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.
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.
Single IV esketamine infusion (0.2 mg/kg) added to 50 ml saline over 40 minutes, followed by daily duloxetine 60 mg maintenance.
Added to 50 ml saline; infused over 40 minutes.
Duloxetine 60 mg/day maintenance therapy.
Single IV normal saline infusion (50 ml) over 40 minutes, followed by daily duloxetine 60 mg maintenance.
Normal saline 50 ml infused over 40 minutes.
Duloxetine 60 mg/day maintenance therapy.