Intradermal Acupuncture Versus Sham Acupuncture and SSRI for Treating Adolescents With Major Depressive Disorder: a Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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 a prevalent mental illness characterised by influencing the health and quality of life of patients，often manifesting in individuals under the age of 18. It has been wildly confirmed that acupuncture alone or in combination with the applicable adjuvant therapy for MDD can not only relieve patients' physical symptoms, but also enhance sleep quality. Intradermal acupuncture, as an acceptable and long-lasting treatment modality, is the focus of this research. This study was conducted to investigate the efficacy of intradermal acupuncture in the treatment of MDD.
详细描述
This study will enroll a total of 120 adolescents with MDD who meet the inclusion criteria. 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 is aim to evaluate the efficacy of intradermal acupuncture for MDD and examine whether intradermal acupuncture reduces side effects and improves the efficacy of SSRIs for MDD.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with MDD according to the International Classification of Disease-10 (ICD-10); HAMD-17≥7
- •Aged between 12 and 17 years (no limitation on gender);
- •Take SSRI for at least two weeks;
- •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 difficult to cooperate 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. After 6 weeks, patients could choose 6 weeks' intradermal acupuncture treatments free of charge.
干预措施: SSRI (Drug)
SIA+SSRIs group
This group will include 40 patients with MDD who will be treated with sham intradermal acupuncture 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+SSRIs group
This group will include 40 patients with MDD who will be treated with sham intradermal acupuncture 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+SSRIs group
This group will include 40 patients with MDD who will be treated with active intradermal acupuncture 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+SSRIs group
This group will include 40 patients with MDD who will be treated with active intradermal acupuncture 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: [Time Frame: 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 Self-Rating Depression Scale (SDS) Scores(Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up)
- 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 Short Form 36 Questionnaire（SF-36）(Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up)
- Changes in the Patient Health Questionaire-9 (PHQ-9)(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