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

Sponsor

Xiaomei Shao (Other)

Overall Status

Completed

CT.gov ID

NCT06114342

Collaborator

Zhejiang Provincial Tongde Hospital (Other), First People's Hospital of Hangzhou (Other)

184

Enrollment

Location

8.6

Actual Duration (Months)

21.3

Patients Per Site Per Month

Study Details

Study Description

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. We conducted a comparative study involving MDD patients and healthy subjects, employing modern techniques to discern biological specificity in MDD-related acupoints. Additionally, we investigated potential correlations between acupoint biological specificity and MDD severity.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder

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 Design

Study Type:

Observational

Actual Enrollment :

184 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

The Biological Specificity of Acupoints Between Major Depressive Disorder Patients and Healthy Controls: A Prospective, Assessor-blinded, Comparative Study

Actual Study Start Date :

Jan 10, 2022

Actual Primary Completion Date :

Sep 30, 2022

Actual Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
HC group There were 50 healthy control participants in the HC group.
MDD group There were 84 MDD patients in the MDD group. 50 MDD subjects were enrolled at each acupoint for each test.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Inclusion criteria for the healthy control participants: (1) provided a recent depression screening report, and be free of any cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological disease; (2) 18 ≤ age ≤60 years, male or female; (3) had clear consciousness and could communicate with others normally; (4) understand the full study protocol and have high adherence; (5) signed the written informed consent. Inclusion criteria for the MDD participants: (1) consistent with the diagnosis of MDD in the International Classification of Diseases 10th Edition (ICD-10); (2) 18 ≤ age ≤ 60, male or female; (3) had clear consciousness and could communicate with others normally; (4) understand the full study protocol and have high adherence; (5) 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.