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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-59
SponsorSecond Affiliated Hospital of Tsinghua University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acupuncture

    Procedure/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 Acupuncture

    Procedure/Surgery

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Acupuncture groupExperimental treatment 1 intervention
Group B: Sham Acupuncture GroupSham comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline (before acupuncture), 1 hour, 24 hours, and 72 hours after acupuncture treatment.

Secondary outcomes

1

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).

Time frame
Baseline (before acupuncture), 1 hour, 24 hours, and 72 hours after acupuncture treatment.
2

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.

Time frame
Baseline (before acupuncture), 1 hour, 24 hours, and 72 hours after acupuncture treatment.
3

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.

Time frame
Baseline (before acupuncture), 24 hours and 72 hours after acupuncture treatment.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: