Clinical trial NCT06896994: Esketamine Combined Pregabalin and Duloxetine for Postherpetic Neuralgia
Official title: Intravenous Infusion of Esketamine in Combination With Pregabalin and Duloxetine for Postherpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postherpetic Neuralgia
Keywords: Postherpetic Neuralgia
esketamine
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Xiaotangshan Hospital
name: The First Hospital of Fangshan District,Beijing
name: Beijing Ditan Hospital
name: Hengshui People's Hospital
First posted: 2025-03-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Eligibility criteria: Inclusion Criteria:

1. Ages more than 18 years;
2. Pain present for more than 3 months after healing of a herpes zoster skin rash;
3. Has an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0= no pain, 10= worst possible pain)；
4. Failed to respond to or tolerate the effective dose of pregabalin monotherapy.

Exclusion Criteria:

1. Obstructive sleep apnoea syndrome;
2. Those who receive interventional treatments;
3. A history of systemic immune diseases, organ transplantation, or cancers;
4. A history of severe cardiopulmonary, hepatic or renal dysfunction;
5. A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
6. Currently using monoamine oxidase inhibitors (MAOIs);
7. Having untreated angle-closure glaucoma;
8. Those suffering from increased intracranial pressure；
9. Comorbid hyperthyroidism or phaeochromocytoma;
10. Suspected or confirmed history of drug abuse;
11. Having contraindications to esketamine, pregabaline or duloxetine;
12. Communication difficulties;
13. Women who are preparing for pregnancy, in the pregnancy or lactation period.

Primary outcomes:
measure: the mean of daily pain scores
timeFrame: during 1 week
Secondary outcomes:
measure: Averaged weekly NRS score
timeFrame: 1 week, 2 weeks, 3 weeks, and 1 month after treatment
measure: percentages of patients having >50% reductions in 24-hour average pain severity during the first week
timeFrame: during the first week
measure: the 12-item Short-Form Health Survey (SF-12) score
timeFrame: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment
measure: the Pittsburgh Sleep Quality Index (PSQI) score
timeFrame: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment
measure: the Patient Global Impression of Change scale (PGIC)
timeFrame: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment
measure: Averaged weekly analgesic consumption
timeFrame: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment
measure: Safety assessments
timeFrame: 0 day, 1 day, 3 days, 7 days, 2 weeks,3 weeks, and 1 month after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Fang Luo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: