AbbVie Presents New VRAYLAR Data Highlighting Real-World Outcomes in Depression and Bipolar I Disorder
AbbVie (NYSE: ABBV) has presented new data for VRAYLAR® (cariprazine) at Psych Congress 2026 in New Orleans, Louisiana, highlighting findings from prospective real-world observational studies in major depressive disorder (MDD) and bipolar I disorder (BP-I). The presentations provide additional insight into how cariprazine performs in routine clinical practice, where patients often have more varied symptoms, treatment histories and healthcare needs than those represented in controlled clinical trials.
The new findings include results from the CReW BP-I study evaluating VRAYLAR in people with bipolar I depression and interim findings from ProACt, which is examining adjunctive VRAYLAR treatment in adults with MDD. According to AbbVie, both studies showed improvements in depressive symptoms as well as measures that extend beyond symptom reduction, including functioning and other patient-centered outcomes.
The company said the findings add to the evidence generated through randomized clinical trials and support the importance of evaluating psychiatric treatments in real-world settings.
“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.”
Real-World Study Examines VRAYLAR in Bipolar I Depression
One of the featured studies at Psych Congress 2026 was CReW BP-I, a prospective real-world observational study examining the effects of VRAYLAR in patients with bipolar I depression.
Bipolar I disorder is characterized by episodes of mania as well as periods of depression, and depressive symptoms can have a substantial effect on everyday functioning and quality of life. Although treatment options are available, some patients continue to experience significant depressive symptoms, creating an ongoing need for therapies that can address both symptoms and their broader impact.
In the CReW BP-I study, patients treated with VRAYLAR experienced significant improvements in depressive symptoms following 12 weeks of treatment in routine clinical practice. The improvements were also observed in outcomes related to daily life, including functioning and quality of life.
The findings are notable because real-world patients may differ from the highly selected populations typically enrolled in randomized clinical trials. Factors such as comorbidities, previous treatment experiences, treatment adherence and individual symptom patterns can influence outcomes in everyday psychiatric care.
AbbVie reported that the most common adverse events observed in the CReW BP-I study were nausea and dizziness. The safety findings provide additional information about the tolerability of VRAYLAR when used in routine clinical practice.
ProACt Evaluates Adjunctive Treatment in Major Depressive Disorder
AbbVie also presented interim results from ProACt, a prospective real-world study evaluating VRAYLAR as an adjunctive treatment for adults with MDD.
Patients with MDD may continue to experience depressive symptoms despite treatment with an antidepressant. In such cases, clinicians may consider augmentation strategies rather than switching completely to another antidepressant.
The interim ProACt findings showed improvements in depressive symptoms among patients receiving adjunctive VRAYLAR. Importantly, the study also examined outcomes that can directly influence patients’ everyday experiences.
According to AbbVie, improvements were observed in areas including functioning, motivation, energy and anhedonia. Anhedonia, or reduced ability to experience pleasure or interest, is a common and potentially persistent component of depression and can affect social interactions, work, relationships and other aspects of daily life.
By examining these patient-centered outcomes alongside overall depressive symptoms, the ProACt study is intended to provide a broader picture of treatment effectiveness outside the controlled environment of a clinical trial.
The interim nature of the findings means additional data may further characterize the treatment’s effects as the study progresses.
Real-World Evidence Adds to Clinical Trial Data
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, emphasized the importance of understanding whether clinical trial findings translate into everyday care.
For clinicians, Cutler said, a key question is whether treatment benefits observed in clinical trials remain evident among patients with different needs, experiences and treatment histories.
He said the real-world studies presented at Psych Congress reinforce findings previously established through VRAYLAR clinical trials and provide additional evidence that improvements can be achieved in symptoms, functioning and patient-reported outcomes in routine practice.
Real-world observational studies can complement randomized controlled trials by providing information about how treatments are used and experienced in broader clinical populations. While such studies have methodological limitations compared with randomized trials, they can offer additional context regarding treatment effectiveness, tolerability and patient experience.
Additional MDD Comparative Analysis
Beyond the prospective real-world studies, AbbVie presented an anchored matching-adjusted indirect comparison evaluating the efficacy and safety of cariprazine and lumateperone as adjunctive treatments for adults with MDD who have had an inadequate response to antidepressant treatment.
Indirect treatment comparisons can be used to examine outcomes across separate clinical trial programmes when direct head-to-head trials are unavailable. Matching-adjusted approaches seek to account for differences between study populations so that treatment outcomes can be compared using adjusted analyses.
The presentation adds another component to AbbVie’s broader evidence package around adjunctive treatment strategies for patients whose depressive symptoms persist despite antidepressant therapy.
The analysis focused on both efficacy and safety, providing information relevant to the evaluation of cariprazine and lumateperone in the adjunctive MDD treatment setting.
Long-Term Pediatric Safety Data Presented
AbbVie also shared final results from a long-term, open-label study assessing the safety and tolerability of VRAYLAR among pediatric patients with bipolar I disorder, schizophrenia or autism spectrum disorder.
The study showed that VRAYLAR was generally well tolerated among the pediatric age groups evaluated, according to AbbVie.
Long-term safety data are particularly important when evaluating psychiatric medicines in younger populations because treatment decisions can involve extended periods of use and require careful consideration of tolerability and patient-specific factors.
AbbVie noted an important regulatory distinction concerning the autism spectrum disorder population: the use of cariprazine for the treatment of autism is not FDA-approved.
The presentation therefore provides safety information from the study population but should not be interpreted as establishing an FDA-approved indication for cariprazine in autism.
Patient Preferences Following Inadequate Antidepressant Response
Another presentation at Psych Congress 2026 examined treatment preferences among people with MDD who experienced an inadequate response to an antidepressant.
According to results from an MDD patient survey, most participants preferred augmenting their existing antidepressant treatment rather than switching to another therapy following an inadequate response.
The findings highlight the importance of considering patient preferences when determining the next step in depression treatment. For some patients, maintaining an existing antidepressant while adding another treatment may be preferable to stopping the current medicine and beginning a new treatment regimen.
The survey findings also underscore the potential role of adjunctive treatment options for patients who continue to experience symptoms despite antidepressant therapy.
Persistent Treatment Needs in MDD and Bipolar Disorder
MDD and BP-I can affect multiple dimensions of health and daily life, including emotional well-being, physical functioning, relationships, work and social participation. Both conditions may require long-term management and individualized treatment strategies.
AbbVie cited estimates indicating that approximately one in five U.S. adults will experience MDD during their lifetime. The company also noted that nearly 11 million U.S. adults are living with bipolar disorder.
Despite the availability of established treatments, some patients continue to experience persistent symptoms or inadequate responses to therapy. These challenges contribute to ongoing interest in treatment approaches that can address depressive symptoms while also improving functioning and other outcomes that patients consider important.
The real-world findings presented at Psych Congress 2026 are therefore intended to complement the existing clinical evidence for VRAYLAR by examining treatment outcomes in routine practice.
Broader Evidence Program for VRAYLAR
The collection of presentations at Psych Congress 2026 covers several dimensions of cariprazine research, including effectiveness in routine clinical practice, comparative evidence, long-term pediatric safety and patient treatment preferences.
The CReW BP-I findings provide real-world evidence in bipolar I depression, while ProACt focuses on adjunctive use in MDD. Together, the studies examine both symptom-related and broader patient-centered outcomes.
The additional comparative analysis addresses the relative evidence for adjunctive therapies in adults with MDD and inadequate antidepressant response. Meanwhile, the pediatric study contributes longer-term safety and tolerability information in younger patients across the studied psychiatric populations.
The patient survey adds another perspective by examining what people with MDD prefer after an initial antidepressant treatment does not provide an adequate response.
Taken together, these presentations demonstrate the range of evidence being generated around VRAYLAR across different patient groups and clinical questions. The findings do not replace evidence from randomized controlled trials, but they provide additional information about treatment experiences and outcomes in settings that more closely reflect routine psychiatric care.
For AbbVie, the data presented at Psych Congress 2026 further expand the clinical evidence surrounding VRAYLAR and highlight the company’s focus on outcomes that extend beyond symptom scores alone. As psychiatric care increasingly emphasizes individualized treatment decisions, information on functioning, quality of life, motivation, energy, patient preferences and long-term tolerability can help provide a more comprehensive understanding of treatment experiences.
About VRAYLAR®3
VRAYLAR® (cariprazine) 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.
VRAYLAR received FDA approval for certain pediatric populations and low doses (0.5 mg and 0.75 mg) in December of 2025, demonstrating continued innovation more than 10 years in. Since its approval in 2015, more than 150,000 clinicians have used VRAYLAR to treat more than 1.9 million patients across its indications.4 In a survey of healthcare professionals treating MDD and BP-I, 88% of VRAYLAR prescribers would recommend it as an adjunctive MDD treatment, while 92% would recommend it for BP-I.5
VRAYLAR was developed jointly by AbbVie and Gedeon Richter Plc, with AbbVie responsible for commercialization in the U.S., Canada, and certain other countries.
About CReW BP-I:6
This prospective, observational, real-world study evaluated VRAYLAR in 118 adults with BP-I depression, with or without mixed features. The efficacy analysis included 99 patients. Patients with a history of psychiatric conditions—including anxiety, trauma-related, depressive, and attention-related disorders—were included, ensuring the patient population is reflective of the patients clinicians are seeing in everyday practice. The study was an observational, single-arm study, and outcomes were assessed based on changes from baseline.
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).
About ProACt:7
ProACt MDD is an ongoing, prospective, real-world, observational study evaluating adults with MDD who are initiating VRAYLAR as an adjunctive therapy to an antidepressant. Patients with a history of psychiatric conditions including anxiety disorders, trauma, sleep disorders and stress were included, ensuring the patient population is reflective of the patients clinicians are seeing in everyday practice. The study is a single-arm pre-post longitudinal patient-survey study and outcomes were assessed based on changes from baseline.
In an interim analysis of 76 participants, 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). 76.3% of patients 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.