Major Depressive DisorderNCT07611487
Multimodal MRI Study of Acupuncture's Rapid Antidepressant Mechanisms and Response Prediction in Depression
A study testing Acupuncture in people with Major Depressive Disorder, run by Second Affiliated Hospital of Tsinghua University.
Trial summary
This study aims to investigate the rapid antidepressant effects of acupuncture and to explore the underlying brain mechanisms using multimodal MRI techniques. In addition, the study will evaluate whether individual treatment responses can be predicted based on neuroimaging and clinical data. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2026to 31 Dec 2028
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 59 years, and right-handed;
- Patients who have received systematic antidepressant treatment (including antidepressant medications, sedative-hypnotics, electroconvulsive therapy, or transcranial magnetic stimulation) within the 4 weeks prior to enrollment;
- Having a total score on the 17-item Hamilton Depression Rating Scale (HAMD-17) greater than 7 and less than or equal to 24;
- Voluntary participation in the study, with written informed consent provided by the patient themselves or their legally authorized guardian.
Who cannot join
- Diagnosis of other major psychiatric disorders or presence of psychotic symptoms.
- History of other severe somatic diseases (e.g., cardiovascular/cerebrovascular diseases, autoimmune diseases), or current/past neurological or organic brain diseases.
- Current or past history of alcohol dependence or abuse of other psychoactive substances.
- Women who are lactating, pregnant, or menstruating.
- Patients who have participated in other clinical drug trials within the past 3 months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multimodal MRI-Based Study on the Rapid Antidepressant Mechanisms of Acupuncture and Individualized Treatment Response Prediction in Depression
This study aims to investigate the rapid antidepressant effects of acupuncture and to explore the underlying brain mechanisms using multimodal MRI techniques. In addition, the study will evaluate whether individual treatment responses can be predicted based on neuroimaging and clinical data.
Participants diagnosed with mild to moderate depression will be enrolled and will receive acupuncture treatment. Depression-related clinical assessment scales and brain imaging data will be collected before and after treatment.
The results of this study may help to better understand the mechanisms of acupuncture in rapid antidepressant treatment and support the development of personalized treatment strategies.
- Conditions
- Major Depressive Disorder
- Being tested
- Acupuncture, Sham Acupuncture
- 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.
AcupunctureProcedure or surgery
Participants will receive standardized acupuncture treatment for mild to moderate depression according to the study protocol. Acupuncture will be administered by qualified practitioners at predefined acupoints during the treatment period.
Sham AcupunctureProcedure or surgery
Participants will receive sham acupuncture as a control intervention using non-therapeutic acupuncture procedures designed to mimic acupuncture without providing active therapeutic effects.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Acupuncture prescription: Baihui (GV20), Shenting (GV24), Yintang (GV29), Anmian (EX-HN22, bilateral), Neiguan (PC6, bilateral), Shenmen (HT7, bilateral), Sanyinjiao (SP6, bilateral), and Taichong (LR3, bilateral). Acupoint locations will be determined according to GB/T 12346-2021 Nomenclature and Location of Meridian Points and GB/T 40997-2021 Nomenclature and Location of Extra Points. Electroacupuncture will be applied between Baihui (GV20) and Yintang (GV29) using a 2 Hz continuous wave, with the current intensity adjusted within 0.1-1.0 mA to a level that is tolerable and non-painful for the participant. Shenting (GV24), Anmian (EX-HN22), Neiguan (PC6), Shenmen (HT7), Sanyinjiao (SP6), and Taichong (LR3) will be retained without electrical stimulation. Receives: Procedure: Acupuncture |
| Sham Acupuncture Group | Sham comparator | The sham acupuncture group will receive a predefined set of non-meridian, non-acupoint locations matched in number to those used in the acupuncture group. Non-penetrating placebo needles will be used to simulate the appearance and procedure of needle insertion without penetrating the skin. Corresponding to the Baihui (GV20)-Yintang (GV29) electroacupuncture connection in the verum acupuncture group, two predefined non-meridian, non-acupoint locations on the head will be connected to the same electroacupuncture device and leads. Device settings and visual cues will be kept as similar as possible to those in the verum acupuncture group, but no electrical current will be delivered. Receives: Procedure: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg Depression Rating Scale Score
Change in short-term depressive symptom severity measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), a 10-item scale with a total score ranging from 0 to 60. Higher scores indicate worse depression outcomes.
Measured: Baseline (before acupuncture), 1 hour, 24 hours, and 72 hours after acupuncture treatment.
Secondary outcomes (3)
Positive and Negative Affect Schedule
Change in short-term positive and negative affect measured by the Positive and Negative Affect Schedule (PANAS). The PANAS consists of two 10-item subscales: Positive Affect (PA) and Negative Affect (NA), each with a total score ranging from 10 to 50. For the PA subscale, higher scores indicate better outcomes (greater positive affect). For the NA subscale, higher scores indicate worse outcomes (greater negative affect).
Measured: Baseline (before acupuncture), 1 hour, 24 hours, and 72 hours after acupuncture treatment.
Maudsley Three-Item Visual Analogue Scale
Change in short-term subjective mood state measured by the Maudsley Three-Item Visual Analogue Scale. The scale consists of three separate visual analogue items (e.g., happiness, anxiety, depression), each scored from 0 to 100 mm (0 = absence of the feeling, 100 = extreme feeling). For the happiness item, a higher score indicates a better outcome. For the anxiety and depression items, higher scores indicate worse outcomes.
Measured: Baseline (before acupuncture), 1 hour, 24 hours, and 72 hours after acupuncture treatment.
Snaith-Hamilton Pleasure Scale
Change in anhedonia measured by the Snaith-Hamilton Pleasure Scale (SHAPS). The scale consists of 14 items, with a total score ranging from 0 to 14 using the original scoring method. Higher scores indicate more severe anhedonia.
Measured: Baseline (before acupuncture), 24 hours and 72 hours after acupuncture treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start8 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Tsinghua University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fan Chunling,MD, Second Affiliated Hospital of Tsinghua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611487
- Sponsor's protocol ID
- 2026LH001
- Status last verified
- Sep 2026
- First submitted
- 10 May 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal MRI-Based Study on the Rapid Antidepressant Mechanisms of Acupuncture and Individualized Treatment Response Prediction in Depression
- ClinicalTrials.gov ID
- NCT07611487
- Acronym / sponsor ID
- 2026LH001
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Tsinghua UniversityUniversity, hospital or other
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 May 2026 (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.
This study aims to investigate the rapid antidepressant effects of acupuncture and to explore the underlying brain mechanisms using multimodal MRI techniques. In addition, the study will evaluate whether individual treatment responses can be predicted based on neuroimaging and clinical data.
Participants diagnosed with mild to moderate depression will be enrolled and will receive acupuncture treatment. Depression-related clinical assessment scales and brain imaging data will be collected before and after treatment.
The results of this study may help to better understand the mechanisms of acupuncture in rapid antidepressant treatment and support the development of personalized treatment strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Procedure: AcupunctureAcupuncture prescription: Baihui (GV20), Shenting (GV24), Yintang (GV29), Anmian (EX-HN22, bilateral), Neiguan (PC6, bilateral), Shenmen (HT7, bilateral), Sanyinjiao (SP6, bilateral), and Taichong (LR3, bilateral). Acupoint locations will be determined according to GB/T 12346-2021 Nomenclature and Location of Meridian Points and GB/T 40997-2021 Nomenclature and Location of Extra Points. Electroacupuncture will be applied between Baihui (GV20) and Yintang (GV29) using a 2 Hz continuous wave, with the current intensity adjusted within 0.1-1.0 mA to a level that is tolerable and non-painful for the participant. Shenting (GV24), Anmian (EX-HN22), Neiguan (PC6), Shenmen (HT7), Sanyinjiao (SP6), and Taichong (LR3) will be retained without electrical stimulation. |
| Sham Acupuncture Group | Sham comparator | Procedure: Sham AcupunctureThe sham acupuncture group will receive a predefined set of non-meridian, non-acupoint locations matched in number to those used in the acupuncture group. Non-penetrating placebo needles will be used to simulate the appearance and procedure of needle insertion without penetrating the skin. Corresponding to the Baihui (GV20)-Yintang (GV29) electroacupuncture connection in the verum acupuncture group, two predefined non-meridian, non-acupoint locations on the head will be connected to the same electroacupuncture device and leads. Device settings and visual cues will be kept as similar as possible to those in the verum acupuncture group, but no electrical current will be delivered. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18 to 59 years, and right-handed;
- Patients who have received systematic antidepressant treatment (including antidepressant medications, sedative-hypnotics, electroconvulsive therapy, or transcranial magnetic stimulation) within the 4 weeks prior to enrollment;
- Having a total score on the 17-item Hamilton Depression Rating Scale (HAMD-17) greater than 7 and less than or equal to 24;
- Voluntary participation in the study, with written informed consent provided by the patient themselves or their legally authorized guardian.
Key exclusion criteria (5 listed)
- Diagnosis of other major psychiatric disorders or presence of psychotic symptoms.
- History of other severe somatic diseases (e.g., cardiovascular/cerebrovascular diseases, autoimmune diseases), or current/past neurological or organic brain diseases.
- Current or past history of alcohol dependence or abuse of other psychoactive substances.
- Women who are lactating, pregnant, or menstruating.
- Patients who have participated in other clinical drug trials within the past 3 months.
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 |
|---|---|---|
| AcupunctureParticipants will receive standardized acupuncture treatment for mild to moderate depression according to the study protocol. Acupuncture will be administered by qualified practitioners at predefined acupoints during the treatment period. | Procedure or surgery | Acupuncture group |
| Sham AcupunctureParticipants will receive sham acupuncture as a control intervention using non-therapeutic acupuncture procedures designed to mimic acupuncture without providing active therapeutic effects. | Procedure or surgery | Sham Acupuncture Group |
Primary outcome
Montgomery-Åsberg Depression Rating Scale Score
Time frame: Baseline (before acupuncture), 1 hour, 24 hours, and 72 hours after acupuncture treatment.
Change in short-term depressive symptom severity measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), a 10-item scale with a total score ranging from 0 to 60. Higher scores indicate worse depression outcomes.
3 secondary outcomes
Positive and Negative Affect Schedule
Time frame: Baseline (before acupuncture), 1 hour, 24 hours, and 72 hours after acupuncture treatment.
Maudsley Three-Item Visual Analogue Scale
Time frame: Baseline (before acupuncture), 1 hour, 24 hours, and 72 hours after acupuncture treatment.
Snaith-Hamilton Pleasure Scale
Time frame: Baseline (before acupuncture), 24 hours and 72 hours after acupuncture treatment.
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 7 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Major Depressive Disorder, run by Second Affiliated Hospital of Tsinghua University.
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 4 inclusion and 5 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 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Chunling Fan, M.D. (+86 10 89926000, fanjingzi1@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Åsberg Depression Rating Scale Score (time frame: Baseline (before acupuncture), 1 hour, 24 hours, and 72 hours after acupuncture treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.