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

NCT06114342 | Completed

• 1 other identifier: 2022ZX010-IP
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Acupoint; Biological specificity

Outcome Measures

Primary Outcomes (2)

• Temperature

  Temperature of acupoints was measured by infrared thermography (IRT). IRT was not be performed on female subjects during their menstrual and ovulatory periods.

  Baseline

• Pressure pain threshold

  Pressure pain threshold was measured by pressure pain threshold gauge (PTG).

  Baseline

Secondary Outcomes (3)

• The Hamilton Depression Scale-17 (HAMD-17) Scores

  Baseline

• The Patient Health Questionaire-9 Items (PHQ -9)

  Baseline

• The Self-Rating Depression Scale (SDS) Scores

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• provided a recent depression screening report, and be free of any cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological disease;
• ≤ 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.
• consistent with the diagnosis of MDD in the International Classification of Diseases 10th Edition (ICD-10);
• ≤ 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.

Sponsors & Collaborators

• Xiaomei Shao: lead
• Zhejiang Provincial Tongde Hospital: collaborator
• First People's Hospital of Hangzhou: collaborator

Study Sites (1)

the Third affiliated hospital of Zhejiang Chinese Medical university

Hangzhou, Zhejiang, 310053, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Xiaomei Shao

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2023
• First Posted: November 2, 2023
• Study Start: January 10, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)