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
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jianhua Chen Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Zhenxiang Han Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Zouqing Huang Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.