Abstract
The aim of this post-hoc analysis was to evaluate the efficacy of lurasidone in treating patients with major depressive disorder (MDD) with mixed features who present with mild and moderate-to-severe levels of anxiety. The data in this analysis were derived from a study of patients meeting the 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, who were randomized to 6 weeks of double-blind treatment with either lurasidone 20-60 mg/day (n=109) or placebo (n=100). Anxiety severity was evaluated using the Hamilton Anxiety Rating Scale (HAM-A). To evaluate the effect of baseline anxiety on response to lurasidone, the following two anxiety groups were defined: mild anxiety (HAM-A≤14) and moderate-to-severe anxiety (HAM-A≥15). Change from baseline in MADRS total score was analyzed for each group using a mixed model for repeated measures. Treatment with lurasidone was associated with a significant week 6 change versus placebo in MADRS total score for patients with both mild anxiety (-18.4 vs. -12.8, p<0.01, effect size [ES]=0.59) and moderate-to-severe anxiety (-22.0 vs. -13.0, p<0.001, ES=0.95). Treatment with lurasidone was associated with a significant week 6 change versus placebo in HAM-A total score for patients with both mild anxiety (-7.6 vs. -4.0, p<0.01, ES=0.62), and moderate-to-severe anxiety (-11.4 vs. -6.1, p<0.0001, ES=0.91). In this post-hoc analysis of an MDD with mixed features and anxiety population, treatment with lurasidone was associated with significant improvement in both depressive and anxiety symptoms in subgroups with mild and moderate-to-severe levels of anxiety at baseline.
Highlights
The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM–5) incorporated a new mixedfeatures specifier in order to permit clinicians to note the presence of subthreshold hypomania in patients presenting with a major depressive episode.[1]
The presence of comorbid anxiety in major depressive disorder (MDD) has been found to be associated with greater illness severity, chronicity, and functional impairment.[15,16,17,18]
The data utilized in this post-hoc analysis were based on a study designed to evaluate the efficacy of lurasidone for the treatment of patients with major depressive disorder presenting with subthreshold hypomanic symptoms
Summary
The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM–5) incorporated a new mixedfeatures specifier in order to permit clinicians to note the presence of subthreshold hypomania in patients presenting with a major depressive episode.[1] The available evidence, largely from clinical study populations, suggests that major depressive disorder (MDD) with mixed features may occur in at least 25% of patients with major depression.[2,3,4,5,6,7,8,9,10,11,12]. In patients with a diagnosis of MDD, the estimated lifetime prevalence of an anxiety disorder is greater than 35%.13,14. The presence of comorbid anxiety in MDD has been found to be associated with greater illness severity, chronicity, and functional impairment.[15,16,17,18]. Preliminary research suggests that patients with a diagnosis of MDD with mixed features (subthreshold hypomania) may have rates of anxiety comorbidity in the range of 45–65%.3,11.
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