Studies Support Cariprazine as Adjunctive Treatment for Major Depressive Disorder

Cariprazine demonstrated a statistically significant change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score in patients with major depressive disorder (MDD) at 6 weeks, according to the top-line results of Study 3111-301-001. The phase 3 clinical trial evaluated the efficacy and safety of cariprazine as an adjunctive treatment for these patients.

In a second trial, Study 3111-302-001, cariprazine demonstrated numerical improvement in depressive symptoms from baseline to week 6 but did not achieve statistical significance.

“When added to ongoing antidepressant treatment that has produced inadequate response in patients with major depressive disorder, cariprazine has now demonstrated that it can further improve depressive symptoms by providing statistically significant and clinically meaningful improvements compared to placebo in two large, well-controlled registrational clinical trials,” said Michael Severino, MD, vice chairman and president of AbbVie, in a press release. “Major depressive disorder is one of the most common and serious mental illnesses, and more than half of these patients never experience satisfactory results from this debilitating condition. Based on the results, we believe cariprazine has the potential to benefit these patients as an adjunctive treatment.”

Previously published phase 2/3 study results demonstrated that patients treated with cariprazine flexible doses of 2.0–4.5 mg/day, in addition to ongoing antidepressant therapy, achieved improved MADRS total scores at week 8 compared to placebo. Based on these results in combination with the results of Study 3111-301-001, AbbVie intends to submit a supplemental New Drug Application to the FDA for the expanded use of cariprazine for the adjunctive treatment of MDD.

Safety results for cariprazine remained consistent with its established safety profile across all 3 studies, with no new safety signals identified. The most common adverse events included akathisia, nausea, insomnia, headache, and somnolence.

Cariprazine is an oral, once-daily atypical antipsychotic approved for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder and for the treatment of depressive episodes associated with bipolar I disorder in adults. It is also approved for the treatment of adults with schizophrenia.


AbbVie's Cariprazine (VRAYLAR®) met primary endpoint in phase 3 study as an adjunctive treatment for major depressive disorder [news release]. AbbVie; October 29, 2021. Accessed October 29, 2021.

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