Acupuncture and Escitalopram for Treating Major Depression Clinical Study
AE-TMDCS
3 other identifiers
interventional
216
1 country
3
Brief Summary
We will be able to investigate in a sample of patients free of antidepressants whether acupuncture is more effective than placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2026
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2023
CompletedFirst Posted
Study publicly available on registry
June 13, 2023
CompletedStudy Start
First participant enrolled
November 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2029
Study Completion
Last participant's last visit for all outcomes
February 1, 2030
March 11, 2026
March 1, 2026
2.8 years
June 5, 2023
March 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
HDRS-17 scale
the change in the HDRS-17 score
from baseline to 10 weeks
Secondary Outcomes (4)
Beck depression inventory scale
from baseline to 10 weeks
The CGI(Clinical Global Impression) scale
from baseline to 10 weeks
The GAD-7(General Anxiety Disorder) scale
from baseline to 10 weeks
The Mini-Mental State Examination (MMSE) scale
from baseline to 10 weeks
Other Outcomes (3)
BDNF
at baseline and 10 week
IL18/IL-1β
at baseline and 10 week
fMRI
at baseline and 10 week
Study Arms (4)
sham-acupuncture/placebo-pill
SHAM COMPARATORsham-acupuncture protocol plus escitalopram placebo
sham-acupuncture/escitalopram
ACTIVE COMPARATORsham-acupuncture protocol plus escitalopram
active acupuncture/placebo-pill
ACTIVE COMPARATORacupuncture protocol plus escitalopram placebo
active acupuncture/escitalopram
EXPERIMENTALacupuncture protocol plus escitalopram
Interventions
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.
Patients will receive 10 mg/day of escitalopram for the first 3 weeks and 20mg/day for the remaining 7 weeks.
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.
Patients will receive 10 mg/day of escitalopram placebo for the first 3 weeks and 20mg/day for the remaining 7 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Jianhua Chen
Shanghai, Shanghai Municipality, 200030, China
Zhenxiang Han
Shanghai, Shanghai Municipality, 200137, China
Zouqing Huang
Shanghai, Shanghai Municipality, China
Related Publications (1)
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.
PMID: 39260834DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhenxiang Han, Dr
Shanghai Seventh People's Hospital, Shanghai University of TCM
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2023
First Posted
June 13, 2023
Study Start (Estimated)
November 1, 2026
Primary Completion (Estimated)
September 1, 2029
Study Completion (Estimated)
February 1, 2030
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Access Criteria
- ResMan IPD
The paper will be published. Anonymized demographic and clinical data as well as anonymized curated (i.e., after preprocessing and quality control) cytokine levels.