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This post hoc analysis evaluated adjunctive lumateperone 42 mg in 481 adults with major depressive disorder and inadequate antidepressant response; 43% met DSM-5 criteria for anxious distress. At Day 43, lumateperone significantly improved MADRS scores versus placebo in patients with anxious distress (LSMD −6.8; 95% CI −9.00 to −4.51; ES 0.85; P<.0001) and without anxious distress (LSMD −3.5; 95% CI −5.47 to −1.58; ES 0.44; P<.001). In the anxious-distress subgroup, MADRS response was 52% and remission 27%, corresponding to NNTs of 3 and 7, respectively. GAD-7 scores also improved significantly in patients with anxious distress (P<.0001), while the difference was not significant in those without anxious distress (P=.379). CGI-S and other depressive symptom measures also improved significantly.
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This post hoc analysis evaluated adjunctive lumateperone 42 mg in 481 adults with major depressive disorder and inadequate antidepressant response; 43% met DSM-5 criteria for anxious distress. At Day 43, lumateperone significantly improved MADRS scores versus placebo in patients with anxious distress (LSMD −6.8; 95% CI −9.00 to −4.51; ES 0.85; P<.0001) and without anxious distress (LSMD −3.5; 95% CI −5.47 to −1.58; ES 0.44; P<.001). In the anxious-distress subgroup, MADRS response was 52% and remission 27%, corresponding to NNTs of 3 and 7, respectively. GAD-7 scores also improved significantly in patients with anxious distress (P<.0001), while the difference was not significant in those without anxious distress (P=.379). CGI-S and other depressive symptom measures also improved significantly.
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