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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Huazhong University of Science and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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