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NCT Number: NCT06896994

Esketamine Combined 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

Fang Luo, M.D.

CONTACT

[email protected]

+86 13611326978

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esketamine group

Drug

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

Control group

Drug

receiving the combination of pregabalin and duloxetine

Other names: pregabalin+duloxetine

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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

  3. 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).

  4. 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).

  5. 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.

  6. 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.

  7. 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

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Luo, M.D.

CONTACT

[email protected]

+86 13611326978

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 26, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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