Efficacy and Safety of Electroacupuncture on Treating the First Episode of Mild to Moderate Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- 17-item Hamilton Depression Rating Scale (HDRS-17)
研究概览
简要总结
Depression is a disease that endangers the physical and mental health of all human beings. Only 30-40% of patients with initial episode depression are cured after treatment with antidepressants. Acupuncture is a widely recognized therapy to treat depression in clinical practice, and it can effectively relieve the depressive mood and improve related physical symtoms in patients with mild to moderate depression. This randomised controlled trial (RCT) is aimed to investigate the efficacy and safety of electroacupuncture (EA) in the treatment for patients with the first-episode of mild to moderate depression.
详细描述
Patients will be recruited from the outpatient clinics in Shanghai Municipal Hospital and Shanghai Mental Health Center by Wechat and posters. A total of 204 eligible patients will be randomly allocated to two groups by a randomized block design: the electroacupuncture (EA) group (receiving EA treatment and taking the placebo drugs), and the antidepressants group (receiving sham acupuncture and taking the escitalopram ). After a one-week baseline evalauation, participants will enter a 9-month observation period in this trial, with a 3-month intervention period and a 6-month follow-up period. The interventiuon period will last for 12 weeks, with 3 sessions of real or sham acupuncture treatment per week for the first 8 weeks, and 2 sessions per week for the remaining 4 weeks. The escitalopram or the placebo will be given to the patients at a set time once a week during the 12-week intervention period, with daily oral dose of 10mg or up to 20mg as the maximum dose. Excperts in the Shanghai Mental Health Center will help the participants to adjust the drug dosage during the intervention period. The primary outcome is the 17-item Hamilton Rating Depression Sclae (HRDS-17) at week 12. The secondary outcomes include the recovery rate and the remission rate of depression, the Patient Health Questionnaire(PHQ-9) and the Medical Outcomes Study 36-Item Short Form (SF-36). Adverse effects will be assessed by the Treatment Emergent Symptom Scale through the trial. The software SPSS Version 24.0 for Windows will be used to do the data analysis. All statistical analyses will be based on the intention-to-treat (ITT) population of all randomly assigned patients, with a 2-sided significance level of less than 0.05.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who meet the diagnostic criteria of depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
- •Participants whose HDRS-17 score is 17-25 (mild-to-moderate depression).
- •Participants who suffer from depression for the first time.
- •Patients who have not taken any previous antidepressants.
- •Patients who are assessed as low risk for suicide.
- •Participants who have not received acupuncture treatment for at least 1 year.
- •Participants who voluntarily agree with the investigation and sign a written informed consent form.
排除标准
- •Participants with secondary depressive disorders caused by organic diseases, medicine or psychotic disorders.
- •Participants who are in the depressive episode of bipolar disorder, or suffering from dysthymia, reactive depression and depressive syndrome caused by other diseases.
- •Participants who had severe organic brain diseases and other serious physical diseases.
- •Participants with a history of alcohol abuse or drug dependence.
- •Participants who have enrolled in other clinical trial within 1 months.
- •Pregnant or lactating women.
研究组 & 干预措施
the electroacupuncture group
the electroacupuncture and the placebo drug
干预措施: electroacupuncture (EA) treatment (Other)
the electroacupuncture group
the electroacupuncture and the placebo drug
干预措施: Placebo (Drug)
the drug group
the sham acupuncture and the drug Escitalopram
干预措施: sham acupuncture (SA) treatment (Other)
the drug group
the sham acupuncture and the drug Escitalopram
干预措施: Escitalopram 10mg (Drug)
结局指标
主要结局
17-item Hamilton Depression Rating Scale (HDRS-17)
时间窗: Week 12
The HDRS-17 is an observer-rating questionnaire with 17 items used to assess the symptoms of patients diagnosed as suffering from depressive states. Each item is rated in 3-point or 5-point scales. A higher total score indicates a higher depression level.
次要结局
- Recovery rate of depression(Week 12)
- HDRS-17(Week 4, week 8, week 16, week 24 and week 36)
- The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)(Week 4, week 8 and week 12)
- Drug dairy(Up to 12 weeks)
- Adverse events（AEs）(Up to 12 weeks)
- Remission rate of depression(Week 12)
- Patient Health Questionnaire(PHQ-9)(Week 4, week 8, week 16, week 24 and week 36)