Clinical trial NCT05923021: Moderate Depressive Disorder With Cheek Acupuncture
Official title: A Randomized Controlled Study on the Treatment of Moderate Depressive Disorder With Cheek Acupuncture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acupuncture
Depression
Keywords: cheek acupuncture
depression
MDD
RCT research
functional links
Lead sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 126
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The specific method is to randomly assign 126 patients with moderate depressive disorder to cheek acupuncture group, sham cheek acupuncture group and drug group, evaluate the treatment effect with HAMD-17, PSQI and HAMA, observe the improvement of cheek acupuncture on depression, anxiety and sleep of patients with moderate depressive disorder, and observe the changes of functional links in various brain regions of patients in each group before and after treatment through resting state functional magnetic resonance imaging technology.
Primary purpose: TREATMENT

Brief summary: This study intends to use a randomized controlled clinical study to clarify the clinical efficacy of cheek acupuncture therapy in patients with moderate depressive disorder. And also to find the antidepressant mechanism of cheek acupuncture therapy on moderate depressive disorder by using resting state functional magnetic resonance imaging. The specific method is to randomly assign 126 patients with moderate depressive disorder to cheek acupuncture group, sham cheek acupuncture group and drug group, evaluate the treatment effect with HAMD-17, PSQI and HAMA, observe the improvement of cheek acupuncture on depression, anxiety and sleep quality of patients with moderate depressive disorder, and observe the changes of functional links in various brain regions of patients in each group before and after treatment through resting state functional magnetic resonance imaging technology.

Detailed description: Cheek acupuncture therapy refers to a new painless acupuncture therapy for treating systemic diseases by acupuncture at specific points on the cheek. This therapy was founded by Professor Wang Yongzhou, a scholar in France. Cheek acupuncture therapy takes the Yellow Emperor's Internal Classic as the theoretical basis, and organically integrates holographic theory, the theory of ascending and descending qi, the theory of Big Three Jiao, the theory of simultaneous treatment of mind and body, and the theory of the book of Changes. After long-term and extensive clinical practice and continuous experience summary, a relatively independent and complete treatment system has been formed. Since its initial discovery in 1991, cheek acupuncture has undergone clinical observation and verification by numerous doctors for nearly 100000 times. Its therapeutic effect is stable and reliable, and it has a strong therapeutic advantage for psychosomatic diseases represented by depression. The members of the research group have been learning about cheek acupuncture since 2017 and have applied it to the treatment of patients with depression, achieving satisfactory clinical efficacy.

Major depressive disorder (MDD) is a type of disorder with high incidence, recurrence, disability, and the risk of suicide for severe mental disorders with a high suicide rate is about 20 times higher than that of the general population. The main clinical features of this disease are low mood, decreased interest, and lacking in strength. Many patients also experience symptoms such as cognitive decline, autonomic dysfunction, sleep disorders, and altered appetite. A 2013 study on the global burden of disease pointed out that depression is the second largest burden disease worldwide, with a prevalence rate of 6.7% in China About 9%, with a total number of approximately 95 million cases. Deeply exploring the pathogenesis of depression and exploring new antidepressant therapies have significant practical significance.

In this situation, the investigators design a randomized controlled clinical study, firstly to clarify the cure effect of cheek acupuncture therapy, secondly to find the central mechanism of it on antidepressant effect.The specific method is to randomly assign 126 patients with moderate depressive disorder to cheek acupuncture group, sham cheek acupuncture group and drug group, evaluate the treatment effect with HAMD-17, PSQI and HAMA, observe the improvement of cheek acupuncture on depression, anxiety and sleep of patients with moderate depressive disorder, and observe the changes of functional links in various brain regions of patients in each group before and after treatment through resting state functional magnetic resonance imaging technology.

Eligibility criteria: Inclusion Criteria:

* ① Conforming to the diagnostic standards of traditional Chinese and Western medicine;

  * Age range from 10 to 65 years old;

    * HAMD-17 scores\>14 ;

      * Sign an informed consent form (Minors need to obtain recognition from their guardians and have their informed consent signed by their guardians) and voluntarily participate in this study.

Only those who meet the above 4 criteria can be included in the study.

Exclusion Criteria:

* ①Individuals with significant suicidal tendencies;

  * Previously diagnosed with intellectual disabilities, schizophrenia, bipolar disorder, substance abuse (such as alcohol dependence), or other mental disorders;

    * Epilepsy history or strong positive epilepsy family history, brain organic disease and serious physical disease history;

      * Individuals who are taking antidepressants within 6 weeks (including 6 weeks);

        * Pregnancy, preparation or lactation period;

          * Patients with skin lesions or skin diseases, severe diabetes, tumors and dysfunction of important organs, or severe internal diseases such as liver, kidney, cardiovascular, endocrine, respiratory and hematopoietic systems;

            ⑦ Contraindications for fMRI examination, such as pacemakers, cardiac stents, and claustrophobia;
            * Patients with other central or peripheral neuropathy.

Those who meet any of the above criteria will be excluded from the study

Primary outcomes:
measure: Change HAMD-17 score is being assessed at different time points
timeFrame: Baseline, 1week, 2 weeks, 3weeks, 4weeks, 8weeks, 12 weeks,20 weeks
Secondary outcomes:
measure: Change PSQI score is being assessed at different time points
timeFrame: Baseline, 1week, 2 weeks, 3weeks, 4weeks, 8weeks, 12 weeks,20 weeks
measure: Change HAMA score is being assessed at different time points
timeFrame: Baseline, 1week, 2 weeks, 3weeks, 4weeks, 8weeks, 12 weeks,20 weeks
Other outcomes:
Locations:
Study officials:
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