This unregistered trial (n=51) was a pooled analysis of two controlled ketamine infusion studies for major depressive disorder in inpatients, which found that heart rate and heart rate variability could serve as predictive biomarkers for treatment 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 pooled data from two controlled trials conducted between 2010 and 2015 involving 51 inpatients with major depressive disorder. Participants received either a single intravenous infusion of racemic ketamine at a dose of 0.54 mg/kg or a saline placebo.
Researchers investigated the predictive and discriminative power of autonomic nervous system markers, specifically heart rate and heart rate variability, alongside EEG biomarkers. The analysis demonstrated that higher heart rates during the investigation period were associated with clinical response, suggesting these physiological measures may help optimise treatment selection for depression.
Single intravenous dose of racemic ketamine hydrochloride administered via infusion pump.
Loading dose of 0.27 mg/kg for the first 10 min, followed by an infusion of 0.27 mg/kg within 20 min. Total dose 0.54 mg/kg within 30 min.
Equal amount of saline (sodium chloride 0.9%) solution administered via infusion pump.
Saline (0.9% NaCl) administered over the same time period as ketamine.