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

Xiaomei Shao

Status: Completed

Conditions: Major Depressive Disorder

Study type: Observational

Funder types: Other

Identifiers

NCT06114342

2022ZX010-IP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 184 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

184 participants in 2 patient groups

HC group

Description:

There were 50 healthy control participants in the HC group.

MDD group

Description:

There were 84 MDD patients in the MDD group. 50 MDD subjects were enrolled at each acupoint for each test.