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

NCT05353543 | Unknown

• 1 other identifier: 2022ZX010-ABS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

acupuncture; biological specificity; major depressive disorder

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (6)

• Change in the Self-Rating Depression Scale (SDS)

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

• Temperature change

  Baseline, 6 weeks after treatment.

• Microcirculatory change

  Baseline, 6 weeks after treatment.

• Metabolic change

  Baseline, 6 weeks after treatment.

• Pain sensitivity change

  Baseline, 6 weeks after treatment.

Study Arms (3)

Acupuncture (strong reaction acupoints) group

EXPERIMENTAL

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.

Drug: SSRIs; Procedure: acupuncture (strong reaction acupoints)

Acupuncture (weak reaction acupoints) group

EXPERIMENTAL

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.

Drug: SSRIs; Procedure: acupuncture (weak reaction acupoints)

Sham acupuncture group

EXPERIMENTAL

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.

Drug: SSRIs; Procedure: sham acupuncture

Interventions

SSRIs DRUG

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

Also known as: SSRIs antidepressants

Acupuncture (strong reaction acupoints) group; Acupuncture (weak reaction acupoints) group; Sham acupuncture group

acupuncture (strong reaction acupoints) PROCEDURE

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.

Also known as: intradermal needle

Acupuncture (strong reaction acupoints) group

acupuncture (weak reaction acupoints) PROCEDURE

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.

Also known as: intradermal needle

Acupuncture (weak reaction acupoints) group

sham acupuncture PROCEDURE

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.

Also known as: sham intradermal needle

Sham acupuncture group

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;
• ≤ 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).
• 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;
• ≤ 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead
• The Zhejiang Provincial Tongde Hospital: collaborator
• The Affiliated Hangzhou First People's Hospital: collaborator

Study Sites (1)

the Third affiliated hospital of Zhejiang Chinese Medical university

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Selective Serotonin Reuptake Inhibitors; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Complementary Therapies; Therapeutics

Study Officials

• Xiaomei Shao, Ph.D

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaomei Shao, Ph.D

CONTACT

+8618957130287; shaoxiaomei@zcmu.edu.cn

Mingqi Tu

CONTACT

+8615700067213; 403712321@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: April 29, 2022
• Study Start: May 1, 2022
• Primary Completion: May 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)