This randomised, double-blind, placebo-controlled Phase IV trial (n=50) will study the effects of a single low-dose intravenous infusion of esketamine (14mg/70kg over 40 minutes) combined with oral duloxetine (60mg/day) on depression in patients with postherpetic neuralgia (nerve pain that continues after a shingles infection).
Conducted by Huazhong University of Science and Technology in China, this interventional study aims to evaluate the antidepressant efficacy and safety of esketamine when added to standard treatment in individuals suffering from both chronic nerve pain and depression (lasting longer than one month).
Participants, aged 18 to 65, will be randomly assigned to receive either esketamine or placebo alongside duloxetine. The primary outcome is change in depression levels measured by the Hospital Anxiety and Depression Scale – Depression subscale (HADS-D) two weeks post-infusion. Secondary outcomes include various psychological, pain, and quality of life measures over a six-week follow-up period. The trial also monitors for side effects such as nausea, headache, dissociation, and hallucinations. Data will be collected via interviews and follow-ups.
Trial Details
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.Trial Number NCT06968624