Clinical TrialDepressive DisordersEsketaminePlaceboNot yet recruiting

Ketamine for Postherpetic Neuralgia With Depression

This randomised, double-blind, placebo-controlled Phase IV trial (n=50) will study the effects of a single low-dose intravenous esketamine (0.2 mg/kg; ~14 mg/70 kg over 40 minutes) combined with oral duloxetine (60 mg/day) on depression in patients with postherpetic neuralgia.

Target Enrollment
50 participants
Study Type
Phase IV interventional
Design
Randomized, double Blind

Detailed Description

Prospective, randomised, double-blind, placebo-controlled parallel Phase IV study (n=50) comparing a single low-dose IV esketamine infusion (0.2 mg/kg, ~14 mg/70 kg) plus daily duloxetine 60 mg with saline plus duloxetine in patients with postherpetic neuralgia and comorbid depression.

Primary outcome is HADS‑D at two weeks post‑infusion; secondary outcomes and safety (AEs/SAEs) assessed at multiple time points with data collected via in-person interviews and telephone follow-up.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Esketamine + Duloxetine

experimental

Single IV esketamine infusion (0.2 mg/kg) added to 50 ml saline over 40 minutes, followed by daily duloxetine 60 mg maintenance.

Interventions

  • Esketamine0.2 mg/kg
    via IV• single dose• 1 doses total

    Added to 50 ml saline; infused over 40 minutes.

  • Compound60 mg
    via Oral• daily

    Duloxetine 60 mg/day maintenance therapy.

Saline + Duloxetine

active comparator

Single IV normal saline infusion (50 ml) over 40 minutes, followed by daily duloxetine 60 mg maintenance.

Interventions

  • Placebo50 ml
    via IV• single dose• 1 doses total

    Normal saline 50 ml infused over 40 minutes.

  • Compound60 mg
    via Oral• daily

    Duloxetine 60 mg/day maintenance therapy.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Diagnosed with herpetic neuralgia, with a disease course exceeding 1 month, and an HADS-D score ≥8 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

  • 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.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment50 participants
  • Timeline
    Start: 2025-06-15
    End: 2026-06-01
  • Compounds
    EsketaminePlacebo
  • Topic
    Depressive Disorders

Locations

China

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