NCT05901571

Acupuncture and Escitalopram for Treating Major Depression Clinical Study

Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS): Study Design of a Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Shanghai 7th People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

We will be able to investigate in a sample of patients free of antidepressants whether acupuncture is more effective than placebo.

Detailed description

This is a multicenter, randomized, controlled, 2 by 2 factorial clinical trial for Major depression.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
OTHER	acupuncture	The acupuncture group will receive treatment with needles inserted at the specified acupoints. Selected by acupuncture experts, these acupoints include DU20（Baihui) and SP4 (Gongsun) , PC6 (Neiguan) , PC5 (Jianshi) and LV 3 (Taichong) bilaterally. All acupoints are localized according to the WHO Standard Acupuncture Locations.After needle insertion, the acupuncture needles will be manipulated using either the twirling-rotating or lifting-thrusting methods to achieve the "De Qi" sensation.
OTHER	escitalopram	Patients will receive 10 mg/day of escitalopram for the first 3 weeks and 20mg/day for the remaining 7 weeks.
OTHER	sham-acupuncure	In the sham acupuncture group, superficial skin penetration (2 mm in depth) at nonacupoints will be done without De Qi manipulations. Nonacupoints are away from conventional acupoints or meridians. The choice of sham acupuncture points, which are points located in an emplacement different than the meridian points. The sham acupoints are not standard acupoints and will be about 1cun ( ≈20 mm) lateral from the real acupoints in the experimental group.
OTHER	escitalopram placebo	Patients will receive 10 mg/day of escitalopram placebo for the first 3 weeks and 20mg/day for the remaining 7 weeks.

Timeline

• Start date: 2026-11-01
• Primary completion: 2029-09-01
• Completion: 2030-02-01
• First posted: 2023-06-13
• Last updated: 2026-03-11

Locations

3 sites across 1 country: China