Multimodal MRI Study of Acupuncture's Rapid Antidepressant Mechanisms and Response Prediction in Depression

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Procedure: Acupuncture; Procedure: Sham Acupuncture

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chunling Fan, M.D.; Phone Number: +86 10 89926000; Email: fanjingzi1@126.com
• Study Contact Backup: Name: YU MA, M.D.; Phone Number: +86 10 89926000; Email: mayu@tsinghua.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Aged 18 to 59 years, and right-handed;
2. 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;
3. Having a total score on the 17-item Hamilton Depression Rating Scale (HAMD-17) greater than 7 and less than or equal to 24;
4. Voluntary participation in the study, with written informed consent provided by the patient themselves or their legally authorized guardian.

Exclusion Criteria:

1. Diagnosis of other major psychiatric disorders or presence of psychotic symptoms.
2. History of other severe somatic diseases (e.g., cardiovascular/cerebrovascular diseases, autoimmune diseases), or current/past neurological or organic brain diseases.
3. Current or past history of alcohol dependence or abuse of other psychoactive substances.
4. Women who are lactating, pregnant, or menstruating.
5. Patients who have participated in other clinical drug trials within the past 3 months.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture group; Participants in the acupuncture group will receive real acupuncture treatment. Acupoints will be selected according to the Chinese national standard "Nomenclature and Location of Meridian Points" (GB/T 12346-2006), including Baihui (GV20), Sishencong (EX-HN1), Shenting (GV24), Touwei (ST8), Fengchi (GB20), Anmian (EX-HN22), Neiguan (PC6), Shenmen (HT7), and Sanyinjiao (SP6). Electrical stimulation will be applied using sparse-dense waves at frequencies of 2 Hz and 100 Hz, with an intensity ranging from 0.1 to 1 mA. Treatment will be performed by licensed acupuncturists following a standardized operation manual. Each acupuncture session lasts 30 minutes, and participants will receive one session of acupuncture treatment. Participants will remain blinded to group allocation.	Procedure: Acupuncture; 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 Comparator: Sham Acupuncture Group; Participants in the sham acupuncture group will receive sham acupuncture using non-insertive placebo needles. The same acupoints and treatment protocol will be applied as in the acupuncture group (sham acupuncture session lasting 30 minutes, single session). The procedure mimics real acupuncture without skin penetration or active stimulation, and appears visually indistinguishable from real acupuncture. The electroacupuncture device will not deliver electrical output. Participants will remain blinded to group allocation.	Procedure: Sham Acupuncture; Participants will receive sham acupuncture as a control intervention using non-therapeutic acupuncture procedures designed to mimic acupuncture without providing active therapeutic effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Depression Rating Scale	Change in short-term depressive symptom severity measured by the 17-item Hamilton Depression Rating Scale (HAMD-17). The total score ranges from 0 to 52, with higher scores indicating more severe depression.	Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture
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).	Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture
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.	Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Tsinghua University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 10, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Therapeutics; Complementary Therapies; Acupuncture Therapy
• Other Study ID Numbers: 2026LH001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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