Esketamine Combined Pregabalin and Duloxetine for Postherpetic Neuralgia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: esketamine group, control group.
- Who it may be relevant to
- Registry conditions: Postherpetic Neuralgia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intravenous Infusion of Esketamine in Combination With Pregabalin and Duloxetine for Postherpetic Neuralgia
Overview
To assess the 1-week effects and safety of esketamine in combination with pregabalin and duloxetine to relieve pain in patients with postherpetic Neuralgia(PHN).
Detailed description
The investigators aim to investigate whether or not esketamine combined with pregabalin and duloxetine to relieve pain in patients with PHN, and seek a rapid, effective and safe treatment for refractory patients with PHN
Interventions
- Drug esketamine group
In the esketamine group, in addition to receiving the combination of pregabalin and duloxetine, patients will also undergo a single intravenous infusion of esketamine. - Drug control group
receiving the combination of pregabalin and duloxetine
Primary outcome measures
- the mean of daily pain scores [Time frame: during 1 week]
Secondary outcome measures (8)
- Averaged weekly NRS score [Time frame: 1 week, 2 weeks, 3 weeks, and 1 month after treatment]
- percentages of patients having >50% reductions in 24-hour average pain severity during the first week [Time frame: during the first week]
- the 12-item Short-Form Health Survey (SF-12) score [Time frame: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment]
- the Pittsburgh Sleep Quality Index (PSQI) score [Time frame: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment]
- the Patient Global Impression of Change scale (PGIC) [Time frame: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment]
- The Hospital Anxiety and Depression Scale (HADS) [Time frame: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment]
- Averaged weekly analgesic consumption [Time frame: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment]
- Safety assessments [Time frame: 0 day, 1 day, 3 days, 7 days, 2 weeks,3 weeks, and 1 month after treatment]
Eligibility criteria
Inclusion criteria
- Ages more than 18 years;
- Pain present for more than 3 months after healing of a herpes zoster skin rash;
- Has an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0= no pain, 10= worst possible pain)；
- Failed to respond to or tolerate the effective dose of pregabalin monotherapy.
Exclusion criteria
- Obstructive sleep apnoea syndrome;
- Those who receive interventional treatments;
- A history of systemic immune diseases, organ transplantation, or cancers;
- A history of severe cardiopulmonary, hepatic or renal dysfunction;
- A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
- Currently using monoamine oxidase inhibitors (MAOIs);
- Having untreated angle-closure glaucoma;
- Those suffering from increased intracranial pressure；
- Comorbid hyperthyroidism or phaeochromocytoma;
- Suspected or confirmed history of drug abuse;
- Having contraindications to esketamine, pregabaline or duloxetine;
- Communication difficulties;
- Women who are preparing for pregnancy, in the pregnancy or lactation period.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Tiantan Hospital — Beijing
Identifiers
NCT: NCT06896994 · KY-2024-332-02-02