Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Other: escitalopram placebo; Other: escitalopram; Other: sham-acupuncure; Other: acupuncture

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhenxiang Han, Dr.; Phone Number: +8617701767768; Email: hanxiang798007@163.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Jianhua Chen
      • Contact: Jianhua Chen, Dr; Phone Number: +86 216487250
    • Shanghai, Shanghai Municipality, China, 200137
      • Zhenxiang Han
      • Contact: Zhenxiang Han; Phone Number: 8572779808; Email: hanxiang798007@163.com
    • Shanghai, Shanghai Municipality, China
      • Zouqing Huang
      • Contact: Zouqing Huang, Dr; Phone Number: +86 21 58909293

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: sham-acupuncture/placebo-pill; sham-acupuncture protocol plus escitalopram placebo	Other: escitalopram placebo; Patients will receive 10 mg/day of escitalopram placebo for the first 3 weeks and 20mg/day for the remaining 7 weeks.; Other: 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.
Active Comparator: sham-acupuncture/escitalopram; sham-acupuncture protocol plus escitalopram	Other: escitalopram; Patients will receive 10 mg/day of escitalopram for the first 3 weeks and 20mg/day for the remaining 7 weeks.; Other: 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.
Active Comparator: active acupuncture/placebo-pill; acupuncture protocol plus escitalopram placebo	Other: escitalopram placebo; Patients will receive 10 mg/day of escitalopram placebo for the first 3 weeks and 20mg/day for the remaining 7 weeks.; Other: 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.; Other Names: active acupuncture
Experimental: active acupuncture/escitalopram; acupuncture protocol plus escitalopram	Other: escitalopram; Patients will receive 10 mg/day of escitalopram for the first 3 weeks and 20mg/day for the remaining 7 weeks.; Other: 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.; Other Names: active acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HDRS-17 scale	the change in the HDRS-17 score	from baseline to 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck depression inventory scale	the change in the Beck depression inventory score	from baseline to 10 weeks
The CGI(Clinical Global Impression) scale	the change in the CGI	from baseline to 10 weeks
The GAD-7(General Anxiety Disorder) scale	the change in the GAD-7	from baseline to 10 weeks
The Mini-Mental State Examination (MMSE) scale	the change in the MMSE	from baseline to 10 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
BDNF	serum BDNF level	at baseline and 10 week
IL18/IL-1β	serum IL18/IL-1β level	at baseline and 10 week
fMRI	functional MRI	at baseline and 10 week

Collaborators and Investigators

• Sponsor: Shanghai 7th People's Hospital
• Investigators: Principal Investigator: Zhenxiang Han, Dr, Shanghai Seventh People's Hospital, Shanghai University of TCM

Publications and helpful links

General Publications

• Yang K, Tiwari S, Liu D, Xu Q, Qi L, Zhu Y, Jiang L, Zouqin H, Wong J, Chen J, Han Z. Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS): protocol for a factorial randomised controlled trial. BMJ Open. 2024 Sep 10;14(9):e091214. doi: 10.1136/bmjopen-2024-091214.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Complementary Therapies; Amines; Nitriles; Propylamines; Benzofurans; Escitalopram; Acupuncture Therapy
• Other Study ID Numbers: PWRl2021-05; 21Y11921000 (Other Grant/Funding Number: Shanghai science and techonology committe); 21ZR1449300 (Other Grant/Funding Number: Natural Science Foundation of Shanghai)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The paper will be published. Anonymized demographic and clinical data as well as anonymized curated (i.e., after preprocessing and quality control) cytokine levels.
• IPD Sharing Access Criteria: ResMan IPD
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No