Esketamine Combined Pregabalin and Duloxetine for Postherpetic Neuralgia

Not Applicable

Recruiting

• Conditions: Postherpetic Neuralgia
• Interventions: Drug: esketamine group; Drug: control group

• Registration Number: NCT06896994
• Lead Sponsor: Beijing Tiantan Hospital

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

Study Timeline

• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-20
• Study First Posted: 2025-03-26
• Status Verified: 2025-04
• Study Start: 2025-04-01
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-04-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the esketamine group	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. A total of 0.5 mg/kg of esketamine will be diluted in 50 mL of normal saline. The infusion will commence with an intravenous injection of 10 mg of esketamine over 1 minute, followed by a maintenance dose of 8 mg/h. The infusion rate will be adjusted based on the patients' tolerance levels.
the control group	control group	In the control group, patients will receive pregabaline combined with duloxetine. Pregabaline will be administered at a dose of 50-75 mg, twice daily during the first 3 days of treatment, and increase to 300mg daily after 3-7days, then by an additional 150mg daily every 3-7 days as tolerated, up to a maximum daily dose of 600mg. Meanwhile, duloxetine will be prescribed at an initial daily dose of 30mg, and then gradually increased to 60 mg daily after one week if patients tolerate it well.

Primary Outcome Measures

Name	Time	Method
the mean of daily pain scores	during 1 week	the mean of daily pain scores collected during week 1 of treatment measured using the Numerical Pain Rating Scale (NRS,, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain).

Secondary Outcome Measures

Name	Time	Method
Averaged weekly NRS score	1 week, 2 weeks, 3 weeks, and 1 month after treatment	Averaged weekly NRS score of each participant.Generally, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain
percentages of patients having >50% reductions in 24-hour average pain severity during the first week	during the first week	percentages of patients having \>50% reductions
the 12-item Short-Form Health Survey (SF-12) score	1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment	Quality of life (QoL) assessed by the SF-12 score (range 0-100, with higher scores indicating better health status).
the Pittsburgh Sleep Quality Index (PSQI) score	1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment	Sleep quality measured by PSQI score (range 0-21, with higher scores indicating poorer sleep quality).
the Patient Global Impression of Change scale (PGIC)	1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment	The proportion of patients with a response of "no change", "minimally improved", "much improved" or "very much improved" on PGIC.
The Hospital Anxiety and Depression Scale (HADS)	1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment	It consists of two sub-scales. Each sub-scale consists of 7 items and each item scored from 0 to 3. A higher score indicates more severe anxiety or depression. A score of 11 or above can indicate clinically significant anxiety or depression.
Averaged weekly analgesic consumption	1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment	Averaged weekly consumption per analgesic of each participant
Safety assessments	0 day, 1 day, 3 days, 7 days, 2 weeks,3 weeks, and 1 month after treatment	drug-related complications,such as dizziness, somnolence, gait disturbance, nausea, fatigue, diarrhea, dry mouth, mental symptom, etc

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China