Ketamine for Postherpetic Neuralgia With Depression

Phase 4Not Yet RecruitingNCT06968624

Huazhong University of Science and Technology50 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Depression Disorders Herpetic Neuralgia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Hospital Anxiety and Depression Scale - Depression score

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.

Time frame: 2 weeks after intravenous ketamine infusion therapy

Secondary Outcomes

Montgomery-Åsberg Depression Rating Scale score

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

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

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

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

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

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

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.

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

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.