The Role of Biological Stress Markers in Predicting Treatment Response to Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Change in Oxidized Phosphatidylcholines in plasma
研究概览
简要总结
The main objective of this study is to determine whether biological stress markers (Oxidized Phosphatidylcholines and Oxylipins) in the blood can be used to predict the efficacy of rTMS in the treatment of major depressive disorder (MDD). It is our goal to identify biomarkers that may be used to determine which patients will benefit from rTMS treatment. A second objective of this study is to measure any changes in stress markers that occur across the course of rTMS therapy.
详细描述
250 patients who have been prescribed repetitive transcranial magnetic stimulation (rTMS) therapy for the treatment of major depressive disorder will be recruited for this study. Prior to undergoing rTMS, patients will give a small blood sample. An additional blood sample will be given upon completion of rTMS treatment. 60 healthy control individuals will also be recruited to provide a one-time blood sample for comparison. Control individuals will not receive rTMS treatment.
Blood samples will be analysed for levels of Oxidized Phosphatidylcholines and Oxylipins. The investigators wish to determine whether there is a difference in the pre-treatment levels of stress markers between individuals who ultimately respond to rTMS and those who do not. Additionally, the investigators wish to determine whether there is a change in stress markers as a result of rTMS treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with a major depressive episode
- •Not actively receiving psychotherapy
排除标准
- •History of a psychotic episode
- •History of neurological illness
- •Head injury
- •Active alcohol or substance abuse
- •History of a seizure disorder
- •Control Subject Exclusion Criteria:
- •History of depression or psychiatric illness
- •History of a psychotic episode
- •History of neurological illness
- •Head injury
- •Active alcohol or substance abuse
- •History of a seizure disorder
结局指标
主要结局
Change in Oxidized Phosphatidylcholines in plasma
时间窗: 3 weeks
Change in Oxidized Phosphatidylcholine levels in blood plasma pre- and post-repetitive transcranial magnetic stimulation (rTMS) treatment for depression.
次要结局
未报告次要终点