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NCT Number: NCT07611487

Multimodal MRI Study of Acupuncture's Rapid Antidepressant Mechanisms and 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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Montgomery-Åsberg Depression Rating Scale Score

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

    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.

Secondary outcomes

  1. Hamilton Depression Rating Scale

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

    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.

  2. Positive and Negative Affect Schedule

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

    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).

  3. Maudsley Three-Item Visual Analogue Scale

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chunling Fan, M.D.

CONTACT

[email protected]

+86 10 89926000

YU MA, M.D.

CONTACT

[email protected]

+86 10 89926000

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Tsinghua University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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