Categorical Improvement in Depressive Symptom Severity: Results From a Randomized Controlled Trial of Cariprazine for Adjunctive Treatment of MDD

Abstract Background Patients with major depressive disorder (MDD) often do not respond to antidepressant (ADT) monotherapy alone and may require adjunctive treatment provide adequate symptom relief. Cariprazine (CAR) is a dopamine D 3 -preferring /D 2 serotonin 5-HT 1A receptor partial agonist approved treat adults schizophrenia manic, mixed, or episodes of bipolar I disorder. Post hoc analysis data from randomized controlled trial evaluated clinically relevant improvements in severity cariprazine patients MDD inadequate response ADT monotherapy. Methods randomized, double-blind, placebo-controlled (NCT03738215) treated CAR (1.5 mg/d mg/d) + placebo ADT; the primary outcome was change baseline week 6 Montgomery-Åsberg Depression Rating Scale (MADRS) total score. category shifts MADRS (normal <6, mild 7–19, moderate 20–34, severe ≥35). were reported as percentage no worsened severity, 1 improvement, ≥1 ≥2 improvement. Examples categorical symptoms at include (1 improvement) (2 improvement). Results Of 751 intent-to-treat (ITT) population (CAR: 1.5 mg/d=250, 3.0 mg/d=252; placebo=249), 1.5%, 64%, 35%. Fewer compared had mg/d=32%, mg/d=33%; placebo=42%). Approximately 68% demonstrated improvement greater by mg/d=68%, mg/d=67%; placebo=58%). A group also versus mg/d=28%, mg/d=17%; placebo=19%). Conclusions In this post analysis, associated proportion categories ADT. These results suggest that meaningful patients. Funding AbbVie