The Biological Specificity of Acupoints Between Major Depressive Disorder Patients and Healthy Controls

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT06114342
• Lead Sponsor: Xiaomei Shao

Brief Summary

Evidence-based medicine suggests that acupuncture can improve major depressive disorder (MDD). However, the prevalent reliance on experiential acupoint selection lacks scientific underpinning. The investigators conducted a comparative study involving MDD patients and healthy subjects, employing modern techniques to discern biological specificity in MDD-related acupoints. Additionally, the investigators investigated potential correlations between acupoint biological specificity and MDD severity.

Detailed Description

A final total of 134 eligible subjects were included. Among them, 50 healthy subjects were assigned to the healthy control (HC) group and 84 MDD participants were assigned to the MDD group.

Study Timeline

• Study Start: 2022-01-10
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Study First Submitted: 2023-10-28
• Study First Submitted QC: 2023-10-28
• Study First Posted: 2023-11-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

Inclusion criteria for the healthy control participants:

• provided a recent depression screening report, and be free of any cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological disease;
• 18 ≤ age ≤60 years, male or female;
• had clear consciousness and could communicate with others normally; - understand the full study protocol and have high adherence;
• signed the written informed consent.

Inclusion criteria for the MDD participants:

• consistent with the diagnosis of MDD in the International Classification of Diseases 10th Edition (ICD-10);
• 18 ≤ age ≤ 60, male or female;
• had clear consciousness and could communicate with others normally;
• understand the full study protocol and have high adherence;
• signed the written informed consent.

Exclusion Criteria

• The exclusion criteria of the HC participants were as follows: (1) had serious primary diseases of cardiovascular diseases, liver diseases, kidney diseases, urinary diseases, and hematological diseases; (2) pregnant or lactating; (3) had scars, hyperpigmentation, red and swollen of the skin at the test site; (4) were participating in other trials; (5) had a mental illness, alcohol dependence, or a history of drug abuse. Exclusion criteria for the MDD participants: (1)-(4) same exclusion criteria as healthy subjects; (5) MDD caused by organic mental disorders, schizophrenia, bipolar disorder, psychoactive substances, and non-addictive substances; (6) had psychiatric disorders other than MDD; (7) with suicidal tendencies. In addition, IRT is not be performed on female subjects during their menstrual and ovulatory periods.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Temperature	Baseline	Temperature of acupoints was measured by infrared thermography (IRT). IRT was not be performed on female subjects during their menstrual and ovulatory periods.
Pressure pain threshold	Baseline	Pressure pain threshold was measured by pressure pain threshold gauge (PTG).

Secondary Outcome Measures

Name	Time	Method
The Hamilton Depression Scale-17 (HAMD-17) Scores	Baseline	The HAMD scale is the most commonly used in the clinical assessment of depression, including 17 items. The higher the score, the more severe the depression. 0-6 means no depressive symptoms, 7-16 means mild depression, 17-24 was divided into moderate depression, and more than 25 was divided into severe depression.
The Patient Health Questionaire-9 Items (PHQ -9)	Baseline	The PHQ-9 scale has a total of 9 questions, each with a score of 0-3 (none: 0; a few days: 1; more than half of the time: 2; almost every day: 3), with a total score of 0-27.
The Self-Rating Depression Scale (SDS) Scores	Baseline	The standard score is the total of all scores multiplied by 1.25 to the nearest whole number on this scale, which has 20 questions. A standard score below 50 is normal; 53-62 is mild depression; 63-72 is moderate depression; 72 or more is severe depression.

Trial Locations

Locations (1)

the Third affiliated hospital of Zhejiang Chinese Medical university; 🇨🇳 Hangzhou, Zhejiang, China