- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04664530
The Study on the Esketamine in the Treatment of Postherpetic Neuralgia
December 6, 2020 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
Herpes zoster (HZ) is an acute herpetic skin disease caused by the reactivation of the varicella-zoster virus (VZV) latent in the sensory ganglia.
Postherpetic neuralgia (PHN) often occurs after herpes zoster heals and persists for a long time.
At present, clinically anticonvulsants (such as gabapentin, pregabalin) and antidepressants (such as amitriptyline) are clinically first-line drugs for the treatment of PHN, which are not usually effective to treat PHN well, as well as to alleviate patients' bad mental symptoms.
Esketamine, as a well-known N-methyl-D-aspartate receptor inhibitor, has both analgesic and antidepressant effects with extremely few incidence of respiratory depression, delirium, hallucinations, nausea and vomiting.
Therefore, we hypothesize that esketamine could relieve PHN and Anxiety and depression-like symptoms symptoms in patients with PHN.
This study intended to compare the efficacy of pregabalin, amitriptyline combined with esketamine therapy and pregabalin combined with amitriptyline therapy for alleviating PHN, and to further explore the feasibility and safety of esketamine in the treatment of PHN as well as underlying the mechanism of esketamine on the PHN.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Phase 4
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
- Name: Lieju Wang, Master
- Phone Number: 18758131223
- Email: 11518264@zju.edu.cn
Study Locations
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-
Zhejiang
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Hangzhou, Zhejiang, China, 310000
- Recruiting
- The Second Affiliated Hospital of Zhejiang University anesthesiology department
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-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-80 years old; Patients with post-herpetic neuralgia with anxiety and depression; NRS ≧4 points; A and (or) D ≧8 points in the Hospital Anxiety and Depression Scale (HADS) ; The course of disease ≧3 months; Patients with invalid conventional treatment (pregabalin or gabapentin combined with anti-anxiety depression, anti-epileptic dugs).
Exclusion Criteria:
- Present acute and chronic pain caused by other disease during treatment; Serious systemic disease; Severe infection, history of heart, lung, liver and kidney dysfunction, tumor, immunodeficiency and other serious diseases, or currently receiving or have recently received immunosuppression or cytotoxic drug treatment; A history of mental illness such as epilepsy, depression, Alzheimer's, multiple sclerosis, Parkinson, etc., and a history of head trauma; Participating in another clinical trial.
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group
|
The in-hospital intervention process is divided into a titration phase and an effect evaluation phase.
After admission, all patients received pregabalin 150mg twice for one day and amitriptyline 12.5mg one piece per night.
The treatment group was combined with intranasal esketamine three times per day, and individualized concentration titration was performed within 5 days.
Set the initial dosage to 10mg for nasal drops.
If the score is less than 5 points compared to the basic value, the dose is increased by 5 mg each time.
When the dose reaches 25mg, the increment of the dose will be adjusted to 10mg.
If the score is reduced by ≥5 points compared to the basic value, the current dose will be maintained and the titration will end.
The titration phase will be finished when the titration dose reaches 35mg or untolerable adverse reactions occurs.
Finally, a 7 tesla scan was performed on the right-hand patients with herpes on the body to explore the effect of ketamine on the brain network.
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Placebo Comparator: Control group
|
The titration process in the control group with saline are the same as those in the treatment group with esketamine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric rating scales
Time Frame: Baseline, once for the period of drug administration
|
The score to assess the pain degree
|
Baseline, once for the period of drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Min Yan, Doctor, The second affiliated hospital of Zhejiang University hangzhou, Zhejiang, China
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)
November 25, 2020
Primary Completion (Anticipated)
June 1, 2022
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
December 6, 2020
First Submitted That Met QC Criteria
December 6, 2020
First Posted (Actual)
December 11, 2020
Study Record Updates
Last Update Posted (Actual)
December 11, 2020
Last Update Submitted That Met QC Criteria
December 6, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-1035
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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