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Not yet recruiting NCT07611487

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

No phase Interventional Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acupuncture, Sham Acupuncture.
Who it may be relevant to
Registry conditions: Major Depressive Disorder. Basic parameters: 18 years — 59 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multimodal MRI-Based Study on the Rapid Antidepressant Mechanisms of Acupuncture and Individualized Treatment Response Prediction in Depression

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Montgomery-Åsberg Depression Rating Scale Score [Time frame: Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture]
Secondary outcome measures (3)
  • Hamilton Depression Rating Scale [Time frame: Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture]
  • Positive and Negative Affect Schedule [Time frame: Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture]
  • Maudsley Three-Item Visual Analogue Scale [Time frame: Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07611487 · 2026LH001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗