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

NCT07611487 | Not Yet Recruiting

• 1 other identifier: 2026LH001
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hamilton Depression Rating Scale

  Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture

• Positive and Negative Affect Schedule

  Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture

• Maudsley Three-Item Visual Analogue Scale

  Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture

Study Arms (2)

Acupuncture group

EXPERIMENTAL

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

Sham Acupuncture Group

SHAM COMPARATOR

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

Interventions

Acupuncture PROCEDURE

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.

Acupuncture group

Sham Acupuncture PROCEDURE

Participants will receive sham acupuncture as a control intervention using non-therapeutic acupuncture procedures designed to mimic acupuncture without providing active therapeutic effects.

Sham Acupuncture Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Tsinghua University: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Chunling Fan, M.D.

CONTACT

+86 10 89926000; fanjingzi1@126.com

YU MA, M.D.

CONTACT

+86 10 89926000; mayu@tsinghua.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share