This unregistered trial (n=30) was a double-blind, midazolam-controlled pilot randomised clinical trial of intravenous esketamine for major depressive disorder with fluctuating antidepressant response in adults, which found significantly higher response rates in the esketamine group.
This synthetic trial has been added to our database because a psychedelic paper (about a clinical trial) references this trial, but no (live) registration can be found.
The study was a single-centre, double-blind, pilot randomised clinical trial conducted at Beijing Anding Hospital. It investigated whether a single subanesthetic intravenous dose of esketamine (0.2 mg/kg) could boost the efficacy of ongoing oral antidepressant treatment in patients experiencing fluctuating symptoms of major depressive disorder.
Participants were randomised 1:1 to receive either esketamine or midazolam (0.045 mg/kg) as a control. The primary outcome was the MADRS response rate at two weeks. Results indicated that the esketamine group achieved significantly higher response rates compared to the midazolam group, with no serious adverse events or psychotogenic effects reported.
Participants received a single subanesthetic intravenous dose of esketamine while maintaining their original oral antidepressant regimen.
Administered over 40 minutes via syringe pump; participants maintained ongoing adequate antidepressant treatment (ADT).
Participants received a single intravenous dose of midazolam while maintaining their original oral antidepressant regimen.
Administered over 40 minutes via syringe pump; participants maintained ongoing adequate antidepressant treatment (ADT).