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RecruitingNCT06449547Updated Aug 26, 2024

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

An observational study in Herpes Zoster, sponsored by Huazhong University of Science and Technology. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-26.

Sponsored by Huazhong University of Science and Technology · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
600
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Herpes Zoster

Keywords

  • Anxiety
  • Depression
  • Herpes Zoster
  • Neuralgia
03

In context

Herpes Zoster

370 studies on the registry are indexed under Herpes Zoster; 63 are open to participants now.

This study's planned enrollment of 600 is above the median of 355 across 51 observational studies indexed under Herpes Zoster.

Browse Herpes Zoster studies →

Lead sponsor

Huazhong University of Science and Technology is the lead sponsor of 246 studies on the registry; 62 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age more than 18 years old
  2. Diagnosed as herpes zoster neuralgia
  3. Signing informed consent

Exclusion criteria

Exclusion Criteria:

  1. Unable to complete the scale assessment
  2. History of mental illness
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • 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

  • 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

  • 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

Interventions

  • Diagnostic testHospital Anxiety and Depression Scale

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: during hospital stay, average of 1 week

Secondary outcomes

  1. Interleukin (IL)-1β plasma level

    Blood sample will be obtained from enrolled patients and the plasma level of inflammatory cytokines IL-1β (pg/ml)will be tested.

    Time frame: during hospital stay, average of 1 week

  2. 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.

    Time frame: during hospital stay, average of 1 week

  3. 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.

    Time frame: during hospital stay, average of 1 week

  4. 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.

    Time frame: during hospital stay, average of 1 week

  5. 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.

    Time frame: during hospital stay, average of 1 week

  6. Interferon(INF)-α plasma level

    Blood sample will be obtained from enrolled patients and the plasma level of inflammatory cytokines INF-α (pg/ml)will be tested.

    Time frame: during hospital stay, average of 1 week

  7. 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.

    Time frame: during hospital stay, average of 1 week

  8. 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.

    Time frame: during hospital stay, average of 1 week

  9. 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,γ,λ and σ will be calculated and analyzed.

    Time frame: during hospital stay, average of 1 week

07

Study locations

1 of 1 sites recruiting
  • Tongji hospital
    Wuhan, Hubei 430031, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 33326962 ↗

Individual participant data

Plan to share: No — no plan to make individual participant data (IPD) available to other researchers

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06449547
Responsible party
Wei Mei (Deputy director of anesthesiology, Huazhong University of Science and Technology) — Principal investigator
First posted
Jun 10, 2024
Start date
Jun 21, 2024
Primary completion
May 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Aug 26, 2024

Study contacts

Yang Shuguang, M.D
Contact
yangsuperpro@163.com
(+86)15071078161
Mei wei, M.D, PhD
Contact
wmei@hust.edu.cn
(+86)13006162508
Yang Shuguang, M.D
principal investigator · Tongji medical college of Huazhong University of Science and technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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