The Efficacy and Cerebral Mechanism of Intradermal Acupuncture for Major Depressive Disorder: a Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in the Hamilton Depression Scale-17 (HAMD-17) Scores
研究概览
简要总结
Major depressive disorder (MDD) is highly prevalent, affecting nearly 4% of the global population. Pharmacotherapy is the frontline treatment recommended by the guideline, but it also has some limitations such as delayed onset, inadequate response, and drug resistance. Intradermal acupuncture (IA) is a method of using short indwelling needles retained under the skin to produce continuous stimulation for long-term efficacy. It has been reported that IA combination medication appears to be more valuable than medication alone in the treatment of MDD, however, there is a lack of high-quality clinical evidence.While several studies have proposed that manual or electroacupuncture can improve MDD symptoms by modulating brain networks, the cerebral mechanism of IA as superficial acupuncture for MDD has not been reported. Hence, investigators designed a multicentre randomized controlled trial to assess the clinical efficacy and safety of IA for MDD and preliminarily explore the potential therapeutic mechanisms for IA by functional magnetic resonance imaging (fMRI) .
详细描述
A total of 120 patients with MDD who meet the inclusion criteria will be included in the study. Participants will be randomly assigned 1:1:1 to the waiting list group (patients in this group will be treated with selective 5-hydroxytryptamine reuptake inhibitors (SSRIs) only), sham intradermal acupuncture combined with SSRIs (SIA) group and active intradermal acupuncture combined with SSRIs (AIA) group. The study will assess the efficacy and safety of intradermal acupuncture for MDD. In addition, investigator will explore the possible cerebral mechanisms by which IA exerts its antidepressant effects.
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
- 是
入选标准
- •Patients diagnosed with MDD according to the International Classification of Disease-10 (ICD-10);
- •Aged between 18 and 60 years (no limitation on gender);
- •Administration of SSRIs;
- •Patients undergoing MRI and MRS should be right-handed and free of traumatic brain injury, claustrophobia or metal implants;
- •Written informed consent is obtained by the person or guardian.
排除标准
- •ICD-10 diagnoses: schizophrenia, bipolar disorder, manic episode or other psychotic disorders; alcohol and drug addiction;
- •Significant skin lesions, severe allergic diseases, tumors, and severe or unstable internal diseases involving the cardiovascular, digestive, endocrine, or hematological system;
- •Acute suicidal tendency;
- •Allergy to adhesive tape and fear of intradermal acupuncture;
- •Pregnancy and lactation;
- •Mental retardation and difficulty cooperating with doctors.
- •Participating in other clinical trials.
研究组 & 干预措施
Waiting list group
This group will include 40 patients with MDD who will be treated with oral SSRIs only, the dosage of which will be determined by the psychiatrist. At the end of this trial, patients could choose 6 weeks' intradermal acupuncture treatments free of charge.
干预措施: SSRI (Drug)
SIA group
This group will include 40 patients with MDD who will be treated with sham intradermal acupuncture (SIA) combined with SSRIs. Acupoints related to MDD will be stimulated by acupuncturists and the dosage of oral SSRIs will be determined by the psychiatrist.
干预措施: SSRI (Drug)
SIA group
This group will include 40 patients with MDD who will be treated with sham intradermal acupuncture (SIA) combined with SSRIs. Acupoints related to MDD will be stimulated by acupuncturists and the dosage of oral SSRIs will be determined by the psychiatrist.
干预措施: SIA (Device)
AIA group
This group will include 40 patients with MDD who will be treated with active intradermal acupuncture (AIA) combined with SSRIs. Acupoints related to MDD will be stimulated by acupuncturists and the dosage of oral SSRIs will be determined by the psychiatrist.
干预措施: SSRI (Drug)
AIA group
This group will include 40 patients with MDD who will be treated with active intradermal acupuncture (AIA) combined with SSRIs. Acupoints related to MDD will be stimulated by acupuncturists and the dosage of oral SSRIs will be determined by the psychiatrist.
干预措施: AIA (Device)
结局指标
主要结局
Changes in the Hamilton Depression Scale-17 (HAMD-17) Scores
时间窗: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
The HAMD scale is the most commonly used in the clinical assessment of depression, including 17 items. The higher the score, the more severe the depression. 0-7 means no depressive symptoms, 8-17 means mild depression, 18-24 was divided into moderate depression, and 25-52 was divided into severe depression.
次要结局
- Changes in the Pittsburgh Sleep Quality Index (PSQI) Scores(Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up)
- Changes in the Self-Rating Depression Scale (SDS) Scores(Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.)
研究者
Xiaomei Shao
Professor
The Third Affiliated hospital of Zhejiang Chinese Medical University