The Biological Specificity of Acupoints Between Major Dep... | NCT06114342

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

NCT06114342

Sponsor

Xiaomei Shao

Status

Completed

Last Update Posted

Mar 15, 2024Actual

Enrollment

184Actual

Phase

Not provided

Conditions

Major Depressive Disorder

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2022Actual

Primary Completion Date

Sep 30, 2022Actual

Completion Date

Sep 30, 2022Actual

First Submitted Date

Oct 28, 2023

First Submission Date that Met QC Criteria

Oct 28, 2023

First Posted Date

Nov 2, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2024

Last Update Posted Date

Mar 15, 2024Actual

Name	Class
Zhejiang Provincial Tongde Hospital	OTHER
First People's Hospital of Hangzhou	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

184Actual

Label	Type	Description	Intervention Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	Baseline

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders