Moderate Depressive Disorder With Cheek Acupuncture

NCT05923021 | Unknown DMC

• 1 other identifier: 2023-KLS-049-01
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acupuncture; Depression

Keywords

cheek acupuncture; depression; MDD; RCT research; functional links

Outcome Measures

Primary Outcomes (1)

• Change HAMD-17 score is being assessed at different time points

  The most commonly used scale for clinical assessment with depression. A score more than or equal to 24 indicates severe depression, a score more than or equal to 17 and less than 24 indicates moderate depression, and a score less than 7 indicates no depression.

  Baseline, 1week, 2 weeks, 3weeks, 4weeks, 8weeks, 12 weeks,20 weeks

Secondary Outcomes (2)

• Change PSQI score is being assessed at different time points

  Baseline, 1week, 2 weeks, 3weeks, 4weeks, 8weeks, 12 weeks,20 weeks

• Change HAMA score is being assessed at different time points

  Baseline, 1week, 2 weeks, 3weeks, 4weeks, 8weeks, 12 weeks,20 weeks

Study Arms (3)

Cheek acupuncture treatment group

EXPERIMENTAL

Needle selection: Select disposable trocars（φ0.18 × 25mm） (Wujiang Jiachen acupuncture and moxibustion Instrument Co., Ltd.) . Acupoints selection: bilateral Sanjiao points, bilateral head points, bilateral neck points, Needling depth: about 5mm-7.5mm, Needle retaining time: 30 minutes, course of treatment: 3 times a week, with a total of 36 cheek acupuncture treatments for 12 weeks.

Other: cheek acupuncture

Sham cheek acupuncture treatment group

SHAM COMPARATOR

Needle selection: Select disposable flat head trocars（φ0.18 × 25mm） (Wujiang Jiachen acupuncture and moxibustion Instrument Co., Ltd.) . Acupoints selection: Translate the bilateral Sanjiao points forward by 1cm（towards the front midline of the body）, translate the bilateral head points forward by 1cm, bilateral back points, Needling depth: Retained on the surface of the skin with the help of a cannula， Needle retaining time: 30 minutes, course of treatment: 3 times a week, with a total of 36 times of cheek acupuncture treatments for 12 weeks.

Other: cheek acupuncture

Drug group

ACTIVE COMPARATOR

Drug name: Sertraline Hydrochloride Tablets (trade name: Levofloxacin Sertraline, produced by Pfizer Pharmaceutical Co., Ltd., batch number: H10980141), Dosage form: tablets Usage: Take orally. 50 mg/d, taken after breakfast. Depending on the patient's condition, the dosage can be increased to 200mg/d, taken after breakfast, or divided twice a day after meals Treatment cycle: a total of 12 weeks.

Other: cheek acupuncture

Interventions

cheek acupuncture OTHER

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.In this study, we use the big three jiao points, head points, and neck points in cheek acupuncture therapy to treat depression. These acupoints are considered effective in long-term clinical applications.

Also known as: Sertraline Hydrochloride Tablets

Cheek acupuncture treatment group; Drug group; Sham cheek acupuncture treatment group

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead

MeSH Terms

Conditions

Depression

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The project adopts a central random system for random grouping and obtains a random number. The random number does not reflect grouping information, so blind method can be implemented for subjects and evaluators. However, due to the setting of sham cheek acupuncture in the project grouping, blind method can't be implemented for researchers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 28, 2023
• Study Start: July 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share