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We aimed to evaluate the efficacy and safety of intravenous ketamine in Japanese patients with TRD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this double\u2010blind randomized placebo\u2010controlled trial, 34 Japanese patients with TRD were randomized to receive either intravenous ketamine (0.5\u2009mg\/kg) or placebo, administered over 40\u2009min, twice a week, for 2\u2009weeks. The primary outcome was the change in the Montgomery \u00c5sberg Depression Rating Scale (MADRS) total score from baseline to post\u2010treatment. Secondary outcomes included changes in other depressive symptomatology scores and remission, response, and partial response rates. We also examined the association between baseline clinical demographic characteristics and changes in the MADRS total score.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Intention\u2010to\u2010treat analysis indicated no significant difference in the decrease in MADRS total score between the groups (\u22128.1\u2009\u00b1\u200910.0 vs \u22122.5\u2009\u00b1\u20095.2, <jats:italic>t<\/jats:italic>[32]\u2009=\u20092.02, <jats:italic>P<\/jats:italic>\u2009=\u20090.052), whereas per\u2010protocol analysis showed a significant reduction in the ketamine group compared to the placebo group (\u22129.1\u2009\u00b1\u200910.2 vs \u22122.7\u2009\u00b1\u20095.3, <jats:italic>t<\/jats:italic>[29]\u2009=\u20092.22, <jats:italic>P<\/jats:italic>\u2009=\u20090.034). No significant group differences were observed in other outcomes. Adverse events were more frequent in the ketamine group than in the placebo group, and no serious adverse events were reported. A higher baseline MADRS total score and body mass index were associated with a greater reduction in the MADRS total score.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Intravenous ketamine outperformed placebo in Japanese patients with TRD who completed the study, suggesting that ketamine could alleviate depressive symptoms of TRD across diverse ethnic populations.<\/jats:p><\/jats:sec>","DOI":"10.1111\/pcn.13734","type":"journal-article","created":{"date-parts":[[2024,8,30]],"date-time":"2024-08-30T07:14:59Z","timestamp":1725002099000},"page":"765-775","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Efficacy and safety of intravenous ketamine treatment in Japanese patients with treatment\u2010resistant depression: A double\u2010blind, randomized, placebo\u2010controlled 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