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The Ket-BD randomized clinical trial evaluated adjunctive intravenous ketamine in adults with treatment-resistant bipolar I or II depression who had failed at least 2 evidence-based pharmacotherapies. Sixty-eight participants were randomized 1:1 to four flexibly dosed ketamine infusions (0.5–0.75 mg/kg) or midazolam over 2 weeks, with 63 included in the final efficacy analysis. At day 14, mean MADRS scores were significantly lower with ketamine, with a between-group difference of −7.3 points (95% CI, −12.0 to −2.5; P=.003; Cohen d=0.7). No cases of mania, hypomania, psychosis, or suicide attempts occurred in either group; one participant in each group developed mixed features.
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The Ket-BD randomized clinical trial evaluated adjunctive intravenous ketamine in adults with treatment-resistant bipolar I or II depression who had failed at least 2 evidence-based pharmacotherapies. Sixty-eight participants were randomized 1:1 to four flexibly dosed ketamine infusions (0.5–0.75 mg/kg) or midazolam over 2 weeks, with 63 included in the final efficacy analysis. At day 14, mean MADRS scores were significantly lower with ketamine, with a between-group difference of −7.3 points (95% CI, −12.0 to −2.5; P=.003; Cohen d=0.7). No cases of mania, hypomania, psychosis, or suicide attempts occurred in either group; one participant in each group developed mixed features.
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