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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06449547
Other study ID # TJ-IRB202401075
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date December 2026

Study information

Verified date June 2024
Source Huazhong University of Science and Technology
Contact Yang Shuguang, M.D
Phone (+86)15071078161
Email yangsuperpro@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to explore risk factors of anxiety and depression in patients with herpes zoster neuralgia, and the changes of certain serum biomarkers and functional brain magnetic resonance images of these patients.


Description:

Patients with herpes zoster neuralgia will be recruited and take Hospital anxiety depression rating scale (Hospital anxiety and 'scale, HADS) evaluation. According to the HADS Scores, patients will be divided into depression group and no depression, or anxiety group and no anxiety group. The clinical data the of two groups will be collected and statistically analyzed to explore the risk factors of anxiety and depression, including the changes of serum biomarkers and functional brain magnetic resonance imaging in patients with herpes zoster neuralgia accompanying anxiety or depression.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 600
Est. completion date December 2026
Est. primary completion date May 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age more than 18 years old 2. Diagnosed as herpes zoster neuralgia 3. Signing informed consent Exclusion Criteria: 1. Unable to complete the scale assessment 2. History of mental illness

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale questionnaire is used to test patients for anxiety and depression.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Huazhong University of Science and Technology

References & Publications (1)

Du J, Sun G, Ma H, Xiang P, Guo Y, Deng Y, Li S, Li X. Prevalence and Risk Factors of Anxiety and Depression in Patients with Postherpetic Neuralgia: A Retrospective Study. Dermatology. 2021;237(6):891-895. doi: 10.1159/000512190. Epub 2020 Dec 16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary HADS score Enrolled patients will be first evaluated by Hospital Anxiety and Depression Scare questionaire and according to the HADS score, patients will be divided to group with anxiety/depression and group without anxiety/depression. during hospital stay, average of 1 week
Secondary Interleukin (IL)-1ß plasma level Blood sample will be obtained from enrolled patients and the plasma level of inflammatory cytokines IL-1ß (pg/ml)will be tested. during hospital stay, average of 1 week
Secondary IL-2 receptor plasma level Blood sample will be obtained from enrolled patients and the plasma level of inflammatory cytokines IL-2 (u/ml)will be tested. during hospital stay, average of 1 week
Secondary IL-6 plasma level Blood sample will be obtained from enrolled patients and the plasma level of inflammatory cytokines IL-6 (pg/ml)will be tested. during hospital stay, average of 1 week
Secondary IL-8 plasma level Blood sample will be obtained from enrolled patients and the plasma level of inflammatory cytokines IL-8 (pg/ml)will be tested. during hospital stay, average of 1 week
Secondary IL-10 plasma level Blood sample will be obtained from enrolled patients and the plasma level of inflammatory cytokines IL-10 (pg/ml)will be tested. during hospital stay, average of 1 week
Secondary Interferon(INF)-a plasma level Blood sample will be obtained from enrolled patients and the plasma level of inflammatory cytokines INF-a (pg/ml)will be tested. during hospital stay, average of 1 week
Secondary Brain-derived neurotrophic factor (BDNF) plasma level Blood sample will be obtained from enrolled patients and the plasma level of BDNF(pg/ml)will be tested. during hospital stay, average of 1 week
Secondary C-reactive protein (CRP) plasma level Blood sample will be obtained from enrolled patients and the plasma level of CRP(mg/ml)will be tested. during hospital stay, average of 1 week
Secondary Area under curve (AUC) of topological metrics of functional brain magnetic resonance imaging Functional brain magnetic resonance imaging will be performed in patients with anxiety or depression, and area under curve (AUC) of topological metrics including Eglob,Eloc,Cp,Lp,?,? and s will be calculated and analyzed. during hospital stay, average of 1 week
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