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Vraylar effective for acute bipolar I depression

Results from an 8-week, multinational, multicenter, randomized, double blind placebo-controlled study indicated consistent efficacy of Vraylar, an atypical antipsychotic currently intended for schizophrenia and bipolar I disorder, for acute bipolar I depression.

“Although most atypical antipsychotics are approved by the U.S. Food and Drug Administration (FDA) for acute manic/mixed episodes in bipolar disorder, quetiapine and lurasidone are the only FDA-approved antipsychotics for bipolar depression; lurasidone has not been assessed in bipolar mania and is not indicated for its treatment. Despite the substantial burden of illness, bipolar depression has not been as widely studied as mania, and treatment options remain limited,” Suresh Durgam, MD, of Forest Research Institute, Jersey City, N.J., and colleagues wrote.

To evaluate efficacy, safety and tolerability of Vraylar (cariprazine, Actavis Pharma, Inc), researchers randomly assigned 571 adults with acute bipolar I depression to receive placebo or cariprazine at 0.75, 1.5 or 3 mg/day for 8 weeks. Changes in Montgomery-Åsberg Depression Rating Scale (MADRS) and the Clinical Global Impressions severity subscale (CGI-S) scores from baseline to week 6 were primary and secondary efficacy measures.

Participants who received 1.5 mg/day of cariprazine exhibited significantly greater improvement on MADRS total score change from baseline to week 6 compared with placebo, with a least squares mean difference of –4 (95% CI, –6.3 to –1.6; adjusted P = .003).

Participants who received 3 mg/day of cariprazine had greater reductions in MADRS scores than placebo (–2.5; 95% CI, –4.9 to –0.1; P = .037).

Participants who received 1.5 mg/day of cariprazine exhibited significant improvement in CGI-S scores compared with those who received placebo, with a least squares mean difference of –0.4 (95% CI, –0.6 to –0.1; adjusted P = .013).

Greater CGI-S score reduction occurred among participants who received 3 mg/day of cariprazine compared with placebo, with a least squares mean difference of –0.3 (95% CI, –0.5 to –0.0; P = .049); however, this difference was not significant when adjusting for multiplicity.

Score changes among participants who received 0.75 mg/day of cariprazine were not significantly different from those who received placebo.

Akathisia and insomnia were the most common adverse events. Weight gain was slightly higher among those who received cariprazine.

“Cariprazine was generally well tolerated. Of the cariprazine dosages studied, 1.5 mg/day demonstrated the most robust efficacy and good safety, suggesting that it may be an effective dosage for the treatment of bipolar I depression,” Durgam and colleagues wrote. “Given the limited number of positive studies for atypical antipsychotics in bipolar I depression, future studies are warranted to extend these phase II findings.” – by Amanda Oldt

Disclosure: The study was supported by Forest Laboratories, an Allergan affiliate (Jersey City), and Gedeon Richter (Budapest). Durgam reports employment and having stock in Allergan. Please see the full study for a list of all authors’ relevant financial disclosures.