Effectiveness and Safety of Transcutaneous Electrical Cranial-auricular Acupoint Stimulation (TECAS) for Patients With Mild-to-moderate Depression.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 470
- 试验地点
- 6
- 主要终点
- Clinical response at the end of treatment
研究概览
简要总结
One multi-center, randomized controlled clinical trial is designed to examine whether transcutaneous electrical cranial-auricular acupoint stimulation (TECAS) is non-inferior to the antidepressant drug (Escitalopram) in treating mild-to-moderate depression, to evaluate the depressive subtypes who are suitable for the TECAS treatment. To achieve this objective, 470 patients with mild-to-moderate depression will be recruited and assigned to receive TECAS treatment (n =235) or Escitalopram (n =235, 10-20mg/day, q.d.) for 8 weeks. The primary outcome is the Montgomery-Åsberg Depression Rating Scale (MADRS); other outcomes include the17-item Hamilton Depression Scale (HAMD-17), the Hamilton Anxiety Rating Scale (HAMA), Pittsburgh sleep quality index (PSQI), the Short Form 36 Health Survey and TCM diagnosis of depression. In addition, the safety index will be measured throughout the whole study.
详细描述
Depression is a common and costly disorder with high prevalence rate and high suicide rate. Antidepressants are the first-line treatments for depression. However, approximately 50% to 60% of the patients have not achieved adequate response following antidepressant treatment.
A large body of evidence well confirms that electro-acupuncture is effective in improving depression and reducing anti-depressant treatment-caused side effects, including pain, nausea, dizziness, fatigue, anxiety and sleep disturbance.
Based on the combination of ancient and modern literature and famous traditional Chinese medicine practitioners' experience, the Evidence-based Guidelines of Clinical Practice with Acupuncture and Moxibustion-Depression (ZJ/TE003-2014) recommended Baihui (DU20) and Yintang (DU29) as main acupoints in treating patients with depression via electro-acupuncture.
Our research team have completed a series of clinical trials, including electrical stimulation on cranial and auricular acupoints for treating depression, postpartum depression, post-stroke depression, and depression with somatic pain. These studies found that cranial-auricular acupoint stimulation, as well as transcutaneous electrical stimulation, can improve depressive symptoms and accompanying symptoms in patients with depression significantly.
Unlike traditional acupuncture, transcutaneous electrical stimulation does not need needles to penetrate the skin. It places electrodes on the skin of the corresponding acupoints. In this way, traumatic pain and fear of acupuncture can be avoided. And it is more easily accepted for patients and more convenient for clinical operation. Therefore, the investigators plan to build a novel transcutaneous electrical stimulation therapy--Transcutaneous electrical cranial-auricular acupoint stimulation (TECAS).
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
- •Primary diagnosis as mild to moderate depression；
- •Aged 18-70；
- •A score of MADRS ≥12 and <30 without suicide risk;
- •Participants to give consent and to cooperate with the treatment and data collection;
排除标准
- •Patients with severe diseases of heart, brain, liver, kidney or hematopoietic system, patients with acute diseases, infectious diseases and malignant tumours;
- •Patients who are unable to stop taking relevant drugs as required during the trial; (any other drug or non-drug treatment that affects depressive symptoms, including Chinese medicine, western medicine, and physical therapies et al.)
- •Patients with any history of psychosis or mania;
- •Patients with cognitive disorders or personality disorders;
- •Patients with serious suicidal ideation or behaviours.
研究组 & 干预措施
TECAS
Patients will receive transcutaneous electrical cranial-auricular acupoint stimulation (TECAS) daily.
干预措施: TECAS Procedure (Procedure)
TECAS
Patients will receive transcutaneous electrical cranial-auricular acupoint stimulation (TECAS) daily.
干预措施: Insomnia medication (Drug)
Anti-depressants
Each subject shall receive oral administration Escitalopram (10-20mg/day, q.d.), as prescribed by a clinical psychiatrist with respect to patients' conditions for 8 consecutive weeks.
干预措施: Escitalopram (Drug)
Anti-depressants
Each subject shall receive oral administration Escitalopram (10-20mg/day, q.d.), as prescribed by a clinical psychiatrist with respect to patients' conditions for 8 consecutive weeks.
干预措施: Insomnia medication (Drug)
结局指标
主要结局
Clinical response at the end of treatment
时间窗: 8 week
The responder is defined as a ≥50% reduction from the baseline MADRS or HAMD-17 at the end of treatment.
次要结局
- Changes from baseline in the Pittsburgh sleep quality index (PSQI)(Baseline, 2 week, 4 week, 8 week, 12 week)
- Changes from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) score(Baseline, 2 week, 4 week, 8 week, 12 week)
- Changes from baseline in the 17-item Hamilton Depression Scale (HAMD-17)(Baseline, 2 week, 4 week, 8 week, 12 week)
- Adverse events(Weeks 1-12)
- Changes from baseline in the Short Form 36 Health Survey(Baseline, 2 week, 4 week, 8 week, 12 week)
- Remission at the end of treatment(8 week)
- Changes from baseline in the Hamilton Anxiety Rating Scale (HAMA)(Baseline, 2 week, 4 week, 8 week, 12 week)
研究者
Prof. Zhang Zhang-Jin
Professor
The University of Hong Kong