Effect of Vortioxetine vs. Escitalopram on Sexual Functioning in Adults with Well-Treated Major Depressive Disorder Experiencing SSRI-Induced Sexual Dysfunction.
BACKGROUND
Sexual dysfunction is common with serotonergic antidepressants, including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), and does not resolve in most patients. Vortioxetine, an antidepressant with a multimodal mechanism of action, has shown low rates of sexual dysfunction in previous major depressive disorder (MDD) trials.


OBJECTIVE
This study compared the effects of vortioxetine and escitalopram on sexual functioning in adults with well-treated MDD experiencing treatment-emergent sexual dysfunction (TESD).


METHODS
Participants treated with, and responding to, citalopram, paroxetine, or sertraline were randomized to switch to either vortioxetine (10/20 mg; n = 225) or escitalopram (10/20 mg; n = 222) for 8 weeks. Sexual function was assessed using the Changes in Sexual Functioning Questionnaire Short Form (CSFQ-14), and antidepressant efficacy was assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impressions (CGI) scale, and Profile of Mood States brief form (POMS-brief). Safety and tolerability were also assessed.


METHODS
The primary endpoint was change from baseline in the CSFQ-14 total score after 8 weeks of treatment. The MADRS, CGI, and POMS-brief were used to assess antidepressant efficacy. Safety was assessed via adverse events, vital signs, electrocardiograms, laboratory values, weight, and physical examination findings.


RESULTS
Vortioxetine showed significantly greater improvements in CSFQ-14 total score (8.8 ± 0.64, mean ± standard error) vs. escitalopram (6.6 ± 0.64; P = 0.013). Benefits vs. escitalopram were significant on four of five dimensions and all three phases of sexual functioning assessed by the CSFQ-14 (P < 0.05). Antidepressant efficacy continued in both groups, with similar, but slight, improvements in MADRS and CGI scores. Vortioxetine and escitalopram had similar clinical efficacy profiles in this study, with safety profiles similar to previous trials. Nausea (n = 9, 4.0%) was the most common treatment-emergent adverse event leading to discontinuation of vortioxetine.


CONCLUSIONS
Switching antidepressant therapy to vortioxetine may be beneficial for patients experiencing sexual dysfunction during antidepressant therapy with SSRIs.
Takeda Development Center Americas, Deerfield, IL, USA.
Paula L
PL
Jacobsen
Takeda Development Center Americas, Deerfield, IL, USA.
Atul R
AR
Mahableshwarkar
Takeda Development Center Americas, Deerfield, IL, USA.
Yinzhong
Y
Chen
Takeda Development Center Americas, Deerfield, IL, USA.
Lambros
L
Chrones
University of Virginia, Charlottesville, VA, USA.
Anita H
AH
Clayton
D000293:Adolescent; D000328:Adult; D000368:Aged; D018687:Antidepressive Agents, Second-Generation / Q000008:administration & dosage / Q000009:adverse effects*; D002170:Canada / Q000453:epidemiology; D015283:Citalopram / Q000008:administration & dosage / Q000009:adverse effects*; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000453:epidemiology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects*; D011569:Psychiatric Status Rating Scales; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D012725:Sexual Behavior / Q000187:drug effects* / Q000523:psychology; D020018:Sexual Dysfunctions, Psychological / Q000139:chemically induced* / Q000453:epidemiology / Q000209:etiology / Q000523:psychology; D013440:Sulfides / Q000008:administration & dosage / Q000009:adverse effects*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D000078784:Vortioxetine; D055815:Young Adult
D018687:Antidepressive Agents, Second-Generation; D015283:Citalopram; D010879:Piperazines; D017367:Selective Serotonin Reuptake Inhibitors; D013440:Sulfides; D000078784:Vortioxetine
Escitalopram; Major Depressive Disorder; Treatment-Emergent Sexual Dysfunction; Vortioxetine