Risk Factors of Anxiety and Depression in Patients With Herpes Zoster Neuralgia

August 23, 2024 updated by: Wei Mei, Huazhong University of Science and Technology

Risk Factors Analysis of Anxiety and Depression in Patients With Herpes Zoster Neuralgia and Characteristics of Serum Biomarkers and Functional Brain Magnetic Resonance Changes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mei wei, M.D, PhD
  • Phone Number: (+86)13006162508
  • Email: wmei@hust.edu.cn

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430031
        • Recruiting
        • Tongji Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study will be conducted in patients who are diagnosed as herpes zoster neuralgia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with anxiety
Patients in this group suffered from herpes zoster neuralgia and had a score more than or equal to 8 for Hospital Anxiety and Depression Scale- Anxiety questionnaire.
Diagnostic test: Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale questionnaire is used to test patients for anxiety and depression.
patients without anxiety
Patients in this group suffered from herpes zoster neuralgia and had a score less than 8 for Hospital Anxiety and Depression Scale- Anxiety questionnaire.
Diagnostic test: Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale questionnaire is used to test patients for anxiety and depression.
patients with depression
Patients in this group suffered from herpes zoster neuralgia and had a score more than or equal to 8 for Hospital Anxiety and Depression Scale- Depression questionnaire.
Diagnostic test: Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale questionnaire is used to test patients for anxiety and depression.
patients without depression
Patients in this group suffered from herpes zoster neuralgia and had a score less than 8 for Hospital Anxiety and Depression Scale- Depression questionnaire.
Diagnostic test: Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale questionnaire is used to test patients for anxiety and depression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HADS score
Time Frame: during hospital stay, average of 1 week
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interleukin (IL）-1β plasma level
Time Frame: during hospital stay, average of 1 week
Blood sample will be obtained from enrolled patients and the plasma level of inflammatory cytokines IL-1β （pg/ml）will be tested.
during hospital stay, average of 1 week
IL-2 receptor plasma level
Time Frame: during hospital stay, average of 1 week
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
IL-6 plasma level
Time Frame: during hospital stay, average of 1 week
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
IL-8 plasma level
Time Frame: during hospital stay, average of 1 week
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
IL-10 plasma level
Time Frame: during hospital stay, average of 1 week
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
Interferon(INF)-α plasma level
Time Frame: during hospital stay, average of 1 week
Blood sample will be obtained from enrolled patients and the plasma level of inflammatory cytokines INF-α （pg/ml）will be tested.
during hospital stay, average of 1 week
Brain-derived neurotrophic factor (BDNF) plasma level
Time Frame: during hospital stay, average of 1 week
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
C-reactive protein (CRP) plasma level
Time Frame: during hospital stay, average of 1 week
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
Area under curve (AUC) of topological metrics of functional brain magnetic resonance imaging
Time Frame: during hospital stay, average of 1 week
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,γ,λ and σ will be calculated and analyzed.
during hospital stay, average of 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Investigators

  • Principal Investigator: Yang Shuguang, M.D, Tongji Medical College of Huazhong University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 19, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 23, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-IRB202401075

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan to make individual participant data (IPD) available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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