Lurasidone treatment of major depression with mixed features: Effect on sexual function

Abstract

Introduction Sexual dysfunction is common in major depressive disorder (MDD), and frequently is worsened by antidepressant treatment. Objectives/aims To evaluate the effect of lurasidone on sexual functioning as measured by the Changes in Sexual Functioning Questionnaire (CSFQ) in patients with MDD with mixed features. Methods Patients meeting DSM-IV-TR criteria for MDD, who presented with 2 or 3 protocol-specified manic symptoms, were randomized to 6weeks of double-blind treatment with either lurasidone monotherapy 20–60mg/d ( n =109) or placebo ( n =100). Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total at week 6 was the primary efficacy endpoint, analyzed by MMRM. The CSFQ was assessed at baseline and week 6, analyzed by ANCOVA (LOCF). Results The mean CSFQ total scores at baseline were 36.5 and 34.1 in the lurasidone and placebo groups, respectively. Sexual function was rated as abnormal at baseline on the CSFQ by 77.8% of patients on lurasidone and 89.8% of patients on placebo. Treatment with lurasidone was associated with significant improvement in CSFQ total scores at week 6 (LOCF) compared with placebo (+5.1 vs. +3.1; P Conclusion Lurasidone treatment of MDD with mixed features was associated with significant improvement in sexual function.