Results
Depression, Anxiety, DSM-5
MAY, RECRUITMENT
Recruitment started on 15 August 2016 and closed in April 2020 owing to COVID-19 restrictions. Follow-up was completed in May 2020 and data were extracted 1 July 2021. In total, 1033 individuals were assessed for eligibility and 184 were randomised. Three individuals withdrew consent for the use of their data, leaving 73 participants in cohort 1 (fixed-dose) and 108 in cohort 2 (flexible-dose), of whom 68 and 106 respectively received at least one allocated dose. Most participants received all eight doses (Supplementary material). Most participants in cohort 2 (30/53 ketamine, 38/53 midazolam) were escalated to the highest dose level (see CONSORT diagram in Supplementary material). Baseline clinical and demographic details of the randomised groups within each cohort are shown in Baseline characteristics for the study sampleC-SSRS, Columbia Suicide Severity Rating Scale; ECT, electroconvulsive therapy; HAM-A, Hamilton Anxiety Rating Scale; MADRS, Montgomery–Åsberg Rating Scale for Depression; mITT, modified intention to treat.Percentages reported are based on the mITT sample, i.e. participants who received at least one treatment.Excludes 3 participants from the original 184 randomised who subsequently withdrew consent for use of their data.Assessed by the Structured Clinical Interview for DSM-5 Research Version.