Clinical trial NCT06114342: The Biological Specificity of Acupoints Between Major Depressive Disorder Patients and Healthy Controls
Official title: The Biological Specificity of Acupoints Between Major Depressive Disorder Patients and Healthy Controls: A Prospective, Assessor-blinded, Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Acupoint
Biological specificity
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
Collaborators: name: Zhejiang Provincial Tongde Hospital
name: First People's Hospital of Hangzhou
First posted: 2023-11-02
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The diagnostic criteria of MDD were based on criteria proposed by the International Classification of Diseases 10th Edition (ICD-10). Healthy control participants were determined by a recent depression screening report for confirming their mental health conditions.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Temperature
timeFrame: Baseline
measure: Pressure pain threshold
timeFrame: Baseline
Secondary outcomes:
measure: The Hamilton Depression Scale-17 (HAMD-17) Scores
timeFrame: Baseline
measure: The Patient Health Questionaire-9 Items (PHQ -9)
timeFrame: Baseline
measure: The Self-Rating Depression Scale (SDS) Scores
timeFrame: Baseline
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Third affiliated hospital of Zhejiang Chinese Medical university
state: Zhejiang
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Xiaomei Shao
role: PRINCIPAL_INVESTIGATOR
References: