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This phase 4 randomized clinical trial evaluated intranasal esketamine monotherapy in 378 adults with treatment-resistant depression who had demonstrated inadequate response to at least two antidepressants during the current depressive episode. Participants received esketamine 56 mg (n=86), esketamine 84 mg (n=95), or placebo (n=197) twice weekly for four weeks, with change from baseline in the Montgomery–Åsberg Depression Rating Scale (MADRS) score at day 28 as the primary endpoint. Mean MADRS scores decreased by 12.7 points (SD, 11.82) with esketamine 56 mg and 13.9 points (SD, 11.89) with esketamine 84 mg; the least-squares mean differences versus placebo were −5.1 points (SE, 1.42; 95% CI, −7.91 to −2.33; P<0.001) and −6.8 points (SE, 1.38; 95% CI, −9.48 to −4.07; P<0.001), respectively, with effect sizes of 0.48 and 0.63. Significant improvement was also observed 24 hours after the first dose, with between-group differences of −3.8 points (95% CI, −6.29 to −1.22; P=0.004) for 56 mg and −3.4 points (95% CI, −5.89 to −1.00; P=0.006) for 84 mg. Treatment-emergent adverse events included nausea (24.8%), dissociation (24.3%), dizziness (21.7%), and headache (19.0%). Overall, both esketamine doses significantly improved depressive symptoms compared with placebo, with benefits emerging within 24 hours and persisting throughout the four-week treatment period. These findings support the potential of intranasal esketamine monotherapy for adults with treatment-resistant depression, although its short-term efficacy must be considered alongside its tolerability profile and the need for further evidence on long-term effectiveness and safety.
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This phase 4 randomized clinical trial evaluated intranasal esketamine monotherapy in 378 adults with treatment-resistant depression who had demonstrated inadequate response to at least two antidepressants during the current depressive episode. Participants received esketamine 56 mg (n=86), esketamine 84 mg (n=95), or placebo (n=197) twice weekly for four weeks, with change from baseline in the Montgomery–Åsberg Depression Rating Scale (MADRS) score at day 28 as the primary endpoint. Mean MADRS scores decreased by 12.7 points (SD, 11.82) with esketamine 56 mg and 13.9 points (SD, 11.89) with esketamine 84 mg; the least-squares mean differences versus placebo were −5.1 points (SE, 1.42; 95% CI, −7.91 to −2.33; P<0.001) and −6.8 points (SE, 1.38; 95% CI, −9.48 to −4.07; P<0.001), respectively, with effect sizes of 0.48 and 0.63. Significant improvement was also observed 24 hours after the first dose, with between-group differences of −3.8 points (95% CI, −6.29 to −1.22; P=0.004) for 56 mg and −3.4 points (95% CI, −5.89 to −1.00; P=0.006) for 84 mg. Treatment-emergent adverse events included nausea (24.8%), dissociation (24.3%), dizziness (21.7%), and headache (19.0%). Overall, both esketamine doses significantly improved depressive symptoms compared with placebo, with benefits emerging within 24 hours and persisting throughout the four-week treatment period. These findings support the potential of intranasal esketamine monotherapy for adults with treatment-resistant depression, although its short-term efficacy must be considered alongside its tolerability profile and the need for further evidence on long-term effectiveness and safety.
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