Evidence indicates that manic symptoms, below the threshold for hypomania (mixed features), are common in individuals with major depressive disorder (MDD).

To evaluate the effect of lurasidone on specific depressive and manic symptoms, based on Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) items, in patients with MDD with mixed features.

Patients meeting DSM-IV-TR criteria for MDD, who presented with 2–3 protocol-specified manic symptoms, were randomized to 6 weeks of double-blind treatment with lurasidone monotherapy 20–60mg/d (n=109) or placebo (n=100). Change from baseline in the MADRS total, MADRS-6 core depression subscale, individual MADRS items, and total and individual items of the YMRS were analyzed by MMRM, and Cohen's d effect sizes (d) were calculated for week 6 change scores.

Lurasidone improved depressive symptoms at week 6 in the MADRS total score (–20.5 vs. –13.0; P<0.0001; d=0.8) and MADRS-6 core depression score (–13.0 vs. –8.5; P<0.0001; d=0.7). Significant improvement on lurasidone was observed at week 6 on all ten MADRS items (d=0.36–0.78). Effect sizes for the MADRS-6 core depression subscale items ranged from 0.36 to 0.78 at week 6. Treatment with lurasidone was associated with significantly greater week 6 improvement on the YMRS (–7.0 vs. –4.9; P<0.0001). Effect sizes for the 5 YMRS items with baseline item severity≥2 ranged from 0.32 to 0.48.

In this study of MDD with mixed features, lurasidone was effective in treating the range of depressive and manic symptoms that patients presented with.

Sponsored by Sunovion Pharmaceuticals Inc.