0642 Effect of Iloperidone on Sleep Symptoms in Bipolar Patients with Manic and Mixed Episodes: A Randomized, Placebo Controlled Study

Abstract Introduction Iloperidone, a dopamine D2 receptor and serotonin 5HT2A antagonist, was evaluated for the treatment of acute manic mixed episodes associated with bipolar I disorder in adults phase 3 clinical trial. A core symptom is disturbance sleep. During this commonly presents as reduced need sleep studies finding that 69%–99% individuals report lessened or difficulties falling and/or staying asleep. Here we present post hoc analysis evaluating iloperidone effects on component Young Mania Rating Scale (YMRS) patients which addresses both component. Methods This multicenter, randomized, double-blind, placebo-controlled, parallel-group study disorder. Patients received four weeks double-blind treatment. The primary demonstrating an overall improvement from baseline YMRS score assigned versus placebo (p = 0.000008) at end (week 4). item level changes single items including intent-to-treat population (N 392) using mixed-effects model repeated measures approach. Results least squares mean difference (LSMD) change to day 28 statistically significant favor (iloperidone -1.26, -0.95; p 0.008). Conclusion In addition improving mania symptoms reported by YMRS, improvements were also seen treated included assessments decreased denial Support (if any) work supported Vanda Pharmaceuticals Inc.