Efficacy and Safety of Intradermal Acupuncture for Major Depressive Disorder: a Study Protocol for a Multicenter, Prospective, Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Major depressive disorder (MDD) is a common mental illness that severely affects the health and quality of life of patients. Treatment with acupuncture alone or a combination of appropriate adjuncts has been reported to be significantly effective in reducing the severity of MDD, relieving patients' somatic symptoms and improving sleep. This study will focus on the intradermal acupuncture, which is more convenient, gentler and has longer lasting effects. The aim is to study the efficacy and safety of intradermal acupuncture for MDD, and to preliminarily explore the central nervous mechanisms by which it exerts its therapeutic effects.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• Patients diagnosed with MDD according to the International Classification of Disease-10 (ICD-10);
• Aged between 18 and 60 years (no limitation on gender);
• No depression-related treatment in the past two weeks, except 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.
Locations
Other Locations
China
the Third affiliated hospital of Zhejiang Chinese Medical university
RECRUITING
Hangzhou
Contact Information
Primary
Xiaomei Shao, Ph.D
shaoxiaomei@zcmu.edu.cn
+8618957130287
Backup
Xiaoting Wu
xiaotwu@163.com
+8618196671636
Time Frame
Start Date:2022-01-01
Estimated Completion Date:2025-12-30
Participants
Target number of participants:90
Treatments
Active_comparator: Waiting list group
This group will include 30 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.
Sham_comparator: SIA+SSRIs group
This group will include 30 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.
Experimental: AIA+SSRIs group
This group will include 30 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.
Collaborators: The First Affiliated Hospital of Zhejiang Chinese Medical University, First People's Hospital of Hangzhou, Zhejiang Provincial Tongde Hospital