AbbVie Highlights New Real-World Data Supporting the Effectiveness of VRAYLAR® (cariprazine) at Psych Congress 2026
AbbVie has presented new real-world data on VRAYLAR® (cariprazine) at Psych Congress 2026 in New Orleans, including results from two prospective observational studies in major depressive disorder (MDD) and bipolar I disorder (BP-I) depression. The findings support that efficacy seen in clinical trials translates into everyday practice, where patients typically present with more complex treatment needs.
AbbVie’s Mudra Kapoor, VP of global medical affairs, said real-world evaluation is essential given how heterogeneous mood disorders are, noting the studies show VRAYLAR “can help patients achieve meaningful improvements in depressive symptoms, functioning and other patient-centered outcomes in routine clinical practice.”
CReW BP-I followed 118 adults with BP-I depression (99 included in the efficacy analysis), including patients with comorbid anxiety, trauma-related, depressive and attention-related disorders. At week 12, mean MADRS scores fell from 32.2 to 19.9 (change −12.92; p<0.0001), and FAST scores fell from 43.4 to 30.7 (change −13.11; p<0.0001). Quality of life, manic symptoms, illness severity and patient-reported depression also improved significantly (p<0.0001 for all). The most common adverse events were nausea and dizziness (5.1% each).
ProACt, an ongoing real-world study of adjunctive VRAYLAR in MDD, reported interim results from 76 participants: mean PHQ-9 scores dropped from 15.7 to 7.1 by week 6 (change −9.29; 95% CI −11.13 to −7.45; p<0.001), with 76.3% reaching minimal/mild severity (PHQ-9 ≤9). FAST scores fell from 37.4 to 19.9 (change −15.86; 95% CI −22.53 to −9.18; p<0.001), and significant gains on the SHAPS and MEI-SF scales emerged by week 2, sustained through week 6.
Study author Andrew J. Cutler (SUNY Upstate Medical University; Neuroscience Education Institute) said the studies provide “additional confidence that meaningful improvements in symptoms, functioning and patient-reported outcomes can be achieved beyond the controlled environment of a trial.”
AbbVie also presented: an indirect comparison of cariprazine versus lumateperone as adjunctive treatment for inadequate antidepressant response in MDD; final results from a long-term open-label pediatric safety study in BP-I, schizophrenia and autism spectrum disorder (VRAYLAR was generally well tolerated across age groups studied, though its use in autism is not FDA-approved); and patient-preference survey data showing most MDD patients preferred augmenting existing antidepressants over switching therapies.
MDD affects roughly one in five US adults over their lifetime, and nearly 11 million US adults live with bipolar disorder, yet many continue to experience symptoms despite treatment.
About VRAYLAR: VRAYLAR (cariprazine) is a once-daily oral medication approved as adjunctive MDD therapy in adults, for acute manic/mixed episodes in BP-I (adults and children 10+), for BP-I depressive episodes in adults, and for schizophrenia in patients 13+. The drug gained expanded pediatric and low-dose (0.5mg/0.75mg) approval in December 2025. Since its 2015 approval, over 150,000 clinicians have treated more than 1.9 million patients with VRAYLAR. In a prescriber survey, 88% would recommend it for adjunctive MDD treatment and 92% for BP-I. VRAYLAR was co-developed by AbbVie and Gedeon Richter, with AbbVie commercialising in the US, Canada and select other markets.
