Actively Recruiting
Intravenous Infusion of Esketamine with Pregabalin and Duloxetine to Relieve Postherpetic Neuralgia Pain
Led by Beijing Tiantan Hospital · Updated on 2025-04-27
150
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
B
Beijing Tiantan Hospital
Lead Sponsor
B
Beijing Xiaotangshan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects and safety of combining esketamine with pregabalin and duloxetine to relieve pain in patients with postherpetic neuralgia (PHN) who have persistent pain after healing from herpes zoster. The study aims to find a rapid, effective, and safe treatment option for patients with PHN who have not responded well to pregabalin alone. This is an interventional trial sponsored by Beijing Tiantan Hospital. Participants are divided into two groups. One group receives pregabalin and duloxetine along with a single intravenous infusion of esketamine, starting with a 10 mg injection followed by a maintenance infusion adjusted by tolerance. The other group receives pregabalin and duloxetine alone with a dose escalation of pregabalin from 50-75 mg twice daily to a maximum of 600 mg daily, and duloxetine increased from 30 mg to 60 mg daily over time. The treatment period is one week. During the study, participants’ daily pain scores are recorded, and other assessments include sleep quality, anxiety and depression levels, overall impression of change, and analgesic consumption at multiple time points up to one month after treatment. Safety is closely monitored through regular evaluations. The total participation duration includes the one-week treatment and follow-up assessments extending to one month.
CONDITIONS
Brief Title
Esketamine Combined Pregabalin and Duloxetine for Postherpetic Neuralgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Pain lasting more than 3 months after healing of a herpes zoster skin rash
- Average pain score of at least 4 on a Numeric Rating Scale (NRS)
- Failed to respond to or tolerate effective dose of pregabalin alone
You will not qualify if you...
- Obstructive sleep apnea syndrome
- Receiving interventional treatments
- History of systemic immune diseases, organ transplantation, or cancers
- Severe heart, lung, liver, or kidney dysfunction
- History of schizophrenia, epilepsy, myasthenia gravis, or delirium
- Current use of monoamine oxidase inhibitors (MAOIs)
- Untreated angle-closure glaucoma
- Increased intracranial pressure
- Hyperthyroidism or phaeochromocytoma
- History of drug abuse
- Contraindications to esketamine, pregabalin, or duloxetine
- Communication difficulties
- Women who are pregnant, breastfeeding, or planning pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 month
Participants receive treatment with pregabalin and duloxetine, with some also receiving a single intravenous infusion of esketamine to relieve postherpetic neuralgia pain.
Multiple assessment visits during treatment including 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
Research Team
F
Fang Luo, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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