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NCT Number: NCT06968624

Ketamine for Postherpetic Neuralgia With Depression

This clinical trial examines the antidepressant efficacy and safety of a single low-dose intravenous esketamine combined with oral duloxetine in patients with postherpetic neuralgia and depression (duration more than 1 month). In this prospective, randomized, double-blind, placebo-controlled parallel study, eligible patients were randomized into two groups: one received esketamine plus duloxetine, and the other got placebo plus duloxetine. Both groups underwent standard pain management and neuro modulation therapy. The primary outcome was the Hospital Anxiety and Depression Scale - Depression( HADS-D)score at 2 weeks post - infusion, with various secondary outcomes assessed over multiple time points. Data were collected through in-person interviews and telephone follow-ups.

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Key information

Conditions

Depression Disorders Behavior Behavioral Symptoms Depression Herpetic Neuralgia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with herpetic neuralgia, with a disease course exceeding 1 month, and an HADS-D score ≥8 (15) upon admission.
  • Diagnosed with depression based on the DSM-V and ICD-11 criteria.
  • Aged between 18 and 65 years old.
  • BMI <30 kg/m².

Exclusion criteria

  • Unable to cooperate with questionnaires.
  • Allergic to ketamine.
  • History of other mental disorders such as anxiety.
  • Severe hypertension and serious dysfunctions of heart, lung, liver, or kidney.

Treatment and study plan

Intravenous Ketamine Infusions

Drug

The patients received a single intravenous infusion of esketamine (0.2 mg/kg), which was added to 50 ml of normal saline and administered via a micro-infusion pump over 40 minutes.

Intravenous normal saline

Drug

The patients received a single intravenous infusion of 50 ml normal saline via a micro-infusion pump over 40 minutes

Oral Duloxetine 60mg

Drug

Patients received 60 mg/day of oral duloxetine as maintenance therapy for depression.

Primary outcomes

  1. Hospital Anxiety and Depression Scale - Depression score

    Time frame: 2 weeks after intravenous ketamine infusion therapy

    This scale includes 7 items, and each item is scored from 0 to 3, so the total possible score ranges from 0 to 21. The cutoff scores usually are 0-7 for normal, 8-10 for mild, 11-14 for moderate, and 15-21 for severe depression.

Secondary outcomes

  1. Montgomery-Åsberg Depression Rating Scale score

    Time frame: One day, one week, two weeks, three weeks, four weeks, five weeks and six weeks after intravenous ketamine infusion therapy

    This scale includes 10 items, each rated from 0 to 6. The total score ranges from 0 to 60. The ranges are usually 0-6 normal, 7-19 mild, 20-34 moderate, and 35-60 severe

  2. Hospital Anxiety and Depression Scale - Anxiety score

    Time frame: One day, one week, two weeks, three weeks, four weeks, five weeks and six weeks after intravenous ketamine infusion therapy

    This scale includes 7 items, and each item is scored from 0 to 3, so the total possible score ranges from 0 to 21. The cutoff scores usually are 0-7 for normal, 8-10 for mild, 11-14 for moderate, and 15-21 for severe anxiety.

  3. McGill pain score

    Time frame: One day, one week, two weeks, three weeks, four weeks, five weeks and six weeks after intravenous ketamine infusion therapy

    The main sections of the original MPQ are the Pain Rating Index (PRI), which includes sensory, affective, evaluative, and miscellaneous descriptors. Each category has words ranked by intensity. Then there's the Present Pain Intensity (PPI) scale, which is a 0-5 rating. Higher scores indicate more severe/intense pain

  4. NRS( Numeric Rating Scale) pain score

    Time frame: One day, one week, two weeks, three weeks, four weeks, five weeks and six weeks after intravenous ketamine infusion therapy

    Rating 0-10; 0: No pain;1-3: Mild pain;4-6: Moderate pain ; 7-10: Severe pain.

  5. Short Form-12 Quality of Life Score

    Time frame: One day, one week, two weeks, three weeks, four weeks, five weeks and six weeks after intravenous ketamine infusion therapy

    The Short Form-12 Health Survey (SF-12) is a widely used, self-administered questionnaire designed to assess health-related quality of life. Range: 0-100 for each component. The more scores, the better quality of life.

  6. Columbia - Suicide Severity Rating Scale（C-SSRS）score

    Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy

    The Columbia-Suicide Severity Rating Scale (C-SSRS) is a validated, clinician-administered tool designed to assess suicidal ideation and behavior.Rated on a 0-5 scale, higher scores mean higher risk of suicide.

  7. Clinician-Administered Dissociative States Scale score

    Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy

    The Clinician-Administered Dissociative States Scale (CADSS) is a structured, clinician-administered tool designed to assess acute dissociative states in clinical and research settings. This scale includes 27 items, each item rated on a 0-4 scale, range: 0-108 .

    0-19: Minimal/no dissociation. 20-39: Mild to moderate dissociation.

    • 40: Severe dissociation (indicative of significant impairment).

  8. Heart Rate

    Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy

    Patients' heart rate.

  9. Peripheral capillary oxygen saturation

    Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy

    One of patients' vital signs.

  10. Noninvasive blood pressure

    Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy

    Patients' noninvasive blood pressure

  11. Nausea

    Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy

    Incidence of nausea after ministration of ketamine

  12. Vomiting

    Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy

    Incidence of vomiting after administration of ketamine

  13. Headache

    Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy

    Incidence of headache after administration of ketamine

  14. Diplopia

    Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy

    Incidence of diplopia after administration of ketamine

  15. Hallucination

    Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy

    Incidence of hallucination after administration of ketamine

Study contacts

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

Shuguang Yang, MD

CONTACT

[email protected]

086-027-63639756

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

"Efficacy and Safety of Single Low-Dose Intravenous Ketamine for Postherpetic Neuralgia With Depression: A Randomized Controlled Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 13, 2025
Registry last updated
Jun 3, 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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