Effectiveness of Acupuncture on Treating Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in scores on the Hamilton Depression Rating Scale, 17 items (HAM-D-17)
研究概览
简要总结
Acupuncture is a popular complementary/alternative therapy that has been in use for thousands of years for the treatment of various medical and psychiatric conditions, including Major Depressive Disorder (MDD). In this study, the investigators applied the investigators acupuncture-treatment-for-depression protocol, based on Traditional Chinese Medicine (TCM) principles for treating MDD, to depressed patients not taking any antidepressant medications (a protocol that the investigators previously piloted as a medication augmentation therapy for partial responders with MDD).
The investigators specifically investigated the efficacy, safety, and tolerability of this TCM-based protocol for such patients, as well as potential differences in outcomes between weekly vs. twice-weekly treatment. The investigators hypothesized that acupuncture monotherapy would be associated with a response rate of at least 50%, which the investigators defined as a decrease in depressive symptoms from the beginning to the end of the study of 50% or more, and that the response would be greater among patients who received acupuncture 2 times per week (vs. 1 time per week). The investigators also hypothesized that acupuncture would be associated with minimal side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has current or past DSM-IV MDD diagnosis based on SCID; AND current 17-Hamilton Rating Scale for Depression (BRSD) score of 14 or above
- •Age between 18-65
- •No treatment with antidepressant(s) in the past 3 months
- •If patient has received psychotherapy, no initiation or termination of therapy in the past 3 months.
排除标准
- •Patients with primary diagnosis other than Major Depressive Disorder, or any history of psychosis or mania.
- •Conditions that could make it difficult to conclusively determine that depressive symptoms were the result of MDD and not some other condition, including substance abuse or dependence within the last 6 months, medical conditions that could produce depression, including epilepsy, history of an abnormal EEG, severe head trauma, or stroke.
- •Serious uncontrolled medical conditions [e.g. poorly controlled diabetes, severe congestive heart failure], or other medical conditions that have not been stable for at least 3 months.
- •Electroconvulsive therapy (ECT) during the last year.
- •Current active suicidal or self-injurious potential necessitating immediate treatment.
- •Currently receiving concomitant Acupuncture Treatment, or any Acupuncture treatment in the past three months.
结局指标
主要结局
Change in scores on the Hamilton Depression Rating Scale, 17 items (HAM-D-17)
时间窗: Baseline and all acupuncture sessions (weekly) for 8 weeks
The HAM-D-17 is a clinician-rated assessment (structured interview) of patients' depressive symptoms. Questions focus on depressive symptoms during the past 7 days, and higher cumulative scores (possible responses to each item range from 0-4 or 0-2) indicate more severe depression.
次要结局
- Response to treatment, defined as a 50% or greater improvement in HAM-D-17 score compared to baseline(Baseline and all acupuncture sessions (weekly) for 8 weeks)
研究者
Albert Yeung
Director of Primary Care Research, Depression Clinical and Research Program
Massachusetts General Hospital