Intradermal Needle Therapy for Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in the Hamilton Depression Scale-17 (HAMD-17)
研究概览
简要总结
Major depressive disorder (MDD) is a common mental disorder that affects patients' physical health and quality of life. Although traditional acupuncture therapy has certain advantages in improving MDD, there are still some limitations, such as being time-consuming and some people having a fear of acupuncture. Therefore, intradermal needle therapy will be chosen in the treatment of MDD in this study, which is more convenient, shallow needling, and gentle than traditional acupuncture therapy. The study is designed to investigate the therapeutic effect and safety of intradermal needles for MDD.
详细描述
A total of 120 participants with MDD who meet the inclusion criteria will be included in the study. Participants will be randomly divided into the SSRIs + acupuncture group, acupuncture + placebo group, and SSRIs + sham acupuncture group. This study will evaluate the efficacy and safety of the intradermal needle for MDD and investigate whether the intradermal needle reduces side effects and increases the efficacy of selective serotonin reuptake inhibitors (SSRIs) antidepressants for MDD. Furthermore, the study will demonstrate whether the intradermal needle has a synergistic effect with SSRIs on the treatment of 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 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should meet the diagnostic criteria of the International Classification of Diseases 10th Edition (ICD-10) diagnostic criteria for depression and are evaluated as moderate or severe MDD according to the severity of depression;
- •12 ≤ age ≤60, male or female;
- •Participants have clear consciousness and could communicate with others normally;
- •Participants could understand the full study protocol and have high adherence. Written informed consent is signed by themselves or their lineal kin (for minor participants, their guardian should sign the informed consent form for them).
排除标准
- •Participants with serious primary diseases of cardiovascular, respiratory, digestive, urinary, hematological, endocrine, neurological disease, and other serious primary diseases, and the disease cannot be effectively controlled clinically;
- •Major depressive disorders caused by organic mental disorders, schizophrenia, bipolar disorder, psychoactive substances, and non-addictive substances;
- •Participants with suicidal tendencies;
- •Pregnant or lactating participants;
- •Participants taking other antidepressants that were not SSRIs or the pharmacological effects of such antidepressants have not been cleared;
- •Participants with intellectual disabilities who cannot cooperate with the questionnaire survey;
- •Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape;
- •Participants are participating in other trials.
研究组 & 干预措施
acupuncture + SSRIs group
This group will include 40 patients with MDD who will be treated with acupuncture and SSRIs antidepressants. Acupoints related to MDD will be stimulated. The oral dose of SSRIs antidepressants will be determined by the clinical specialist.
干预措施: SSRIs (Drug)
acupuncture + SSRIs group
This group will include 40 patients with MDD who will be treated with acupuncture and SSRIs antidepressants. Acupoints related to MDD will be stimulated. The oral dose of SSRIs antidepressants will be determined by the clinical specialist.
干预措施: acupuncture (Procedure)
acupuncture + placebo group
This group will include 40 patients with MDD who will be treated with acupuncture and a placebo. Acupoints related to MDD will be stimulated. The oral dose of SSRIs antidepressants will be determined by the clinical specialist.
干预措施: acupuncture (Procedure)
acupuncture + placebo group
This group will include 40 patients with MDD who will be treated with acupuncture and a placebo. Acupoints related to MDD will be stimulated. The oral dose of SSRIs antidepressants will be determined by the clinical specialist.
干预措施: placebo (Drug)
sham acupuncture + SSRIs group
This group will include 40 patients with MDD who will be treated with sham acupuncture and SSRIs antidepressants. The sham acupuncture will be needled on the points 1cm lateral to acupoints. The oral dose of SSRIs antidepressants will be determined by the clinical specialist.
干预措施: SSRIs (Drug)
sham acupuncture + SSRIs group
This group will include 40 patients with MDD who will be treated with sham acupuncture and SSRIs antidepressants. The sham acupuncture will be needled on the points 1cm lateral to acupoints. The oral dose of SSRIs antidepressants will be determined by the clinical specialist.
干预措施: sham acupuncture (Procedure)
结局指标
主要结局
Change in the Hamilton Depression Scale-17 (HAMD-17)
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
- Change in the MOS item short from health survey (SF-36)(Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.)
- Change in the Pittsburgh Sleep Quality Index (PSQI)(Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.)
- Change in the Treatment Emergent SymptomScale (TESS)(Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.)
研究者
Xiaomei Shao
Prof
The Third Affiliated hospital of Zhejiang Chinese Medical University