A randomised controlled trial of oral S-ketamine as add-on medication for patients with treatment-resistant major depressive disorder
This double-blind, placebo-controlled parallel-group Phase III trial (n=128) evaluates oral S-ketamine capsules as add-on treatment over 6 weeks for patients with treatment-resistant major depressive disorder (TRD).
Details
Randomised, double-blind, placebo-controlled Phase III trial testing oral S-ketamine as an adjunct to standard antidepressants in patients with treatment-resistant major depressive disorder, with primary endpoint at week 6.
Secondary assessments include sleep, autobiographical memory, pain, anxiety, anhedonia, suicidal ideation, nicotine dependence, quality of life, health-care utilisation, pharmacokinetics of S-ketamine and norketamine, biomarkers, neuroimaging measures, and pharmacogenetic analyses.
The study is multicentre within the Netherlands (anticipated 4 sites), includes an independent data monitoring committee, and offers an open-label off-label ketamine extension after final follow-up for eligible participants.