Efficacy and Clinical Relevance of Adjunctive Cariprazine Treatment in Patients with Major Depressive Disorder: Post Hoc Analyses from a Phase III Study.

In patients treated with cariprazine 1.5 mg/d + ADT with an inadequate response to 1 ADT, the LSMD [95% CI] vs placebo was statistically significant (−2.3 [−4.1, −0.6]); however, in patients with inadequate responses to 2 to 3 previous ADTs treated with cariprazine 1.5 mg/d + ADT, the effect of treatment did not reach statistical significance, despite a large LSMD [95% CI] vs placebo (−3.2 [−7.1, 0.8]).

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In patients who had an ADT baseline response level ≥25% to <50%, the difference in MADRS improvement between cariprazine 1.5 mg/d + ADT and placebo + ADT treatment was statistically significant (LS mean difference [LSMD] [95% CI], −2.3 [−4.2, −0.3]) in favor of adjunctive cariprazine, while the 3 mg/d + ADT group had greater improvement compared with placebo + ADT, though the difference failed to reach significance.

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Patients with ≥25% to <50% ADT response at baseline treated with adjunctive cariprazine 3 mg/d also saw reduced depressive symptoms, as did patients with <25% baseline ADT response treated with adjunctive cariprazine, though the difference versus adjunctive placebo failed to reach statistical significance for these comparisons.

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