Cariprazine Eases Depressive Symptoms in Bipolar I Disorder
ORLANDO, Fla.—The atypical antipsychotic cariprazine outperformed placebo in reducing depressive symptoms in patients with bipolar I disorder, according to a poster presented at Psych Congress 2018.
The drug currently is approved for the treatment of adults with schizophrenia or manic or mixed episodes associated with bipolar I disorder. Researchers conducted the study after earlier trial results suggested cariprazine also eased depressive symptoms in patients with bipolar I disorder.
This phase 3 double-blind trial compared 2 different doses of cariprazine against placebo in patients with bipolar I disorder who were experiencing a current depressive episode lasting at least 4 weeks but no more than 12 months. The study randomized 168 participants to cariprazine 1.5 mg/day, 158 participants to cariprazine 3 mg/day, and 167 participants to placebo over 6 weeks.
Cariprazine 1.5 mg/day significantly improved depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale and the Clinical Global Impressions–Severity scale, compared with placebo, researchers reported. Cariprazine 3 mg/day numerically improved scores on both scales compared with placebo.
Both cariprazine doses were generally well tolerated, according to the poster. Common treatment-emergent adverse events, which occurred in 5% or more of participants taking cariprazine and at twice the rate of placebo, were akathisia, restlessness, nausea, and fatigue.
In both cariprazine groups, mean weight gain was 0.5 kg or less, researchers reported.
Allergan plc and Gedeon Richter, which market cariprazine respectively as Vraylar in the United States and Reagila in Europe, sponsored the study. Last month, Allergan plc submitted a supplemental New Drug Application to the US Food and Drug Administration to expand Vraylar’s indication to include the treatment of depressive episodes associated with bipolar I disorder in adults.
Earley W, Burgess M, Khan B, et al. Cariprazine for bipolar I depression: a randomized double-blind placebo-controlled trial. Poster presented at Psych Congress 2018: October 25-28, 2018; Orlando, FL. Poster 112.