SAN FRANCISCO — Treatment with Vraylar led to significant improvement in depressive symptoms compared with placebo in patients with bipolar depression and concurrent manic symptoms, according to post hoc data presented at the APA annual meeting.
“Approximately 5 million patients suffer with 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, MD, PhD, 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.”
These analyses focused on the efficacy of Vraylar (cariprazine; Allergan plc.) 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.
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.
“In this particular subgroup analysis, we looked at patients with mixed and manic features in the depression study to answer the questions of whether they did better, worse or the same. The results were compelling – no matter which symptoms they had, they responded well,” Stahl said.
Of 1,383 patients, 808 (58.4%) had bipolar depression and concurrent manic symptoms.
Analysis revealed that average change in MADRS score was statistically significant in favor of cariprazine 1.5 mg (–2.5; P = .0033) and 3 mg (–2.9; P = .0010) in patients with manic symptoms and for cariprazine 1.5 mg (–3.3; P = .0008) in patients without manic symptoms compared with placebo.
Similarly, the change in HAMD17 was significant for cariprazine 1.5 and 3 mg (–1.9 and –1.5; P < .05) in patients with manic symptoms and for cariprazine 1.5 mg (–2.2; P = .0042) 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; P < .05), according to the results. Further, rates of MADRS response and remission were greater for cariprazine 1.5 mg (46.6 % and 31.3%; P < .05) and 3 mg (49.8% and 31.4%; P < .01) than for placebo (37.8% and 21%) in patients with manic symptoms and for cariprazine 1.5 mg (45.2% and 32.3%; P < .05) 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,” Stahl told Healio Psychiatry. “We also saw a consistent side effect profile to what we’ve seen in previous trials.” – by Savannah Demko
Stahl SM, et al. Cariprazine Efficacy in Patients with Bipolar Depression and Concurrent Manic Symptoms: Post Hoc Analysis of 3 Randomized, Placebo-Controlled Studies. Presented at: APA Annual Meeting; May 18-22, 2019; San Francisco.
Disclosures: Stahl reports consulting for Allergan.