Effects of Cariprazine on Reducing Symptoms of Hostility and Agitation in Patients with Manic or Mixed Episodes of Bipolar I Disorder

Abstract: Background: Bipolar mania and mixed episodes can be associated with hostility and agitated behavior. Effects of cariprazine on these symptoms were evaluated in this post hoc analysis. Methods: Data were from 3 placebo-controlled trials of cariprazine 3-12 mg/d in patients with manic/mixed episodes of bipolar I disorder. Post hoc analyses were performed in subgroups of patients with hostility at baseline as defined by YMRS (baseline-irritability and disruptive-aggressive behavior item scores ≥2) or PANSS (baseline-hostility item score ≥2); baseline-agitation was defined by PANSS-EC(total score ≥14 and score ≥4 on ≥1 item). Change (baseline to week-3) in YMRS irritability and disruptive-aggressive behavior item scores, PANSS hostility item and PANSS-EC response (≥40% decrease from baseline) were assessed. Results: Pooled dataset (n=1037) at baseline included 950 and 856 patients with hostility (YMRS-subgroup: placebo=385, cariprazine=565; PANSS-subgroup: placebo=361, cariprazine=495); 299 patients with agitation (placebo=106; cariprazine=193). Cariprazine reduced hostility scores vs placebo in patients with baseline-hostility (YMRS-hostility-subgroup: least squares mean difference [LSMD] YMRS total=-6.3; YMRS irritability=-1.1; YMRS disruptive-aggressive behavior=-0.96; PANSS hostility=-0.6 [P≤.001 each outcome]; PANSS-hostility-subgroup: LSMD YMRS total=-6.7; YMRS irritability=-1.1; YMRS disruptive-aggressive behavior=-0.99; PANSS hostility=-0.6; [P≤.001 each outcome]). Reduction of YMRS hostility-related symptoms remained significant after controlling for other YMRS items (PShort Description: Post hoc analysis assessed effect of cariprazine on symptoms of hostility and agitation associated with bipolar mania and mixed episodes. Cariprazine significantly reduced symptoms of hostility and agitation vs placebo in patients with bipolar mania and high levels of hostility or agitation at baseline.Name of Sponsoring Organization(s): AbbVie