Esketamine Combined Pregabalin and Duloxetine for Postherpetic Neuralgia

April 24, 2025 updated by: Fang Luo, Beijing Tiantan Hospital

Intravenous Infusion of Esketamine in Combination With Pregabalin and Duloxetine for Postherpetic Neuralgia

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the 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.
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.
Other Names:
  • pregabalin+duloxetine+esketamine
Placebo Comparator: the 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.
Drug: control group
receiving the combination of pregabalin and duloxetine
Other Names:
  • pregabalin+duloxetine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the mean of daily pain scores
Time Frame: 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).
during 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Averaged weekly NRS score
Time Frame: 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
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
percentages of patients having >50% reductions
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
Quality of life (QoL) assessed by the SF-12 score (range 0-100, with higher scores indicating better health status).
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
Sleep quality measured by PSQI score (range 0-21, with higher scores indicating poorer sleep quality).
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 proportion of patients with a response of "no change", "minimally improved", "much improved" or "very much improved" on PGIC.
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
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.
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
Averaged weekly consumption per analgesic of each participant
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
drug-related complications,such as dizziness, somnolence, gait disturbance, nausea, fatigue, diarrhea, dry mouth, mental symptom, etc
0 day, 1 day, 3 days, 7 days, 2 weeks,3 weeks, and 1 month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Collaborators

Beijing Ditan Hospital
The First Hospital of Fangshan District,Beijing
Hengshui People's Hospital
Beijing Xiaotangshan Hospital

Investigators

  • Principal Investigator: Fang Luo, M.D., Beijing Tiantan Hospital

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)

April 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-2024-332-02-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not yet decided

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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