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NCT05901571Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 11 Mar 2026

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
216 (estimated)
First submitted
5 Jun 2023
Start date
1 Nov 2026
Primary completion date
30 Sept 2029
Lead sponsor
Shanghai 7th People's Hospital
Diseases
Depression
NCT number
NCT05901571

What you commit to

  • Study type: Interventional
  • Planned participants: 216
  • From 1 Nov 2026 to the primary completion date, 30 Sept 2029
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous participation in other acupuncture trials.

Other illness

  • Lifetime or current neuropsychiatric conditions, such as bipolar disorder, schizophrenia, substance dependence or abuse, dementia, brain injury, epilepsy and so forth.
  • Medicated with antidepressant at the start of the trial or history of treatment failure to escitalopram.
  • Known or suspected clinically unstable systemic medical disorder (including cancer, organ failure, or severe diseases of the cardiovascular, severe hepatic or renal insufficiency).

Other

  • 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.
  • Pregnancy or breastfeeding.
  • Subjects who have acute inflammation at the planned acupuncture site on the body or any other contraindication to acupuncture.
  • Candidates afraid of needles in general and reluctant to receive acupuncture in particular

Who the study is looking for

  • Between 18 and 75 years of age with no gender-based restriction.
  • Fulfilling the diagnostic criteria of DSM-5 for major depressive disorder.
  • A Hamilton Rating Scale for Depression (HDRS-17) score ≥ 17
  • Ability to read and understand Mandarin Chinese, at least nine years of education, and willingness to adhere to the study protocol.
  • The absence of acupuncture treatment within at least 1 year.
  • Willingness to participate in the trial and provide written informed consent for the clinical trial.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Jianhua Chen
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Zhenxiang Han
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Zouqing Huang
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.