Herpes ZosterNCT06449547
Risk Factors of Anxiety and Depression in Patients With Herpes Zoster Neuralgia
An observational study of Herpes Zoster, run by Huazhong University of Science and Technology at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Hospital Anxiety and Depression Scale
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will be conducted in patients who are diagnosed as herpes zoster neuralgia
Who may be able to join
- Age more than 18 years old
- Diagnosed as herpes zoster neuralgia
- Signing informed consent
Who cannot join
- Unable to complete the scale assessment
- History of mental illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji hospital
Wuhan, Hubei, 430031
Yang Shuguang, Master, 15071078161, yangsuperpro@163.com
About this study
Official title: 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.
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.
- Conditions
- Herpes Zoster
- Being tested
- Hospital Anxiety and Depression Scale
- Keywords
- Anxiety, Depression, Herpes Zoster, Neuralgia
- Medical subject headings
- Herpes Zoster, Anxiety Disorders, Depression, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital Anxiety and Depression ScaleDiagnostic test
Hospital Anxiety and Depression Scale questionnaire is used to test patients for anxiety and depression.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Hospital Anxiety and Depression Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during hospital stay, average of 1 week
Secondary outcomes (9)
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.
Measured: during hospital stay, average of 1 week
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.
Measured: during hospital stay, average of 1 week
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.
Measured: during hospital stay, average of 1 week
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.
Measured: during hospital stay, average of 1 week
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.
Measured: during hospital stay, average of 1 week
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.
Measured: during hospital stay, average of 1 week
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.
Measured: during hospital stay, average of 1 week
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.
Measured: during hospital stay, average of 1 week
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.
Measured: during hospital stay, average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start21 Jun 2024
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Mei, Huazhong University of Science and Technology
- Investigators
- Yang Shuguang, M.D, Principal investigator, Tongji medical college of Huazhong University of Science and technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449547
- Sponsor's protocol ID
- TJ-IRB202401075
- Status last verified
- Aug 2024
- First submitted
- 19 May 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to make individual participant data (IPD) available to other researchers
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Analysis of Anxiety and Depression in Patients With Herpes Zoster Neuralgia and Characteristics of Serum Biomarkers and Functional Brain Magnetic Resonance Changes
- ClinicalTrials.gov ID
- NCT06449547
- Acronym / sponsor ID
- TJ-IRB202401075
- Conditions
- Herpes Zoster
- Keywords
- Anxiety, Depression, Herpes Zoster, Neuralgia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| patients with anxiety | – | Diagnostic Test: Hospital Anxiety and Depression ScalePatients 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. |
| patients without anxiety | – | Diagnostic Test: Hospital Anxiety and Depression ScalePatients in this group suffered from herpes zoster neuralgia and had a score less than 8 for Hospital Anxiety and Depression Scale- Anxiety questionnaire. |
| patients with depression | – | Diagnostic Test: Hospital Anxiety and Depression ScalePatients 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. |
| patients without depression | – | Diagnostic Test: Hospital Anxiety and Depression ScalePatients in this group suffered from herpes zoster neuralgia and had a score less than 8 for Hospital Anxiety and Depression Scale- Depression questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted in patients who are diagnosed as herpes zoster neuralgia
Key inclusion criteria (3 listed)
- Age more than 18 years old
- Diagnosed as herpes zoster neuralgia
- Signing informed consent
Key exclusion criteria (2 listed)
- Unable to complete the scale assessment
- History of mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hospital Anxiety and Depression ScaleHospital Anxiety and Depression Scale questionnaire is used to test patients for anxiety and depression. | Diagnostic test | patients with anxiety, patients with depression, patients without anxiety, patients without depression |
Primary outcome
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.
9 secondary outcomes
Interleukin (IL）-1β plasma level
Time frame: during hospital stay, average of 1 week
IL-2 receptor plasma level
Time frame: during hospital stay, average of 1 week
IL-6 plasma level
Time frame: during hospital stay, average of 1 week
IL-8 plasma level
Time frame: during hospital stay, average of 1 week
IL-10 plasma level
Time frame: during hospital stay, average of 1 week
Interferon(INF)-α plasma level
Time frame: during hospital stay, average of 1 week
Brain-derived neurotrophic factor (BDNF) plasma level
Time frame: during hospital stay, average of 1 week
C-reactive protein (CRP) plasma level
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Background: PubMed 33326962Du 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.
- Individual participant dataSharing planned: No. no plan to make individual participant data (IPD) available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yang Shuguang, M.D principal investigator
Tongji medical college of Huazhong University of Science and technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Herpes Zoster, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Shuguang, M.D (（+86）15071078161, yangsuperpro@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HADS score (time frame: during hospital stay, average of 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06449547, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.