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NCT Number: NCT05901571

Acupuncture and Escitalopram for Treating Major Depression Clinical Study

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jianhua Chen, Shanghai, Shanghai Municipality, China

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Acupuncture

Other

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 names: active acupuncture

escitalopram

Other

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

sham-acupuncure

Other

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

Other

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

Primary outcomes

  1. HDRS-17 scale

    Time frame: from baseline to 10 weeks

    the change in the HDRS-17 score

Secondary outcomes

  1. Beck depression inventory scale

    Time frame: from baseline to 10 weeks

    the change in the Beck depression inventory score

  2. The CGI(Clinical Global Impression) scale

    Time frame: from baseline to 10 weeks

    the change in the CGI

  3. The GAD-7(General Anxiety Disorder) scale

    Time frame: from baseline to 10 weeks

    the change in the GAD-7

  4. The Mini-Mental State Examination (MMSE) scale

    Time frame: from baseline to 10 weeks

    the change in the MMSE

Other outcomes

  1. BDNF

    Time frame: at baseline and 10 week

    serum BDNF level

  2. IL18/IL-1β

    Time frame: at baseline and 10 week

    serum IL18/IL-1β level

  3. fMRI

    Time frame: at baseline and 10 week

    functional MRI

Study contacts

Contact information is provided by the study sponsor or research team.

Zhenxiang Han, Dr.

CONTACT

[email protected]

+8617701767768

Sponsors and collaborators

Lead sponsor

Shanghai 7th People's Hospital

Other

Registry information

Official study title

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

Acronym: AE-TMDCS

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jun 13, 2023
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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