Abstract
The aim of this post-hoc analysis was to evaluate the efficacy of lurasidone in treating major depressive disorder (MDD) with mixed features including irritability. The data in this analysis were derived from a study of patients meeting DSM-IV-TR criteria for unipolar MDD, with a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26, presenting with two or three protocol-defined manic symptoms, and who were randomized to 6 weeks of double-blind treatment with either lurasidone 20-60 mg/d (n=109) or placebo (n=100). We defined "irritability" as a score ≥2 on both the Young Mania Rating Scale (YMRS) irritability item (#5) and the disruptive-aggressive item (#9). Endpoint change in the MADRS and YMRS items 5 and 9 were analyzed using a mixed model for repeated measures for patients with and without irritability. Some 20.7% of patients met the criteria for irritability. Treatment with lurasidone was associated with a significant week 6 change vs. placebo in MADRS score in both patients with (-22.6 vs. -9.5, p<0.0001, effect size [ES]=1.4) and without (-19.9 vs. -13.8, p<0.0001, ES=0.7) irritability. In patients with irritable features, treatment with lurasidone was associated with significant week 6 changes vs. placebo in both the YMRS irritability item (-1.4 vs. -0.3, p=0.0012, ES=1.0) and the YMRS disruptive-aggressive item (-1.0 vs. -0.3, p=0.0002, ES=1.2). In our post-hoc analysis of a randomized, placebo-controlled, 6-week trial, treatment with lurasidone significantly improved depressive symptoms in MDD patients with mixed features including irritability. In addition, irritability symptoms significantly improved in patients treated with lurasidone.
Highlights
Irritability frequently occurs in patients with a diagnosis of major depressive disorder (MDD), with prevalence estimates ranging from 35 to 55%.1–7 As noted in the Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM–5),[8] many individuals with a diagnosis of MDD report or exhibit irritability
The data utilized in our post-hoc analysis were derived from a study designed to evaluate the efficacy of lurasidone for the treatment of patients with MDD presenting with subthreshold hypomanic symptoms
A total of 43 patients (20.7%) had irritable features based on the presence of both Young Mania Rating Scale (YMRS) items 5 and 9 criteria at study baseline; 134 (64.4%) had irritable features based on the presence of the YMRS item 5 criterion; 47 (22.6%) had irritable features based on the presence of the YMRS item 9 criterion; and 118 (56.7%) had irritable features based on a modified SCID–CT assessment
Summary
Irritability frequently occurs in patients with a diagnosis of major depressive disorder (MDD), with prevalence estimates ranging from 35 to 55%.1–7 As noted in the Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM–5),[8] many individuals with a diagnosis of MDD report or exhibit irritability. Irritability frequently occurs in patients with a diagnosis of major depressive disorder (MDD), with prevalence estimates ranging from 35 to 55%.1–7. (DSM–5),[8] many individuals with a diagnosis of MDD report or exhibit irritability. Irritability is not included in the core diagnostic criteria for MDD, nor is it evaluated as a symptom domain in many of the most widely used scales that measure depression severity (e.g., the Montgomery–Åsberg Depression Rating Scale [MADRS], the Hamilton Rating Scale for Depression [HAM–D], the Quick Inventory of Depressive Symptomatology–Self-Report [QIDS–SR16], and the Patient Health Questionnaire–9 [PHQ–9]).
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