Vraylar beneficial for patients with depression, mania

USA: Treatment with Vraylar (cariprazine) may be an effective treatment for depression patients, according to a recent study.

The study, presented at the APA Annual Meeting found that treatment with Vraylar led to significant improvements in depressive symptoms compared with placebo in patients with concurrent manic symptoms and bipolar depression.

Stephen M. Stahl, professor of psychiatry at the University of California San Diego, and colleagues conducted the study to determine the efficacy of Vraylar for bipolar depression and concurrent manic symptoms (mixed features) using pooled data from three randomized, double-blind, placebo-controlled trials in patients with bipolar I disorder and a current major depressive episode.

“Approximately 5 million patients suffer from bipolar I depression, which can be very difficult to treat given the few available therapies. Having research that may support another potential treatment option is encouraging news for this patient population,” Stephen M. Stahl, professor of psychiatry at University of California San Diego, told Healio Psychiatry. “Few treatments are available for patients experiencing both manic and depressive symptoms at the same time, which is very common in bipolar patients. This is a period where patients are at risk for harm to themselves."

The researchers examined efficacy outcomes for groups receiving cariprazine 1.5 mg per day and 3 mg per day compared with those receiving placebo as well as mean change from baseline to week 6 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score, Hamilton Depression Rating Scale (HAMD17) total score, and Clinical Global Impressions-Severity (CGI-S) score. They also assessed MADRS response, MADRS remission, and CGI-S remission.

They found that:

• Of 1,383 patients, 808 (58.4%) had bipolar depression and concurrent manic symptoms.


• An average change in MADRS score was statistically significant in favor of cariprazine 1.5 mg (–2.5) and 3 mg (–2.9) in patients with manic symptoms and for cariprazine 1.5 mg (–3.3) in patients without manic symptoms compared with placebo.


• The change in HAMD17 was significant for cariprazine 1.5 and 3 mg (–1.9 and –1.5) in patients with manic symptoms and for cariprazine 1.5 mg (–2.2) in those without manic symptoms compared with placebo.


• Cariprazine 1.5 and 3 mg also outperformed placebo as measured by the CGI-S score in patients with manic symptoms (–0.24 and –0.25; P < .05) and in patients without (–0.4 and –0.26).


• Rates of MADRS response and remission were greater for cariprazine 1.5 mg (46.6 % and 31.3%) and 3 mg (49.8% and 31.4%) than for placebo (37.8% and 21%) in patients with manic symptoms and for cariprazine 1.5 mg (45.2% and 32.3%) than for placebo (33.3% and 20.7%) in patients without manic symptoms.


• Rates of CGI-S remission were significantly greater for all cariprazine doses compared with placebo in both patient subgroups as well.

“When you pool all studies for Vraylar (cariprazine) in bipolar depression, the general outcome is that it demonstrated efficacy in the full spectrum of bipolar I symptoms – depression, mania, and mixed episodes,” said Stahl. “We also saw a consistent side effect profile to what we’ve seen in previous trials.”