The following article is a part of conference coverage from Psych Congress 2021 , held October 29th through November 1, 2021, in San Antonio, Texas. The team at Psychiatry Advisor will be reporting on the latest news and research conducted by leading experts in psychiatry. Check back for more from the Psych Congress 2021.
No difference in sexual functioning was observed among patients with major depressive disorder who were treated with zuranolone therapy compared with those who received placebo, according to study results recently presented at Psych Congress 2021, held from October 29 to November 1, 2021, in San Antonio, Texas.
Investigators of this post hoc analysis of the MOUNTAIN study (ClinicalTrials.gov Identifier: NCT03672175) sought to assess the effect of zuranolone vs placebo on the sexual functioning of 581 adults with major depressive disorder. Patients were randomly assigned to receive zuranolone 20 mg (n=258), zuranolone 30 mg (n=166), or placebo (n=157) for a 2-week period. All participants had a total score at least 22 on the 17-item Hamilton Depression Rating Scale and self-reported sexual functioning using the Changes in Sexual Functioning Questionnaire-14 (CSFQ-14) at baseline and at days 15, 28, and 42. The investigators applied validated thresholds for sexual dysfunction using a CSFQ-14 total score of ≤41 for women and ≤47 for men. The focus of analysis was on the zuranolone 30-mg group and placebo group.
In the zuranolone 30-mg group, the mean baseline CSFQ-14 score for women (n=121) was 31.7 and for men (n=45) was 42.1; in the placebo group, the mean baseline CSFQ-14 score for women (n=106) was 33.7 and for men (n=51) was 40.9. No significant differences in change in sexual functioning scores were reported between treatment and placebo cohorts for either gender from baseline to day 15 (female patients: +4.0 [0.83] vs +2.7 [0.74]; male patients: +1.3 [1.28] vs +1.7 [1.23]); day 28 (female patients: +3.3 [0.80] vs +3.1 [0.82]; male patients: +1.7 [1.31] vs +2.0 [1.30]); and day 42 (female patients: +3.6 [0.87] vs +2.9 [0.88]; male patients: +2.2 [1.33] and +3.5 [1.54]).
Neither women nor men who received zuranolone 30 mg vs placebo in the MOUNTAIN study reported impairment of sexual functioning. The study investigators suggested that zuranolone is not associated with treatment-emergent sexual dysfunction and support further development of zuranolone for the treatment of major depressive disorder.
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Clayton A, Nandy I, Lasser R, Brown C, Kanes S. Absence of treatment-related sexual dysfunction in the phase 3, randomized, double-blind, placebo-controlled MOUNTAIN study of zuranolone in patients with major depressive disorder. Presented at: Psych Congress 2021; October 29-November 1, 2021; San Antonio, TX. Poster 33.