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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Acupuncture
Procedure/SurgeryParticipants 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/SurgeryParticipants will receive sham acupuncture as a control intervention using non-therapeutic acupuncture procedures designed to mimic acupuncture without providing active therapeutic effects.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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).
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.
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.
Locations
Sponsors and contacts
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