New real-world data presented by AbbVie show that adults with major depressive disorder (MDD) and bipolar I depression had meaningful improvements in depressive symptoms, daily functioning and quality of life while being treated with VRAYLAR (cariprazine).

 

The findings, presented at Psych Congress 2026 in New Orleans, come from two prospective observational studies examining how VRAYLAR performs in routine clinical practice — where patients often have more complex medical and psychiatric histories than those enrolled in controlled clinical trials.

 

"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, 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 prospective CReW BP-I study, 118 adults with bipolar I depression, with or without mixed features, were treated with VRAYLAR in routine practice. The efficacy analysis included 99 patients.

 

After 12 weeks, average Montgomery-Åsberg Depression Rating Scale (MADRS) scores fell from 32.2 at baseline to 19.9, a change of -12.92. Functional Assessment Short Test (FAST) scores also declined, from 43.4 to 30.7, representing a change of -13.11.

 

Exploratory measures of quality of life, manic symptoms, illness severity and patient-reported depression also improved 

 

The most common treatment-emergent adverse events were nausea and dizziness, each reported in 5.1% of patients.

 

Interim findings from ProACt MDD, an ongoing prospective real-world study, showed improvements among adults taking VRAYLAR as an adjunct to an antidepressant.

 

Among 76 participants, mean PHQ-9 scores dropped from 15.7 at baseline to 7.1 at week six. The model-estimated change was -9.29, with a 95% confidence interval of -11.13 to -7.45.

 

By week six, 76.3% of participants had reached minimal or mild depression severity, defined as a PHQ-9 score of 9 or lower.

 

Functioning also improved. Mean FAST scores fell from 37.4 at baseline to 19.9 at week six, with a model-estimated change of -15.86.

 

Significant improvements were also observed in measures of anhedonia, motivation and energy as early as week two, with gains continuing through week six.

 

"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, an author of the ProACt study, & 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."