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The KARMA-Dep 2 randomized clinical trial evaluated whether serial intravenous ketamine infusions improved depressive symptoms more effectively than midazolam when added to usual inpatient psychiatric care in adults hospitalized with moderate-to-severe unipolar or bipolar depressive episodes. A total of 65 participants were randomized to receive up to eight twice-weekly infusions of ketamine 0.5 mg/kg or midazolam 0.045 mg/kg, with 62 participants included in the final analysis. The primary endpoint was change in observer-rated MADRS score from baseline to the end of treatment. The adjusted mean difference in end-of-treatment MADRS scores favoured ketamine by −3.16 points, but the difference was not statistically significant (95% CI, −8.54 to 2.22; P=0.25; Cohen d=−0.29). Similarly, the between-group difference in self-reported Quick Inventory of Depressive Symptomatology scores was −0.002 points (95% CI, −2.71 to 2.71; P>0.99; Cohen d=−0.0004). No significant between-group differences were observed in secondary efficacy outcomes, cognition, cost-effectiveness, or quality of life. The trial was relatively small, and most participants and raters correctly guessed treatment allocation, raising concerns about the effectiveness of blinding. Serial ketamine infusions were not shown to be superior to an active psychoactive comparator when added to usual inpatient care, highlighting the need for adequately powered trials with robust blinding and longer-term follow-up
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The KARMA-Dep 2 randomized clinical trial evaluated whether serial intravenous ketamine infusions improved depressive symptoms more effectively than midazolam when added to usual inpatient psychiatric care in adults hospitalized with moderate-to-severe unipolar or bipolar depressive episodes. A total of 65 participants were randomized to receive up to eight twice-weekly infusions of ketamine 0.5 mg/kg or midazolam 0.045 mg/kg, with 62 participants included in the final analysis. The primary endpoint was change in observer-rated MADRS score from baseline to the end of treatment. The adjusted mean difference in end-of-treatment MADRS scores favoured ketamine by −3.16 points, but the difference was not statistically significant (95% CI, −8.54 to 2.22; P=0.25; Cohen d=−0.29). Similarly, the between-group difference in self-reported Quick Inventory of Depressive Symptomatology scores was −0.002 points (95% CI, −2.71 to 2.71; P>0.99; Cohen d=−0.0004). No significant between-group differences were observed in secondary efficacy outcomes, cognition, cost-effectiveness, or quality of life. The trial was relatively small, and most participants and raters correctly guessed treatment allocation, raising concerns about the effectiveness of blinding. Serial ketamine infusions were not shown to be superior to an active psychoactive comparator when added to usual inpatient care, highlighting the need for adequately powered trials with robust blinding and longer-term follow-up
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