Clinical trial NCT05524519: Intradermal Acupuncture Based on Changes in Biological Specificity of Acupoints for Major Depressive Disorder
Official title: Intradermal Acupuncture Based on Changes in Biological Specificity of Acupoints for Major Depressive Disorder: a Prospective, Multicentre, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder
Intradermal acupuncture
Biological specificity
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
Collaborators: name: Zhejiang Provincial Tongde Hospital
name: First People's Hospital of Hangzhou
First posted: 2022-09-01
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acupoints are the stimulus points and reactive points for acupuncture to treat diseases. Therefore, this study is designed to detect the pain threshold and temperature of biological specificities of acupoints in healthy control (HC) participants and major depressive disorder (MDD) participants by using pressure pain threshold gauge (PTG) and infrared thermography (IRT). Based on the results of the PTG and IRT tests, the potentially superior acupoints for the treatment of MDD will be selected separately. Then, different acupoint groups selected based on different biological specificities tests will be used for clinical treatment to evaluate the clinical efficacy of intradermal acupuncture (IA) for MDD based on changes in the biological specificities of acupoints.

Detailed description: Part 1: This study will include 50 patients with MDD (MDD group) and 50 HC participants (HC group). PTG and IRT, respectively, will be adopted to assess 2 kinds of biological specificity of MDD-related acupoints: pain sensitivity specificity and thermal specificity. Based on the results of the PTG and IRT tests, the potentially superior acupoints for the treatment of MDD will be selected separately. After statistical analysis of the data from PTG and IRT tests, 4 pressure pain threshold strong response acupoints (PSA) and 4 temperature strong response acupoints (TSA) will be selected, respectively.

Part 2: A total of 160 participants with MDD who meet the inclusion criteria will be included in the study. Patients with MDD who met the criteria will be randomly divided 1:1:1:1 into 4 groups: waiting treatment (WT) group, clinical common acupoint (CCA) group, TSA group, and PSA group. All participants received basic therapeutic medication for the use of one or more antidepressants. Dosing and dosage will be adjusted by a specialist. The Patient Health Questionnare-9 (PHQ-9) and the MOS item short form health survey (SF-36) will be used as clinical efficacy outcome indicators, and each group's incidence of adverse effects will be observed. This study will investigate the effectiveness and safety of IA based on changes in the biological specificity of acupoints for MDD.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria for HC:

* HC who could provide a recent depression screening report, and confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological disease;
* 18 ≤ 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.

Inclusion criteria for MDD:

* Patients should meet the diagnostic criteria of the International Classification of Diseases 10th Edition (ICD-10) diagnostic criteria for MDD;
* 18 ≤ 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.

Exclusion Criteria:

Exclusion criteria of HC:

* 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 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.

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;
* MDD caused by organic mental disorders, schizophrenia, bipolar disorder, psychoactive substances, and non-addictive substances;
* Participants with suicidal tendencies;
* Pregnant or lactating participants;
* 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. IRT is not be performed on female subjects during their menstrual and ovulatory periods;
* Participants are participating in other trials.

Primary outcomes:
measure: Change in the Patient Health Questionaire-9 Items (PHQ -9)
timeFrame: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
Secondary outcomes:
measure: Change in the MOS item short form health survey (SF-36)
timeFrame: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
measure: Temperature change of relevant sites
timeFrame: Baseline, 6 weeks after treatment.
measure: Pain sensitivity change of relevant sites
timeFrame: Baseline, 6 weeks after treatment.
measure: Adverse Events
timeFrame: through study completion (up to 10 weeks).
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Third affiliated hospital of Zhejiang Chinese Medical university
state: Zhejiang
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Xiaomei Shao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: