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Not yet recruiting NCT06968624

Ketamine for Postherpetic Neuralgia With Depression

Phase IV Interventional Depression Disorders Herpetic Neuralgia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intravenous Ketamine Infusions, Intravenous normal saline, Oral Duloxetine 60mg.
Who it may be relevant to
Registry conditions: Depression Disorders, Herpetic Neuralgia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Intravenous Ketamine Infusions
    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.
  • Drug Intravenous normal saline
    The patients received a single intravenous infusion of 50 ml normal saline via a micro-infusion pump over 40 minutes
  • Drug Oral Duloxetine 60mg
    Patients received 60 mg/day of oral duloxetine as maintenance therapy for depression.

Primary outcome measures

  • Hospital Anxiety and Depression Scale - Depression score [Time frame: 2 weeks after intravenous ketamine infusion therapy]
Secondary outcome measures (12)
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • Columbia - Suicide Severity Rating Scale（C-SSRS）score [Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy]
  • Clinician-Administered Dissociative States Scale score [Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy]
  • Heart Rate [Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy]
  • Peripheral capillary oxygen saturation [Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy]
  • Noninvasive blood pressure [Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy]
  • Nausea [Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy]
  • Vomiting [Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06968624 · TJ-IRB202503024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗