Treatment With Exercise Augmentation for Depression (TREAD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Remission (Score of 12 or Less on Inventory for Depressive Symptomatology- Clinician-rated)
研究概览
简要总结
This study will assess the effectiveness of an exercise program in improving antidepressant medication treatment for individuals with major depressive disorder (MDD).
详细描述
Partial response to antidepressant treatment is common in people with MDD and is associated with significant morbidity and reduced quality of life. Pharmacological therapies have been used to augment the effect of antidepressants; however, such therapies are associated with a range of adverse effects. Studies indicate that exercise may be safe and effective in augmenting depression treatment. This study will determine whether exercise can complement selective serotonin reuptake inhibitor (SSRI) therapy in people with MDD who have residual symptoms of depression despite drug treatment.
Participants will be randomly assigned to either high frequency exercise or low frequency exercise for 12 weeks. Depression symptoms will be measured weekly. Quality of life and satisfaction with the study will also be measured. Depression scales and self-reports will be used to assess participants.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Major Depressive Disorder
- •Score of 14 or higher on the Hamilton Depression Scale (HAM-D)
- •8 to 12 weeks of SSRI treatment, with at least 6 weeks at adequate doses
- •Sedentary lifestyle
- •Physically capable of exercise
- •Body mass index (BMI) less than 40 kg/m2
- •Willing and able to comply with study requirements
排除标准
- •Significant cardiovascular disease or other medical conditions
- •Uncontrolled hypertension
- •Abnormal exercise stress test
- •Hematologic disorders
- •Comorbid disorders, including depression due to another comorbid condition, psychotic disorder, bipolar disorder, schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder (OCD)
- •Alcohol and/or substance abuse in the past 6 months
- •Hospitalization for mental illness within the past year
- •High suicide risk
- •Use of psychopharmacological or psychotherapeutic treatment other than SSRIs
- •Failure to respond to two or more adequate pharmacological treatments during the current depressive episode
- •Significantly elevated blood lipids
- •Pregnancy
研究组 & 干预措施
SSRI+ LD
A low dose aerobic exercise (LD) augmentation intervention to SSRI
干预措施: SSRI + LD (Behavioral)
SSRI+ PHD
A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI
干预措施: SSRI + PHD (Behavioral)
结局指标
主要结局
Percentage of Participants With Remission (Score of 12 or Less on Inventory for Depressive Symptomatology- Clinician-rated)
时间窗: 12 weeks
The primary outcome measure- percentage of participants with remission (score of 12 or less on Inventory for Depressive Symptomatology- Clinician-rated). The change over time in probability of remission (IDS-C30 score ≤ 12) was compared between groups using a generalized linear mixed model (GLMM)41 as implemented in SAS (Proc Glimmix; SAS Institute Inc, Cary, North Carolina).
次要结局
未报告次要终点
研究者
Madhukar H. Trivedi, MD
Professor of Psychiatry
University of Texas Southwestern Medical Center