Acupuncture Therapy Based on Biological Specificity of Acupoints for Major Depressive Disorder
NCT ID: NCT05353543
Last Updated: 2022-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2022-05-01
2025-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Acupuncture (strong reaction acupoints) group
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.
SSRIs
In this study, SSRIs antidepressants will be used, and the oral dose will be determined by the clinical specialist. Once-daily for 6 weeks.
acupuncture (strong reaction acupoints)
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.
Acupuncture (weak reaction acupoints) group
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.
SSRIs
In this study, SSRIs antidepressants will be used, and the oral dose will be determined by the clinical specialist. Once-daily for 6 weeks.
acupuncture (weak reaction acupoints)
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.
Sham acupuncture group
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.
SSRIs
In this study, SSRIs antidepressants will be used, and the oral dose will be determined by the clinical specialist. Once-daily for 6 weeks.
sham acupuncture
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.
Interventions
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SSRIs
In this study, SSRIs antidepressants will be used, and the oral dose will be determined by the clinical specialist. Once-daily for 6 weeks.
acupuncture (strong reaction acupoints)
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.
acupuncture (weak reaction acupoints)
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.
sham acupuncture
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
* 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
* 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.
12 Years
60 Years
ALL
Yes
Sponsors
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The Zhejiang Provincial Tongde Hospital
UNKNOWN
The Affiliated Hangzhou First People's Hospital
UNKNOWN
The Third Affiliated hospital of Zhejiang Chinese Medical University
OTHER
Responsible Party
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Xiaomei Shao
Prof
Principal Investigators
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Xiaomei Shao, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The Third Affiliated hospital of Zhejiang Chinese Medical University
Locations
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the Third affiliated hospital of Zhejiang Chinese Medical university
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Xiaomei Shao
Role: primary
Mingqi Tu
Role: backup
Other Identifiers
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2022ZX010-ABS
Identifier Type: -
Identifier Source: org_study_id