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. 2021 Jul 15;17:2347–2357. doi: 10.2147/NDT.S314874

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© 2021 Diekamp et al.

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MADRS total score: change from baseline to 24 hours post-first dose by benzodiazepine use in ASPIRE studies (LOCF).

Notes: MADRS total score ranges from 0 to 60; a higher score indicates a more severe condition. Negative change in score indicates improvement. Negative difference favors esketamine. The benzodiazepine group contains patients who took benzodiazepines between day –2 and day 2. The difference of LS means (95% CI) in reduction of MADRS total score between benzodiazepine and non-benzodiazepine users was 1.1 (–2.24, 4.45) for patients in the esketamine plus standard-of-care group and 2.3 (–0.96, 5.53) for patients in the placebo plus standard-of-care group.^aOf 229 patients randomized to esketamine + standard-of-care and 227 patients randomized to placebo + standard-of-care, 2 patients in each treatment group were excluded from analyses of efficacy because they did not receive a dose of intranasal study drug. In addition, 3 patients in the esketamine group did not have the necessary data to calculate change in MADRS at day 2. ^bBased on ANCOVA with study number, treatment, analysis center within study number, standard-of-care antidepressant as randomized, benzodiazepine group, and treatment-by-benzodiazepine group as factors, and baseline MADRS total score as a continuous covariate. ^cEsketamine + standard-of-care minus placebo + standard-of-care in each benzodiazepine group.

Abbreviations: ANCOVA, analysis of covariance; CI, confidence interval; LOCF, last observation carried forward; LS, least‑squares; MADRS, Montgomery-Asberg Depression Rating Scale; SE, standard error.