New Real-World Data Supporting Cariprazine for MDD and Bipolar I Depression

AbbVie today presented new cariprazine (Vraylar) data, including results from 2 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.¹

Vraylar is a once-daily prescription medication approved as an add-on therapy for MDD in adults who are currently taking an antidepressant but still have unresolved depression symptoms, the acute treatment of manic or mixed episodes associated with BP-I in adults and pediatric patients 10 years of age and older, the treatment of depressive episodes associated with BP-I (bipolar depression) in adults, and for the treatment of schizophrenia in patients 13 years of age and older.

“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, MD, the vice president of global medical affairs at 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 CReW BP-I Study

The CReW BP-I study was prospective, observational, real-world study that evaluated Vraylar in 118 adult participants with BP-I depression, with or without mixed features. The efficacy analysis included 99 participants. Participants with a history of psychiatric conditions—including anxiety, trauma-related, depressive, and attention-related disorders—were included, ensuring the participant population was reflective of the patients clinicians are seeing in everyday practice. The study was a single-arm study, and investigators assessed outcomes based on changes from baseline.²

Participants 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. At week 12, mean Montgomery-Åsberg Depression Rating Scale (MADRS) scores decreased from a baseline of 32.2 to 19.9 at week 12 (change, -12.92; P<0.0001), while Functional Assessment Short Test (FAST) scores decreased from 43.4 at baseline to 30.7 at week 12 (change, -13.11; P<0.0001). Exploratory measures of quality of life, manic symptoms, illness severity and patient-reported depression also improved (P<0.0001 for all measures). Nausea and dizziness were the most common treatment-emergent adverse events (5.1% each).

The ProACt MDD Study

ProACt MDD is an ongoing, prospective, real-world, observational study evaluating adults with MDD initiating Vraylar as an adjunctive therapy to an antidepressant. Participants with a history of psychiatric conditions including anxiety disorders, trauma, sleep disorders, and stress were included. The study is a single-arm pre-post longitudinal patient-survey study and outcomes were assessed based on changes from baseline.³

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. The interim analysis of 76 participants showed that mean PHQ-9 scores decreased from 15.7 at baseline to 7.1 at week 6 (model-estimated change, -9.29; 95% CI, -11.13 to -7.45; P<0.001). Approximately 76.3% of participants reached minimal/mild depression severity, defined as a PHQ-9 score ≤9, by week 6. Mean FAST scores decreased from 37.4 at baseline to 19.9 at week 6 (model-estimated change -15.86; 95% CI, -22.53 to -9.18; P<0.001). Significant improvements were also observed on the Snaith-Hamilton Pleasure Scale (SHAPS) and Motivation and Energy Inventory-Short Form (MEI-SF) by week 2 and continued through week 6.

“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, MD, an author of the ProACt study, a 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.”

References

1. AbbVie Highlights New Real-World Data Supporting the Effectiveness of VRAYLAR® (cariprazine) at Psych Congress 2026. News release. September 18, 2026. Accessed September 18, 2026. https://news.abbvie.com/2026-09-18-AbbVie-Highlights-New-Real-World-Data-Supporting-the-Effectiveness-of-VRAYLAR-R-cariprazine-at-Psych-Congress-2026

2. Singh MK, McIntyre RS, Selvaraj V, et al. Cariprazine improves depressive symptoms, functioning, and quality of life in bipolar I depression: 12-week real-world results from the prospective observational CReW BP-I study. Poster presented at: Psych Congress 2026; September 15-19, 2026; New Orleans, LA. Accessed September 18, 2026.

3. McIntyre RS, Cutler AJ, Albright B, et al. Improvement in patient-reported outcomes following adjunctive cariprazine initiation in adults with major depressive disorder: Interim results from a real-world study. Poster presented at: Psych Congress 2026; September 15-19, 2026; New Orleans, LA. Accessed September 18, 2026.