Lurasidone was not associated with treatment-related sexual dysfunction, according to clinical trial data published in the Journal of Clinical Psychiatry.
Researchers conducted a secondary analysis of a placebo-controlled trial regarding the treatment efficacy of lurasidone for major depressive disorder with subthreshold hypomanic symptoms. Patients were randomly assigned to either lurasidone 20 to 60 mg/day (n=109) or placebo (n=100). Sexual functioning was assessed via self-report on the Changes in Sexual Functioning Questionnaire at baseline and after 6 weeks of treatment. In addition, changes in depression severity were captured using the Montgomery-Asberg Depression Rating Scale and the Clinical Global Impression-Severity scale at each point.
The mean daily dose of lurasidone for study participants was 36.2 mg, and study completion rates were high among both the lurasidone group (93.6%) and the placebo group (85.3%). Adverse events related to sexual dysfunction were not reported by any patients randomly assigned to lurasidone treatment. Lurasidone was associated with significant changes in depressive symptoms at the 6-week study endpoint compared with placebo (P <.001). In addition, just 1.9% of patients randomly assigned to lurasidone experienced abnormal sexual function during the study compared with 4.3% of placebo-assigned participants. The mean score improvement on the Changes in Sexual Functioning Questionnaire from baseline to endpoint was +5.1 for the lurasidone group compared with +3.1 for the placebo group (P <.05).
These data suggest that lurasidone is effective in treating major depressive disorder with subthreshold manic (ie mixed) features without introducing sexual dysfunction. These results were validated across structured questionnaires and adverse event reporting, solidifying the potential utility of lurasidone in treating depression with mixed features.
Disclosures: The Sunovion authors (Dr Tsai, Dr Mao, Dr Pikalov, and Dr Loebel) participated in the study design, data collection, and analysis and interpretation of data; drafting, reviewing, and approving the current paper; and making the decision to submit the paper for publication. Several researchers disclosed ties to the pharmaceutical industry. See full study for a full list of disclosures.
Clayton AH, Tsai J, Mao Y, Pikalov A, Loebel A. Effect of lurasidone on sexual function in major depressive disorder patients with subthreshold hypomanic symptoms (mixed features): results from a placebo-controlled trial. J Clin Psychiatry. 2018;79(5):18m12132