Double-blind, randomised controlled add-on trial (n=128) testing oral S‑ketamine (vs placebo) TID for 6 weeks in patients with treatment-resistant major depressive disorder.
Randomised, double‑blind, parallel‑group add‑on trial comparing oral S‑ketamine versus matched placebo in 128 inpatients and outpatients with treatment‑resistant major depressive disorder (HDRS17 >18), continuing their existing antidepressant medication.
Treatment is administered three times daily for 6 weeks with tapered start and finish. Primary outcome is change in HDRS17 score and response rates; secondary assessments include multiple clinical scales, neuroimaging, pharmacokinetics, biomarkers and health‑economic outcomes.
Oral S-ketamine as add-on to ongoing antidepressant treatment for 6 weeks (tapered start and finish).
Oral S‑ketamine TID for 6 weeks with tapered start and finish; exact mg not specified in registry.
Matched oral placebo given as add-on for 6 weeks.
Matched placebo TID for 6 weeks.