AbbVie (NYSE: ABBV) presented results from two prospective real-world observational studies of Vraylar (cariprazine) at Psych Congress 2026 in New Orleans, examining the drug's performance in patients with major depressive disorder (MDD) and bipolar I disorder (BP-I).

In the CReW BP-I study, 118 adults with BP-I depression were treated with Vraylar in routine clinical practice. After 12 weeks, mean Montgomery-Åsberg Depression Rating Scale scores fell from 32.2 at baseline to 19.9, while Functional Assessment Short Test scores dropped from 43.4 to 30.7. Nausea and dizziness were each reported as adverse events in 5.1% of patients.

In an interim analysis of the ProACt study, which evaluated adjunctive Vraylar in 76 MDD patients, mean PHQ-9 scores decreased from 15.7 at baseline to 7.1 at week six. Approximately 76% of participants reached minimal or mild depression severity by week six. Functioning scores also improved, along with measures of motivation, energy, and anhedonia.

Both studies were single-arm, observational designs with outcomes assessed from baseline, and included patients with co-occurring psychiatric conditions such as anxiety and trauma-related disorders.

AbbVie also presented an indirect comparative analysis of Vraylar and lumateperone as adjunctive MDD treatments, long-term pediatric safety data showing Vraylar was generally well tolerated in pediatric patients with BP-I, schizophrenia, or autism spectrum disorder, and survey results indicating most MDD patients preferred augmenting their existing antidepressant rather than switching therapies after an inadequate response.

Vraylar is FDA-approved for adjunctive treatment of MDD in adults, depressive and manic episodes associated with BP-I, and schizophrenia. According to AbbVie, more than 1.9 million patients have been treated with the drug since its 2015 approval. The information in this article is based on a press release issued by AbbVie.