Effect of Lurasidone on Sexual Function in Major Depressive Disorder Patients With Subthreshold Hypomanic Symptoms (Mixed Features): Results From a Placebo-Controlled Trial.

OBJECTIVE: The aim of this secondary analysis was to evaluate whether treatment with lurasidone was associated with impairment in sexual functioning in major depressive disorder (MDD) patients with subthreshold hypomanic symptoms (mixed features).

METHODS: Patients meeting DSM-IV-TR criteria for MDD, who presented with 2 or 3 protocol-specified manic symptoms, were randomized to 6 weeks of double-blind treatment with flexible doses of either lurasidone 20-60 mg/d (n = 109) or placebo (n = 100). The study was conducted between September 2011 and October 2014. Change in sexual functioning was assessed utilizing the 14-item self-report Changes in Sexual Functioning Questionnaire (CSFQ-14) administered at baseline and week 6 endpoint. Change from baseline to week 6 in depression severity was assessed utilizing the Montgomery-Asberg Depression Rating Scale (MADRS) total score, the primary efficacy endpoint.

RESULTS: Lurasidone significantly reduced mean MADRS total scores at week 6 endpoint (-20.5 vs -13.0; P < .001). Treatment with lurasidone was associated with significant endpoint improvement in CSFQ total scores versus placebo (+5.1 vs +3.1; P < .05). Fewer patients treated with lurasidone versus placebo shifted from normal to abnormal sexual function. The proportion of patients with a baseline-to-endpoint shift from normal to abnormal sexual function was smaller for lurasidone versus placebo (1.9% vs 4.3%; CSFQ criteria) at study endpoint. Use of higher lurasidone doses was not associated with greater impairment in sexual functioning. No treatment-emergent adverse events related to sexual function were reported during lurasidone treatment.

CONCLUSIONS: In this secondary analysis of a placebo-controlled trial involving patients with MDD and mixed features, lurasidone was not associated with treatment-related sexual dysfunction. These findings were consistent across both structured assessments using a validated sexual functioning questionnaire (CSFQ) as well as adverse event reporting.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01421134.