Intradermal Needle Therapy for Major Depressive Disorder

NANot yet recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

May 1, 2022

Primary Completion Date

May 1, 2025

Study Completion Date

December 30, 2025

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.

Trial Locations (1)

Unknown

Xiaomei Medical Shao, Hangzhou

All Listed Sponsors
collaborator

The Zhejiang Provincial Tongde Hospital

UNKNOWN

collaborator

The Affiliated Hangzhou First People's Hospital

UNKNOWN

lead

The Third Affiliated hospital of Zhejiang Chinese Medical University

OTHER

NCT05352113 - Intradermal Needle Therapy for Major Depressive Disorder | Biotech Hunter | Biotech Hunter