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Latuda not tied to sexual dysfunction in major depression

Results from a secondary analysis of a placebo-controlled trial demonstrated that Latuda was not tied to treatment-related sexual dysfunction in patients with major depressive disorder and mixed features.

“Treatment-emergent onset of sexual dysfunction commonly occurs, in a dose-related fashion, with antidepressant therapy, most notably with selective serotonin reuptake inhibitor antidepressants,” Anita H. Clayton, MD, from the department of psychiatry and neurobehavioral sciences, University of Virginia, and colleagues wrote. “It is not currently known whether the presence of mixed features is associated with increased rates of sexual dysfunction when compared to depression in patients without mixed features.”

Prior placebo-controlled trial results showed that Latuda (lurasidone, Sunovion) was an efficacious treatment for patients with major depressive disorder with subthreshold hypomanic features (mixed features). In the current study, published in the Journal of Clinical Psychiatry, the researchers reported the effect of lurasidone compared with placebo on sexual functioning based on the standard 14-item self-report version of the Changes in Sexual Functioning Questionnaire.

Patients with MDD, who presented with two or three protocol-specified manic symptoms, were randomly allocated to receive 6 weeks of double-blind treatment with flexible doses of lurasidone 20 mg to 60 mg per day (n = 109) or placebo (n = 100). The investigators administered the questionnaire at baseline and week 6 (endpoint) to determine the change in sexual functioning. They also examined change from baseline to week 6 in depression severity via the Montgomery-Asberg Depression Rating Scale (MADRS).

The results showed that treatment with lurasidone significantly reduced mean depression severity compared with treatment with placebo among patients with MDD as measured by the MADRS (–20.5 vs. –13). Additionally, more patients treated with lurasidone than with placebo met week 6 endpoint criteria for response (64.8% vs. 30%) and remission (49.1% vs. 23%). Mean change from baseline to week 6 endpoint in sexual functioning also favored lurasidone over placebo (+5.1 vs +3.1). According to the results, fewer patients treated with lurasidone shifted from normal to abnormal sexual function than those treated with placebo.

At study endpoint, the proportion of patients with a baseline-to-endpoint shift from normal to abnormal sexual function was smaller among patients who received lurasidone than among those who received placebo (1.9% vs. 4.3%). Use of higher lurasidone doses was not tied to greater impairment in sexual functioning, the results showed. Furthermore, participants reported no treatment-emergent adverse events related to sexual function during treatment with lurasidone.

“Lurasidone was not associated with treatment-related sexual dysfunction in this secondary analysis of a placebo-controlled trial involving patients with MDD and mixed features,” Clayton and colleagues wrote. “Further study is needed to determine whether the current results extend to patients with non-mixed forms of MDD or other diagnoses for which lurasidone may be utilized.” – by Savannah Demko

Disclosures: Clayton reports grants from Axsome, Endoceutics, Janssen, Palatin Technologies, Sage Therapeutics and Takeda; being on the advisory board and/or receiving consultant fees from Alkermes, AMAG Pharmaceuticals, Fabre-Kramer, Ivix, Palatin Technologies, S1 Biopharma, Sprout Pharmaceuticals, Takeda and Valeant Pharmaceuticals. She also reports royalties from Ballantine Books/Random House and Guilford Publications; copyright for the Changes in Sexual Functioning Questionnaire; and shares/restricted stock units from Euthymics and S1 Biopharma. Please see the study for all other authors’ relevant financial disclosures.