Acupuncture and Escitalopram for Treating Major Depression Clinical Study

NCT05901571 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai 7th People's Hospital

Phase

Not applicable

Started

2026-11

Last updated

2026-03-11

Condition(s) studied

Depressive Disorder, Major

Investigational drug(s) / intervention(s)

acupunctureescitalopramsham-acupuncureescitalopram placebo

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.

escitalopram: Patients will receive 10 mg/day of escitalopram for the first 3 weeks and 20mg/day for the remaining 7 weeks.

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.

escitalopram placebo: Patients will receive 10 mg/day of escitalopram placebo for the first 3 weeks and 20mg/day for the remaining 7 weeks.

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Between 18 and 75 years of age with no gender-based restriction. 2. Fulfilling the diagnostic criteria of DSM-5 for major depressive disorder. 3. A Hamilton Rating Scale for Depression (HDRS-17) score ≥ 17 4. Ability to read and understand Mandarin Chinese, at least nine years of education, and willingness to adhere to the study protocol. 5. The absence of acupuncture treatment within at least 1 year. 6. Willingness to participate in the trial and provide written informed consent for the clinical trial. Exclusion Criteria: 1. Lifetime or current neuropsychiatric conditions, such as bipolar disorder, schizophrenia, substance dependence or abuse, dementia, brain injury, epilepsy and so forth. 2. High suicide risk or presenting with suicidal ideation (a score of more than 2 points on the Suicide question of the HDRS-17) at the time of entry. 3. Medicated with antidepressant at the start of the trial or history of treatment failure to escitalopram. 4. Pregnancy or breastfeeding. 5. Subjects who have acute inflammation at the planned acupuncture site on the body or any other contraindication to acupuncture. 6. Candidates afraid of needles in general and reluctant to receive acupuncture in particular 7. Known or suspected clinically unstable systemic medical disorder (including cancer, organ failure, or severe diseases of the cardiovascular, severe hepatic or renal insufficiency). 8. Previous participation in other acupuncture trials.

Primary outcome measure(s)

HDRS-17 scale — from baseline to 10 weeks
the change in the HDRS-17 score

Trial sites (3)

Facility	City	Region
Jianhua Chen	Shanghai	Shanghai Municipality
Zhenxiang Han	Shanghai	Shanghai Municipality
Zouqing Huang	Shanghai	Shanghai Municipality

On this site

📄 Lexapro (escitalopram) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05901571 on ClinicalTrials.gov ↗ ← All trials in China