregnancy.
结局指标
主要结局
Change from baseline on Hamilton Rating Scale for Depression-17 item (HRSD17)score
时间窗: Baseline, 6 weeks, and 12 weeks
Hamilton Rating Scale for Depression-17 item (HRSD17, a well standardized measure of depression will be the primary measures of efficacy.
次要结局
- Reduction in baseline scores of clinical global impression severity(Baseline, 6 weeks, and 12 weeks)
- Change from baseline on Beck Depression Inventory-II score(Baseline, 6 weeks, 12 weeks)
- Change from baseline on Pittsburgh Sleep Quality Index (PSQI) global sleep quality score(baseline, 6 weeks, 12 weeks.)
研究者
Ravi Singareddy
Associate Proffesor
Milton S. Hershey Medical Center