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Psych Congress  

Paroxetine, but Not Vortioxetine, Impairs Sexual Functioning Compared With Placebo in Healthy Adults

Authors  

Paula Jacobsen, PhD – Takeda Development Center Americas, Inc; Wei Zhong, PhD – Takeda Development Center Americas, Inc; George Nomikos, PhD – Takeda Development Center Americas, Inc; Anita Clayton, MD – University of Virginia School of Medicine

Sponsor  
The study was funded by Takeda Pharmaceuticals U.S.A., Inc. Medical writing assistance, provided by Syneos Health, was supported by Takeda Pharmaceuticals U.S.A., Inc., and H. Lundbeck A/S.

This poster was presented at the 31st annual Psych Congress, held Oct. 25-28, 2018, in Orlando, Florida.

Sexual dysfunction may be associated with major depressive disorder (MDD) or with antidepressant treatment. The antidepressant vortioxetine has shown low rates of treatment-emergent sexual dysfunction (TESD) in MDD trials.

This phase 4, double-blind study compared the effect of vortioxetine (10 and 20 mg) with paroxetine  (20 mg) and placebo on TESD in healthy volunteers, subjects without potentially confounding MDD. Participants completed the Changes in Sexual Functioning Questionnaire-14 (CSFQ-14) weekly. The primary endpoint was change from baseline in CSFQ-14 total score for vortioxetine versus paroxetine at Week 5.

Participants (N=361) were randomized to placebo, paroxetine, vortioxetine 10 mg, or vortioxetine 20 mg. Baseline characteristics were similar among all treatment groups. Vortioxetine 10 mg was associated with significantly less TESD (P=0.009) and vortioxetine 20 mg with numerically less TESD (P=0.303) than paroxetine. Compared with placebo, paroxetine was associated with significantly greater TESD (P=0.007), whereas neither vortioxetine dose was associated with significantly greater TESD than placebo. Change from baseline in CSFQ-14 subscales measuring phases (desire, arousal, orgasm/completion/ejaculation) and dimensions (pleasure, desire/frequency, desire/interest, arousal/erection, orgasm) of sexual dysfunction favored vortioxetine 10 mg versus paroxetine (all P<0.05). Vortioxetine was generally safe and well tolerated.

In summary, vortioxetine 10 mg was associated with significantly less TESD and vortioxetine 20 mg with numerically less TESD than paroxetine. Paroxetine was associated with significantly greater TESD than placebo, whereas neither dose of vortioxetine demonstrated significantly greater TESD than placebo. These findings support previous research showing less TESD in patients with MDD administered vortioxetine versus a different active control.

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