This unregistered trial (n=61) was a randomised, double-blind, non-inferiority trial of racemic ketamine or esketamine infusions for treatment-resistant depression in adults, which identified clinical predictors for symptom remission and response.
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 randomised, double-blind, active-controlled, non-inferiority trial involving 61 participants diagnosed with major depressive disorder meeting treatment-resistant criteria. Participants were randomly assigned to receive either a single subanesthetic dose of racemic ketamine (0.5 mg/kg) or esketamine (0.25 mg/kg) via intravenous infusion.
Researchers assessed depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS) at 24 hours and 7 days post-infusion. The analysis found that a higher number of previous therapeutic failures and greater baseline illness severity were significant predictors of reduced remission and response rates.