Real-world effectiveness of cariprazine in major depressive disorder and bipolar I disorder in the United States

Aims: The efficacy of cariprazine for major depressive disorder (MDD) (adjunctive therapy) and bipolar I (BP-I) depression has been demonstrated in clinical trials. This study evaluated the real-world effectiveness of cariprazine in reducing depression severity among patients with moderate-to-severe MDD or BP-I depression. Methods: Medical/pharmacy claims and electronic medical records (EMRs) from specialty providers in the OM1 Real-World Data Cloud were used to identify adults with MDD or BP-I who initiated cariprazine (adjunctively for MDD) (first dispensing = index) and had ≥1 EMR and ≥1 claim during 12-month baseline and ≤12-month follow-up periods. Included patients had a baseline Patient Health Questionnaire (PHQ)-9 total score ≥10, reflecting at least moderate depressive symptoms. Follow-up continued until cariprazine discontinuation, alternate diagnosis (e.g. BP-I [MDD cohort] or MDD [BP-I cohort]), or 12 months post-index. Depression severity was assessed using PHQ-9 total scores that were observed or estimated from clinical notes using a previously validated machine learning algorithm. Analyses included mean change in PHQ-9 score from baseline to 2, 6, and 12 months of follow-up. A sensitivity analysis using only observed PHQ-9 scores was conducted. Results: Of 754 patients at baseline, 396 had MDD (mean PHQ-9 = 16.4) and 358 had BP-I (mean PHQ-9 = 16.9). For patients with MDD, mean reductions in PHQ-9 scores from baseline to 2, 6, and 12 months of adjunctive cariprazine treatment were 3.5 (95% CI: 2.7, 4.4; n = 127), 4.1 (2.9, 5.4; n = 87), and 3.7 (1.6, 5.8; n = 52), respectively. For patients with BP-I, mean reductions from baseline to 2, 6, and 12 months were 5.2 (95% CI: 4.2, 6.2; n = 121), 6.5 (5.2, 7.8; n = 90), and 6.9 (5.2, 8.5; n = 54), respectively. Greater improvements were observed in the sensitivity analysis. Conclusions: This real-world effectiveness study of cariprazine treatment for MDD (adjunctive use) or BP-I demonstrated clinically meaningful and sustained improvement in depression symptoms during short- and long-term follow-up.