SAN FRANCISCO—The antipsychotic cariprazine was effective in improving depressive symptoms in patients with bipolar depression and concurrent manic symptoms, according to a poster presented at the American Psychiatric Association’s annual meeting.
The poster analyzed pooled data from 3 randomized, double-blind, placebo-controlled trials, involving 1383 patients with bipolar I disorder and a current depressive episode. Of those patients, 808 (58.4%) patients also had concurrent manic symptoms (mixed features).
In the patients with manic symptoms, cariprazine 1.5 mg/day and 3 mg/day significantly outperformed placebo in the least squares mean change from baseline to week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. The least squares mean differences in the Hamilton Depression Rating Scale (HAMD-17) total score and the Clinical Global Impressions-Severity (CGI-S) score were also significantly higher in the cariprazine group, vs the placebo group, for both dosages.
In patients without manic symptoms, the change on the MADRS and HAMD-17 was significantly in favor of cariprazine for only the 1.5 mg/day dose. However, the CGI-S score change was significantly greater for both dosages in that population.
Rates of response and remission as measured by the MADRS were significantly greater than placebo for both dosages of cariprazine in patients with manic symptoms and for 1.5 mg/day in patients without manic symptoms. Rates of remission according to the CGI-S were significantly greater than placebo for all cariprazine doses in both patient subgroups.
“In a post hoc analysis of data from patients with bipolar depression and concurrent manic symptoms, significant improvement in depressive symptoms was demonstrated for cariprazine vs PBO, suggesting that cariprazine may be an appropriate treatment option for this patient population,” researchers wrote.
Cariprazine, which was previously approved by the US Food and Drug Administration for the treatment of schizophrenia and bipolar mania in adults, was recently approved for the treatment of bipolar depression.
“Cariprazine efficacy in bipolar I depression with and without concurrent manic symptoms: post hoc analysis of 3 randomized, placebo-controlled studies.” Abstract presented at: the American Psychiatric Association Annual Meeting; May 21, 2019; San Francisco, CA.