AbbVie Highlights New Real-World Data Supporting the Effectiveness of VRAYLAR® (cariprazine) at Psych Congress 2026

New data from prospective real-world studies of VRAYLAR showed meaningful improvements in depressive symptoms, functioning and quality of life among adults living with major depressive disorder (MDD) and bipolar I (BP-I) depression These findings provide additional evidence that the benefits observed with VRAYLAR in clinical trials can also be achieved in routine practice, where patients often have more complex treatment needs NORTH CHICAGO, Ill. , Sept. 18, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV ) today presented new VRAYLAR ® (cariprazine) data at Psych Congress 2026 in New Orleans, including results from two prospective real-world observational studies in major depressive disorder (MDD) and bipolar I disorder (BP-I). The findings reinforce that the efficacy established in clinical trials translates to effectiveness in the broader, more clinically complex patient populations healthcare providers treat every day. "Because mood disorders are highly heterogeneous, it is critical to evaluate treatments in real-world settings where care is delivered every day," said Mudra Kapoor, M.D., vice president, global medical affairs, AbbVie. "These prospective studies provide additional evidence that VRAYLAR can help patients achieve meaningful improvements in depressive symptoms, functioning and other patient-centered outcomes in routine clinical practice." In the real-world BP-I depression study, CReW BP-I, patients treated with VRAYLAR experienced significant improvements in depressive symptoms as well as outcomes that affect daily life, including functioning and quality of life, after 12 weeks of treatment in routine clinical practice; the most common adverse events were nausea and dizziness. In ProACt, a real-world study of adjunctive VRAYLAR in MDD, interim findings showed improvements not only in depressive symptoms, but also in outcomes that affect day-to-day life and matter most to patients, including functioning, motivation, energy and anhedonia. In addition to these real-world studies, AbbVie also presented an indirect comparative analysis in MDD, long-term pediatric safety data, and patient preference research evaluating treatment approaches following inadequate antidepressant response. "For clinicians, one of the most important questions is whether the benefits demonstrated in clinical trials hold up in the real world, where patients have unique needs, experiences and treatment journeys," said Andrew J. Cutler, M.D., an author of the ProACt study, Clinical Professor of Psychiatry at SUNY Upstate Medical University and Chief Medical Officer of the Neuroscience Education Institute. "These studies reinforce what has been established in VRAYLAR clinical trials and provide additional confidence that meaningful improvements in symptoms, functioning and patient-reported outcomes can be achieved beyond the controlled environment of a trial. That kind of real-world validation is valuable when making individualized treatment decisions in everyday clinical practice." MDD and BP-I can profoundly affect every aspect of a person's life and often require long-term, comprehensive care. Approximately one in five U.S. adults will experience MDD during their lifetime, 1 and nearly 11 million adults are living with bipolar disorder, 2 yet many continue to experience ongoing symptoms despite available treatments—highlighting persistent unmet treatment needs. Additional Presentations at Psych Congress 2026: An anchored matching-adjusted indirect comparison evaluating the efficacy and safety of cariprazine and lumateperone as adjunctive treatment for inadequate antidepressant response in adults with MDD. Final results from a long-term, open-label study evaluating the safety and tolerability of VRAYLAR among pediatric patients with BP-I disorder, schizophrenia or autism spectrum disorder, which showed VRAYLAR was generally well tolerated in the age groups studied. The use of cariprazine in the treatment of autism is not FDA-approved. Results from a...