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Acupuncture Therapy Based on Biological Specificity of Acupoints for Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

SSRIs

acupuncture (strong reaction acupoints)

acupuncture (weak reaction acupoints)

sham acupuncture

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring acupuncture, biological specificity, major depressive disorder

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Inclusion criteria for health volunteers:
- Healthy volunteers who could provide a recent depression screening report, and confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological disease;
- 12 ≤ age ≤60 years, male or female;
- Participants have clear consciousness and could communicate with others normally;
- Participants could understand the full study protocol and have high adherence. Written informed consent is signed by themselves or their lineal kin (for minor participants, their guardian should sign the informed consent form for them).
Inclusion criteria for MDD:
- Patients should meet the diagnostic criteria of the International Classification of Diseases 10th Edition (ICD-10) diagnostic criteria for depression and are evaluated as moderate or severe MDD according to the severity of depression;
- 12 ≤ age ≤60, male or female;
- Participants have clear consciousness and could communicate with others normally;
- Participants could understand the full study protocol and have high adherence. Written informed consent is signed by themselves or their lineal kin (for minor participants, their guardian should sign the informed consent form for them).

Exclusion Criteria:

Exclusion criteria of health volunteers:
- Participants with serious primary diseases of cardiovascular diseases, liver diseases, kidney diseases, urinary diseases, and hematological diseases;
- Participants have a mental illness, alcohol dependence, or a history of drug abuse;
- Pregnant or lactating participants;
- Participants are participating in other trials.
Exclusion criteria for MDD:
- Participants with serious primary diseases of cardiovascular, respiratory, digestive, urinary, hematological, endocrine, neurological disease, and other serious primary diseases, and the disease cannot be effectively controlled clinically;
- Major depressive disorders caused by organic mental disorders, schizophrenia, bipolar disorder, psychoactive substances, and non-addictive substances;
- Participants with suicidal tendencies;
- Pregnant or lactating participants;
- Participants taking other antidepressants that were not SSRIs or the pharmacological effects of such antidepressants have not been cleared;
- Participants with intellectual disabilities who cannot cooperate with the questionnaire survey;
- Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape;
- The skin at the test site of participants has scars, hyperpigmentation, red and swollen;
- Participants are participating in other trials.

Sites / Locations

the Third affiliated hospital of Zhejiang Chinese Medical university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Acupuncture (strong reaction acupoints) group

Acupuncture (weak reaction acupoints) group

Sham acupuncture group

Arm Description

This group will include 40 patients with MDD who will be treated with acupuncture and SSRIs antidepressants. Strong reaction acupoints selected in the first part of the study will be stimulated. The oral dose of SSRIs antidepressants will be determined by the clinical specialist.

This group will include 40 patients with MDD who will be treated with acupuncture and SSRIs antidepressants. Weak reaction acupoints selected in the first part of the study will be stimulated. The oral dose of SSRIs antidepressants will be determined by the clinical specialist.

This group will include 40 patients with MDD who will be treated with sham acupuncture and SSRIs antidepressants. The sham acupuncture will be needled on the points 1cm lateral to strong reaction acupoints. The oral dose of SSRIs antidepressants will be determined by the clinical specialist.

Outcomes

Primary Outcome Measures

Change in 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.

Secondary Outcome Measures

Change in the Self-Rating Depression Scale (SDS)

This scale has 20 questions. Participants should choose the answer that best matches their situation based on their feelings in the last week or less. Depression severity = total score/80 (0-0.5 means no depression, 0.5-0.59 means mild depression, 0.6-0.69 means moderate depression, and 0.7 or more means severe depression).

Temperature change

NEC R450 Infrared thermography will be used to record baseline temperature and the temperature change of relevant sites. The average temperature value of relevant sites in the six infrared thermograms is its base temperature.

Microcirculatory change

The PeriFlux System 5000 is a four-channel laser Doppler flowmeter that detects the rate of blood cell movement and its distribution of relevant test sites. The accompanying Perisoft for Windows flow analysis software generates the blood flow curve and analyzes the microcirculatory perfusion unit (PU) at the relevant test site and the 10 min average is used as the base PU.

Metabolic change

The INVOS 5100C quad-channel NIR spectrometer detects regional oxygen saturation (rSO2). rSO2 is analyzed by the INVOS Analytics Tool software and the 10 min average is used as the base rSO2.

Pain sensitivity change

A Digital pressure pain gauge will be used to measure the local pain threshold (PT). The probe of the pain gauge will be placed vertically on the relevant test site, and the pressure will be applied slowly and steadily, and when the participant feels pain, the pressure will stop and the reading on the gauge is the PT. The average value of the PT of the same relevant test sites will be calculated as their base PT.

Adverse Events

Any adverse events that occur during the trial will be recorded and analyzed for the cause.

Full Information

NCT ID

NCT05353543

First Posted

April 27, 2022

Last Updated

April 28, 2022

Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Collaborators

The Zhejiang Provincial Tongde Hospital, The Affiliated Hangzhou First People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05353543

Brief Title

Acupuncture Therapy Based on Biological Specificity of Acupoints for Major Depressive Disorder

Official Title

Acupuncture Therapy Based on Biological Specificity of Acupoints for Major Depressive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 1, 2022 (Anticipated)

Primary Completion Date

May 30, 2025 (Anticipated)

Study Completion Date

December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Collaborators

The Zhejiang Provincial Tongde Hospital, The Affiliated Hangzhou First People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Acupoints are the stimulus points and reactive points for acupuncture to treat the diseases. Therefore, this study is designed to detect the biological specificity of acupoints in healthy participants and major depressive disorder (MDD) participants by using multiple objective assessment tools. And then acupoints that are statistically different between the two groups will be defined as strong reaction points, and other acupoints without statistically different will be defined as weak response points. In addition, this clinical trial will be conducted to explore whether the efficacy of stimulating strong reaction acupoints is more effective than weak reaction points, thereby confirming the specificity of the acupoint.

Detailed Description

Part 1: This study will include 40 patients with MDD and 40 healthy control participants. Infrared thermography (IRT), laser doppler flowmetry (LDF), functional near-infrared spectroscopy (FNIS), and digital pressure pain gauge (PPG), respectively, will be adopted to assess 4 kinds of biological specificity of MDD related acupoints, namely, the thermal transport specificity, the microcirculatory specificity, the metabolic specificity, and the pain sensitivity specificity. Based on the results of this study, we will select acupoints with statistical differences between the two groups as the strong reaction acupoints and the remaining acupoints as the weak reaction acupoints. Part 2: A total of 120 participants with MDD who meet the inclusion criteria will be included in the study. All participants will receive basic treatment of selective serotonin reuptake inhibitors (SSRIs) antidepressants. They will be randomly divided into the acupuncture (strong reaction acupoints) group, acupuncture (weak reaction acupoints) group, and sham acupuncture group. We will evaluate the therapeutic effect and safety of acupuncture for MDD, furthermore, to demonstrate whether stimulating strong reaction acupoints has more advantages in the treatment of MDD than weak reaction acupoints.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

acupuncture, biological specificity, major depressive disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture (strong reaction acupoints) group

Arm Type

Experimental

Arm Description

Arm Title

Acupuncture (weak reaction acupoints) group

Arm Type

Experimental

Arm Description

Arm Title

Sham acupuncture group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

SSRIs

Other Intervention Name(s)

SSRIs antidepressants

Intervention Description

In this study, SSRIs antidepressants will be used, and the oral dose will be determined by the clinical specialist. Once-daily for 6 weeks.

Intervention Type

Procedure

Intervention Name(s)

acupuncture (strong reaction acupoints)

Other Intervention Name(s)

intradermal needle

Intervention Description

This study will use the intradermal needle as an acupuncture intervention. Strong reaction acupoints selected in the first part of the study will be stimulated. According to the position of the acupoints, choose a needle of φ0.20*1.5m or φ0.20*1.2mm. Press the needle to insert the acupoint vertically and retain it in the skin. After the intervention, the needle will be retained for 72 hours with a day of rest after removal. During needle retention, participants will be instructed to press the acupoints 3-4 times a day for about 1 minute each time, with the amount of stimulation as much as the patient can tolerate, at an interval of about 4 hours. A total of 10 treatment sessions will be performed for 6 weeks.

Intervention Type

Procedure

Intervention Name(s)

acupuncture (weak reaction acupoints)

Other Intervention Name(s)

intradermal needle

Intervention Description

This study will use the intradermal needle as an acupuncture intervention. Weak reaction acupoints selected in the first part of the study will be stimulated. According to the position of the acupoints, choose a needle of φ0.20*1.5m or φ0.20*1.2mm. Press the needle to insert the acupoint vertically and retain it in the skin. After the intervention, the needle will be retained for 72 hours with a day of rest after removal. During needle retention, participants will be instructed to press the acupoints 3-4 times a day for about 1 minute each time, with the amount of stimulation as much as the patient can tolerate, at an interval of about 4 hours. A total of 10 treatment sessions will be performed for 6 weeks.

Intervention Type

Procedure

Intervention Name(s)

sham acupuncture

Other Intervention Name(s)

sham intradermal needle

Intervention Description

Sham acupuncture will use the same size, color, and material as the verum intradermal needle with a thin silicone pad in the middle instead of the needle body. The sham acupuncture will be needled on the points 1cm lateral to strong reaction acupoints. After the intervention, the needle will be retained for 72 hours with a day of rest after removal. A total of 10 sessions will be performed for 6 weeks.

Primary Outcome Measure Information:

Title

Change in the Patient Health Questionaire-9 Items (PHQ -9)

Description

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 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.

Secondary Outcome Measure Information:

Title

Change in the Self-Rating Depression Scale (SDS)

Description

Time Frame

Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.

Title

Temperature change

Description

Time Frame

Baseline, 6 weeks after treatment.

Title

Microcirculatory change

Description

Time Frame

Baseline, 6 weeks after treatment.

Title

Metabolic change

Description

The INVOS 5100C quad-channel NIR spectrometer detects regional oxygen saturation (rSO2). rSO2 is analyzed by the INVOS Analytics Tool software and the 10 min average is used as the base rSO2.

Time Frame

Baseline, 6 weeks after treatment.

Title

Pain sensitivity change

Description

Time Frame

Baseline, 6 weeks after treatment.

Title

Adverse Events

Description

Any adverse events that occur during the trial will be recorded and analyzed for the cause.

Time Frame

Up to 10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Inclusion criteria for health volunteers: Healthy volunteers who could provide a recent depression screening report, and confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological disease; 12 ≤ age ≤60 years, male or female; Participants have clear consciousness and could communicate with others normally; Participants could understand the full study protocol and have high adherence. Written informed consent is signed by themselves or their lineal kin (for minor participants, their guardian should sign the informed consent form for them). Inclusion criteria for MDD: Patients should meet the diagnostic criteria of the International Classification of Diseases 10th Edition (ICD-10) diagnostic criteria for depression and are evaluated as moderate or severe MDD according to the severity of depression; 12 ≤ age ≤60, male or female; Participants have clear consciousness and could communicate with others normally; Participants could understand the full study protocol and have high adherence. Written informed consent is signed by themselves or their lineal kin (for minor participants, their guardian should sign the informed consent form for them). Exclusion Criteria: Exclusion criteria of health volunteers: Participants with serious primary diseases of cardiovascular diseases, liver diseases, kidney diseases, urinary diseases, and hematological diseases; Participants have a mental illness, alcohol dependence, or a history of drug abuse; Pregnant or lactating participants; Participants are participating in other trials. Exclusion criteria for MDD: Participants with serious primary diseases of cardiovascular, respiratory, digestive, urinary, hematological, endocrine, neurological disease, and other serious primary diseases, and the disease cannot be effectively controlled clinically; Major depressive disorders caused by organic mental disorders, schizophrenia, bipolar disorder, psychoactive substances, and non-addictive substances; Participants with suicidal tendencies; Pregnant or lactating participants; Participants taking other antidepressants that were not SSRIs or the pharmacological effects of such antidepressants have not been cleared; Participants with intellectual disabilities who cannot cooperate with the questionnaire survey; Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape; The skin at the test site of participants has scars, hyperpigmentation, red and swollen; Participants are participating in other trials.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaomei Shao, Ph.D

Phone

+8618957130287

shaoxiaomei@zcmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Mingqi Tu

Phone

+8615700067213

403712321@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaomei Shao, Ph.D

Organizational Affiliation

The Third Affiliated hospital of Zhejiang Chinese Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

the Third affiliated hospital of Zhejiang Chinese Medical university

City

Hangzhou

State/Province

Zhejiang

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaomei Shao

Phone

+8618957130287

shaoxiaomei@zcmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Mingqi Tu

Phone

+8615700067213

403712321@qq.com

12. IPD Sharing Statement

Plan to Share IPD

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Acupuncture Therapy Based on Biological Specificity of Acupoints for Major Depressive Disorder

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