Intradermal Needle Therapy for Major Depressive Disorder

Summary

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.

Conditions

• Major Depressive Disorder

Interventions

DRUG

SSRIs

SSRIs antidepressants will be used and the oral dose will be determined by the clinical specialist. Once-daily for 6 weeks.

PROCEDURE

acupuncture

This study will use the intradermal needle as an acupuncture intervention. Acupoints related to MDD will be stimulated. According to the position of the acupoints, choose a needle of φ0.20\*1.5m or φ0.20\*1.2mm. Press the needle to insert the acupoint vertically and retain it in the skin. After the intervention, the needle will be retained for 72 hours with a day of rest after removal. During needle retention, participants will be instructed to press the acupoints 3-4 times a day for about 1 minute each time, with the amount of stimulation as much as the patient can tolerate, at an interval of about 4 hours. A total of 10 treatment sessions will be performed for 6 weeks.

PROCEDURE

sham acupuncture

Sham acupuncture will use the same size, color, and material as the verum intradermal needle with a thin silicone pad in the middle instead of the needle body. The sham acupuncture will be needled on the points 1cm lateral to MDD-related acupoints. After the intervention, the needle will be retained for 72 hours with a day of rest after removal. A total of 10 sessions will be performed for 6 weeks.

DRUG

placebo

Oral placebo mimicking SSRIs antidepressants. Once-daily for 6 weeks.

Sponsors & Collaborators

• The Zhejiang Provincial Tongde Hospital

  collaborator UNKNOWN

• The Affiliated Hangzhou First People's Hospital

  collaborator UNKNOWN

• The Third Affiliated hospital of Zhejiang Chinese Medical University

  lead OTHER

Principal Investigators

• Xiaomei M Shao, Ph.D · The Third Affiliated hospital of Zhejiang Chinese Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-01

Primary Completion

2025-05-01

Completion

2025-12-30

Countries

• China

Study Locations