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ClinicalTrials.gov ID

NCT05901571

Lead Sponsor

Shanghai 7th People's HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

216Estimated

Last Update Posted

Mar 11, 2026Actual

Start Date

Nov 2026Estimated

Primary Completion Date

Sep 2029Estimated

Completion Date

Feb 2030Estimated

Official Title

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

Brief 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.

• Depressive Disorder, Major

• acupuncture
• escitalopram
• sham-acupuncure
• escitalopram placebo

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Shanghai 7th People's HospitalOTHER

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