Status:
COMPLETED
The Biological Specificity of Acupoints Between Major Depressive Disorder Patients and Healthy Controls
Lead Sponsor:
Xiaomei Shao
Collaborating Sponsors:
Zhejiang Provincial Tongde Hospital
First People's Hospital of Hangzhou
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-60 years
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 inv...
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT06114342
Start Date
January 10 2022
End Date
September 30 2022
Last Update
March 15 2024
Active Locations (1)
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1
the Third affiliated hospital of Zhejiang Chinese Medical university
Hangzhou, Zhejiang, China, 310053