Efficacy of Cariprazine as Adjunctive Treatment of Major Depressive Disorder in Patients with Anxiety at Baseline: A Post Hoc Analysis of a Randomized Controlled Trial

Abstract: Background: The efficacy of adjunctive cariprazine treatment on depressive symptoms was evaluated in patients with major depressive disorder (MDD) and inadequate response to antidepressant treatment (ADT), stratified by baseline anxiety level. Methods: Post hoc analysis evaluated data from a randomized, double-blind, placebo-controlled MDD trial (NCT03738215) in patients treated with cariprazine (1.5 mg/d or 3 mg/d) + ADT versus placebo + ADT. Change from baseline to week 6 in Montgomery–Åsberg Depression Rating Scale (MADRS) total score was analyzed in subgroups defined by baseline Hamilton Anxiety Rating Scale scores: ≤14=mild, >14=moderate or severe. Least squares mean (LSM) change and differences versus placebo (LSMDs) with 95% confidence intervals (95% CIs) were estimated using MMRM. Results: Of the 751 patients in the intent-to-treat population (cariprazine +ADT: 1.5 mg/d =250, 3.0 mg/d=252; placebo +ADT=249), 17.4% had at least mild and 82.6% had at least moderate anxiety at baseline. In the higher anxiety population, LSM reduction in MADRS total score at week 6 was greater for cariprazine 1.5 mg/d + ADT (-14.7) and 3 mg/d + ADT (-13.2) versus placebo + ADT (-11.9; LSMD: 1.5 mg/d=-2.84 [-4.67, -1.02]; 3.0 mg/d=-1.27 [-3.12, 0.57]). In the lower anxiety population, LSM reduction in MADRS total score was greatest with 3 mg/d + ADT (-12.5; LSMD=-2.65 [-6.10, 0.81]) relative to 1.5 mg/d + ADT (-10.6; LSMD=-0.67 [-4.30, 2.96]) or placebo (-9.9). Conclusions: In this post hoc analysis, adjunctive cariprazine treatment was associated with reductions in depressive symptoms in patients with MDD and varied severities of anxiety at baseline.Short Description: Data from a randomized controlled trial evaluating cariprazine plus ADT versus placebo plus ADT in patients with MDD and higher or lower levels of baseline anxiety was analyzed post hoc. Treatment with cariprazine was associated with improvement in depressive symptoms at week 6 in patients with baseline anxiety. These results suggest that cariprazine as adjunctive therapy may improve depressive symptoms in patients with MDD and baseline anxiety.Name of Sponsoring Organization(s): AbbVie