AbbVie presented new real-world data on VRAYLAR (cariprazine) at Psych Congress 2026 in New Orleans, including findings from two prospective observational studies involving adults with major depressive disorder (MDD) and bipolar I disorder (BP-I) depression.
The CReW BP-I study found that patients receiving VRAYLAR in routine clinical practice experienced significant improvements in depressive symptoms, daily functioning and quality of life after 12 weeks of treatment. Nausea and dizziness were among the most commonly reported adverse events.
Interim results from the ProACt study, which evaluated VRAYLAR as an adjunctive treatment for adults with MDD, also showed improvements in depressive symptoms. The study additionally reported changes in patient-centred outcomes including functioning, motivation, energy and anhedonia.
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“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.”
Additional research presented at the meeting included an indirect comparison of cariprazine and lumateperone as adjunctive treatments for MDD, long-term safety data involving paediatric patients, and a survey examining patient preferences following an inadequate response to antidepressant treatment.
“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.”
The paediatric study found VRAYLAR was generally well tolerated in the age groups evaluated. However, the use of cariprazine for treating autism spectrum disorder is not FDA-approved.
The findings were presented at Psych Congress 2026, an annual meeting focused on developments in psychiatric care and neuroscience.
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