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CompletedNCT06114342Updated Mar 15, 2024

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

An observational study in Major Depressive Disorder, sponsored by Xiaomei Shao. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Xiaomei Shao · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
184
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Major Depressive Disorder

Keywords

  • Major Depressive Disorder
  • Acupoint
  • Biological specificity
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 184 is above the median of 150 across 653 observational studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Xiaomei Shao is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
184 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Temperature

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

    Time frame: Baseline

  2. Pressure pain threshold

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

    Time frame: Baseline

Secondary outcomes

  1. The Hamilton Depression Scale-17 (HAMD-17) Scores

    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.

    Time frame: Baseline

  2. The Patient Health Questionaire-9 Items (PHQ -9)

    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.

    Time frame: Baseline

  3. The Self-Rating Depression Scale (SDS) Scores

    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.

    Time frame: Baseline

07

Study locations

1 site
  • the Third affiliated hospital of Zhejiang Chinese Medical university
    Hangzhou, Zhejiang 310053, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06114342
Lead sponsor
Xiaomei Shao
Collaborators
Zhejiang Provincial Tongde Hospital, First People's Hospital of Hangzhou
Responsible party
Xiaomei Shao (Professor, The Third Affiliated hospital of Zhejiang Chinese Medical University) — Sponsor-investigator
First posted
Nov 2, 2023
Start date
Jan 10, 2022
Primary completion
Sep 30, 2022
Completion
Sep 30, 2022
Last update
Mar 15, 2024

Study contacts

Xiaomei Shao
principal investigator · The Third Affiliated hospital of Zhejiang Chinese Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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