Lurasidone for the Treatment of Major Depressive Disorder with Mixed Features: Do Manic Symptoms Moderate Treatment Response?

Abstract

Background

This post-hoc analysis evaluated whether the efficacy of lurasidone in major depressive disorder (MDD) with mixed features is moderated by the number and characteristics of manic symptoms present at study baseline.

Methods

Patients meeting DSM-IV-TR criteria for MDD who presented with two or three manic symptoms (consistent with the DSM–5 mixed features specifier) were randomly assigned to 6 weeks of double-blind treatment with either lurasidone 20–60 mg/d (n = 109) or placebo (n = 100). Finite mixture models were applied to identify latent class patterns of the 10 baseline manic symptoms.

Results

Three latent class profiles were identified: 105 (50.5%) patients had manic symptom profile 1 (MIX 1) with mean MADRS 33.0, mean YMRS 9.2, mean number of manic symptoms 3.8; 63 (30.3%) patients had manic symptom profile 2 (MIX 2) with similar baseline mean MADRS (32.4) and YMRS (9.3) and lower number of manic symptoms 3.5; 40 patients had manic symptom profile 3 (MIX 3) with significantly higher severity scores in MADRS (35) and YMRS (14.9) and mean number of manic symptoms 4.6. A significant moderating effect on change in YMRS score was observed for the “decreased need for sleep” symptom, with greater lurasidone effect size (vs. Placebo) found in patients without vs. With this symptom (P < 0.05).

Conclusions

In this post-hoc analysis of a placebo-controlled trial involving MDD patients with mixed features, absence of “decreased need for sleep” was found to be significantly associated with improvement in manic and depressive symptoms and to moderate the treatment effect on manic symptoms.

Disclosure of interest

I am full time employee of Sunovion pharmaceuticals Inc.