Depressive Disorder, MajorAE-TMDCSNCT05901571
Acupuncture and Escitalopram for Treating Major Depression Clinical Study
A study testing acupuncture and escitalopram in people with Depressive Disorder, Major, run by Shanghai 7th People's Hospital at 3 sites in China.
Trial summary
We will be able to investigate in a sample of patients free of antidepressants whether acupuncture is more effective than placebo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- acupuncture and escitalopram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 3 sitesChina
- Study dates
- Nov 2026to Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Jianhua Chen
Shanghai, Shanghai Municipality, 200030
Jianhua Chen, Dr, +86 216487250
Zhenxiang Han
Shanghai, Shanghai Municipality, 200137
Zhenxiang Han, 8572779808, hanxiang798007@163.com
Zouqing Huang
Shanghai, Shanghai Municipality
Zouqing Huang, Dr, +86 21 58909293
About this study
Official title: 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.
Read the detailed description
This is a multicenter, randomized, controlled, 2 by 2 factorial clinical trial for Major depression.
- Conditions
- Depressive Disorder, Major
- Being tested
- acupuncture, escitalopram, sham-acupuncure, escitalopram placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
Also called active 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.
escitalopramOther
Patients will receive 10 mg/day of escitalopram for the first 3 weeks and 20mg/day for the remaining 7 weeks.
sham-acupuncureOther
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 placeboOther
Patients will receive 10 mg/day of escitalopram placebo for the first 3 weeks and 20mg/day for the remaining 7 weeks.
| Study group | Role | What they receive |
|---|---|---|
| sham-acupuncture/placebo-pill | Sham comparator | sham-acupuncture protocol plus escitalopram placebo Receives: Other: sham-acupuncure; Other: escitalopram placebo |
| sham-acupuncture/escitalopram | Active comparator | sham-acupuncture protocol plus escitalopram Receives: Other: escitalopram; Other: sham-acupuncure |
| active acupuncture/placebo-pill | Active comparator | acupuncture protocol plus escitalopram placebo Receives: Other: acupuncture; Other: escitalopram placebo |
| active acupuncture/escitalopram | Experimental | acupuncture protocol plus escitalopram Receives: Other: acupuncture; Other: escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDRS-17 scale
the change in the HDRS-17 score
Measured: from baseline to 10 weeks
Secondary outcomes (4)
Beck depression inventory scale
the change in the Beck depression inventory score
Measured: from baseline to 10 weeks
The CGI(Clinical Global Impression) scale
the change in the CGI
Measured: from baseline to 10 weeks
The GAD-7(General Anxiety Disorder) scale
the change in the GAD-7
Measured: from baseline to 10 weeks
The Mini-Mental State Examination (MMSE) scale
the change in the MMSE
Measured: from baseline to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study startNov 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 7th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenxiang Han, Dr, Principal investigator, Shanghai Seventh People's Hospital, Shanghai University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901571
- Sponsor's protocol ID
- PWRl2021-05
- Other IDs
- 21Y11921000, 21ZR1449300
- Acronym
- AE-TMDCS
- Status last verified
- Mar 2026
- First submitted
- 5 Jun 2023
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The paper will be published. Anonymized demographic and clinical data as well as anonymized curated (i.e., after preprocessing and quality control) cytokine levels.
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.
PubMed 39260834
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS): Study Design of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05901571
- Acronym / sponsor ID
- AE-TMDCS / PWRl2021-05
- Conditions
- Depressive Disorder, Major
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Shanghai 7th People's HospitalUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will be able to investigate in a sample of patients free of antidepressants whether acupuncture is more effective than placebo.
Detailed description
This is a multicenter, randomized, controlled, 2 by 2 factorial clinical trial for Major depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| sham-acupuncture/placebo-pill | Sham comparator | Other: sham-acupuncure, Other: escitalopram placebosham-acupuncture protocol plus escitalopram placebo |
| sham-acupuncture/escitalopram | Active comparator | Other: escitalopram, Other: sham-acupuncuresham-acupuncture protocol plus escitalopram |
| active acupuncture/placebo-pill | Active comparator | Other: acupuncture, Other: escitalopram placeboacupuncture protocol plus escitalopram placebo |
| active acupuncture/escitalopram | Experimental | Other: acupuncture, Other: escitalopramacupuncture protocol plus escitalopram |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureAlso: active acupunctureThe 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 | active acupuncture/escitalopram, active acupuncture/placebo-pill |
| escitalopramPatients will receive 10 mg/day of escitalopram for the first 3 weeks and 20mg/day for the remaining 7 weeks. | Other | active acupuncture/escitalopram, sham-acupuncture/escitalopram |
| sham-acupuncureIn 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. | Other | sham-acupuncture/escitalopram, sham-acupuncture/placebo-pill |
| escitalopram placeboPatients will receive 10 mg/day of escitalopram placebo for the first 3 weeks and 20mg/day for the remaining 7 weeks. | Other | active acupuncture/placebo-pill, sham-acupuncture/placebo-pill |
Primary outcome
HDRS-17 scale
Time frame: from baseline to 10 weeks
the change in the HDRS-17 score
4 secondary outcomes
Beck depression inventory scale
Time frame: from baseline to 10 weeks
The CGI(Clinical Global Impression) scale
Time frame: from baseline to 10 weeks
The GAD-7(General Anxiety Disorder) scale
Time frame: from baseline to 10 weeks
The Mini-Mental State Examination (MMSE) scale
Time frame: from baseline to 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Derived from this study: PubMed 39260834Yang 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.
- Individual participant dataSharing planned: Yes. The paper will be published. Anonymized demographic and clinical data as well as anonymized curated (i.e., after preprocessing and quality control) cytokine levels.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhenxiang Han, Dr principal investigator
Shanghai Seventh People's Hospital, Shanghai University of TCM
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and escitalopram in people with Depressive Disorder, Major, run by Shanghai 7th People's Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenxiang Han, Dr. (+8617701767768, hanxiang798007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HDRS-17 scale (time frame: from baseline to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05901571, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.