Primary outcome
Depression, anxiety
SECONDARY, REMISSION
For the primary outcome (remission defined as MADRS score ≤10), there was no statistically significant difference in remission rates between treatments for cohort 1 (fixed-dose) (OR = 1.34, 95% CI 0.22–8.21, Change from baseline in Montgomery–Åsberg Rating Scale for Depression (MADRS) scores across the randomised controlled trial phase for the two cohorts.The odds favouring ketamine in cohort 2 were higher than the odds in cohort 1 (OR = 12.96, 95% CI 1.10–152.54, Primary and key secondary efficacy outcomes at the trial endRCT, randomised controlled trial; MADRS, Montgomery–Åsberg Rating Scale for Depression; mITT, modified intention to treat, i.e. participants who received at least one treatment.For End RCT, Odds ratio (OR) from multiply imputed data-sets, adjusted for covariates. An OR > 1 favours ketamine.The Supplementary material gives pre-specified sensitivity, heterogeneity and subgroup analyses. The key findings of note were a signal of greater treatment effects (after ketamine treatment compared with midazolam) in those with higher baseline anxiety scores, those with a greater number of prior failed antidepressant treatments and those taking a concomitant antipsychotic.