North Chicago, Illinois, September 18, 2026
AbbVie has announced new real-world data for VRAYLAR® (cariprazine) presented at Psych Congress 2026, providing additional evidence on the medicine’s use among adults living with major depressive disorder (MDD) and bipolar I disorder (BP-I) depression. The newly presented findings came from prospective real-world observational studies evaluating patient outcomes in routine clinical practice, including depressive symptoms, functioning, motivation, energy and quality of life. The findings add to the clinical evidence supporting VRAYLAR and highlight the importance of evaluating treatments in patient populations encountered in everyday healthcare settings.
AbbVie Presents Real-World VRAYLAR Evidence
At Psych Congress 2026, AbbVie presented findings from the CReW BP-I study, a prospective observational study evaluating VRAYLAR in adults with bipolar I depression, with or without mixed features. The study included 118 adults, with 99 patients included in the efficacy analysis. After 12 weeks of treatment in routine clinical practice, the mean Montgomery-Åsberg Depression Rating Scale (MADRS) score declined from 32.2 at baseline to 19.9 at Week 12, representing a reported change of -12.92. Functional outcomes measured using the Functional Assessment Short Test (FAST) also improved, with scores decreasing from 43.4 to 30.7.
The study also reported improvements across exploratory measures assessing quality of life, manic symptoms, illness severity and patient-reported depression. AbbVie reported that nausea and dizziness were the most common treatment-emergent adverse events, each occurring in 5.1% of patients in the study. Because CReW BP-I was a single-arm observational study, the findings represent changes observed among treated participants and do not establish comparative effectiveness against another treatment or placebo.
VRAYLAR Data Examines Major Depressive Disorder
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AbbVie also presented interim findings from the ProACt MDD study, an ongoing prospective real-world observational study evaluating adults with MDD who began VRAYLAR as an adjunctive treatment to an antidepressant. The interim analysis included 76 participants. Mean PHQ-9 scores declined from 15.7 at baseline to 7.1 at Week 6, while 76.3% of participants reached minimal or mild depression severity, defined in the study as a PHQ-9 score of 9 or lower.
The study also evaluated outcomes beyond depressive symptoms. Mean FAST scores decreased from 37.4 at baseline to 19.9 at Week 6, while improvements were reported in measures of anhedonia, motivation and energy. The results are particularly relevant to real-world treatment research because they examine patient-centered outcomes that extend beyond symptom scores and address aspects of daily functioning that can be affected by depression.
AbbVie Expands Clinical Evidence for VRAYLAR
In addition to the two prospective real-world studies, AbbVie presented an indirect comparative analysis in MDD, long-term pediatric safety data and patient-preference research examining treatment approaches after an inadequate response to antidepressant therapy. The company said the broader data set is intended to provide additional information about VRAYLAR across different patient populations and treatment circumstances. VRAYLAR (cariprazine) is a once-daily prescription medicine with U.S. approvals covering several indications, including adjunctive treatment of MDD in adults, depressive episodes associated with bipolar I disorder in adults, acute manic or mixed episodes associated with bipolar I disorder in adults and pediatric patients aged 10 years and older, and schizophrenia in adults and pediatric patients aged 13 years and older. The medicine was developed jointly by AbbVie and Gedeon Richter, with AbbVie responsible for commercialization in the United States, Canada and certain other markets.
The latest findings add real-world evidence to the established clinical development program for cariprazine. However, the observational design and interim nature of some findings mean the results should be interpreted within the limitations of the individual studies. Continued research will help further characterize VRAYLAR’s effectiveness, safety and patient-centered outcomes across routine clinical settings. For AbbVie, the Psych Congress 2026 presentations demonstrate the company’s continuing focus on neuroscience and psychiatric medicine, while providing clinicians with additional data from patients treated in real-world settings. The findings contribute to the growing body of evidence surrounding cariprazine and its role in the treatment of depression and bipolar I disorder.
Source: AbbVie press release
