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The Effect of Caloric Restriction on Working Memory in Healthy Non CNS Spectrums (2020), 25, 50–63. © Cambridge University Press 2019. This is an Open Access article, distributed under the terms of the Creative Commons Attribution licencehttp://creativecommons.org/licenses/by/4.0/ ( ), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited. doi:10.1017/S1092852919000750 ORIGINAL RESEARCH Clinical implications of directly switching antidepressants in well-treated depressed patients with treatment-emergent sexual dysfunction: a comparison between vortioxetine and escitalopram Paula L. Jacobsen,1* George G. Nomikos,1 Wei Zhong,2 Andrew J. Cutler,3 John Affinito1 and Anita Clayton4 1 Clinical Science, Takeda Development Center Americas, Inc., Deerfield, Illinois, USA 2 CNS Statistics, Takeda Development Center Americas, Inc., Deerfield, Illinois, USA 3 Meridien Research, Bradenton, Florida, USA 4 Department of Psychiatry & Neurobehavioral Sciences, University of Virginia, Charlottesville, Virginia, USA Objective: The objective of this work was to describe treatment-emergent sexual dysfunction (TESD) and tolerability following a switch from selective serotonin reuptake inhibitor (SSRI: citalopram, paroxetine, or sertraline) monother- apy to vortioxetine or escitalopram monotherapy in adults with well-treated major depressive disorder (MDD) and SSRI-induced sexual dysfunction. Methods: Data were analyzed from the primary study, an 8-week, randomized, double-blind, head-to-head study in which participants with well-treated depressive symptoms but experiencing TESD with SSRIs were directly switched to flexible doses (10/20 mg) of vortioxetine or escitalopram. Sexual functioning was assessed by the Changes in Sexual Functioning Questionnaire-14 (CSFQ-14), efficacy by the Montgomery–Åsberg Depression Rating Scale scores (MADRS) and Clinicians Global Impression of Severity/Improvement (CGI-S/CGI-I), and tolerability by adverse events. Efficacy and tolerability were assessed by pre-switch SSRI therapy where possible, and by participant characteristics. Results: Greater improvements in TESD were seen in the vortioxetine compared with escitalopram groups based on: participant demographics (≤45 years, women; P = 0.045), prior SSRI treatment (P = 0.044), number of prior major depressive episodes (MDEs) (1–3; P = 0.001), and duration of prior SSRI therapy (>1 year; P = 0.001). Prior SSRI treat- ment did not appear to influence the incidence or severity of TEAEs, except for nausea. Regardless of prior SSRI, both treatments maintained antidepressant efficacy after 8 weeks. Conclusion: Results suggest that vortioxetine is a safe and effective switch therapy for treating SSRI-induced sexual dysfunction in adults with well-treated MDD. Also, improvement in sexual dysfunction with vortioxetine or escitalopram may be influenced by prior SSRI usage, sex, age, and history of MDEs. Received 24 October 2018; Accepted 7 January 2019 Key words: Vortioxetine, escitalopram, selective serotonin reuptake inhibitor, major depressive disorder, treatment-emergent sexual dysfunction, direct antidepressant switch, citalopram, paroxetine, sertraline. Introduction treatment with serotonergic antidepressants, such as selective serotonin reuptake inhibitors (SSRIs) and sero- Sexual dysfunction is a prevalent symptom of major tonin norepinephrine reuptake inhibitors (SNRIs). depressive disorder (MDD) as well as a side effect of Antidepressant treatment may improve sexual dysfunc- *Address correspondence to: Paula L. Jacobsen, Clinical Science, Takeda tion in some individuals, as sexual functioning may Development Center Americas, Inc., One Takeda Parkway, Deerfield, IL improve as depressive symptoms improve.1–3 However, 60015 USA. (Email: [email protected]) StudyRegistryID: NCT01364649; url: https://clinicaltrials.gov/ct2/ treatment-emergent sexual dysfunction (TESD) is a show/NCT01364649 common side effect of serotonergic antidepressant drug Downloaded from https://www.cambridge.org/core. IP address: 170.106.35.234, on 25 Sep 2021 at 16:03:31, subject to the Cambridge Core terms of use, available at https://www.cambridge.org/core/terms. https://doi.org/10.1017/S1092852919000750 CLINICAL IMPLICATION OF ANTIDEPRESSANT SWITCHING therapy, with an estimated prevalence ranging from sertraline, or paroxetine), but whose depressive symp- 4% to 73%, depending on the antidepressant adminis- toms are well-treated, a head-to-head trial of vortioxetine tered.3–5 This broad prevalence range may reflect the vs. escitalopram (an SSRI) was conducted. Results of the variation in TESD rates among antidepressant agents, primary study have been previously published.15 The but it may also be impacted by patient demographics primary analyses demonstrated that vortioxetine was and differences in assessment tools used across studies.6 superior to escitalopram in improving SSRI-induced sex- SSRIs and SNRIs affect all three phases of the ual dysfunction as assessed by the Changes in Sexual sexual response cycle (desire, arousal, and orgasm).3,5,7 Functioning Questionnaire-14 (CSFQ-14), while main- Moreover, TESD may be seen early in treatment and per- taining antidepressant efficacy in adult men and women sist after depressive symptoms have been moderated. with MDD. Greater improvements were seen in the vor- Sexual dysfunction is reported as one of the most bother- tioxetine group compared with the escitalopram group some side effects of SSRI and SNRI treatment and can on all five dimensions of the CSFQ-14, and were signifi- reduce self-esteem and quality of life and burden inter- cantly superior on four of five dimensions. Vortioxetine personal relationships.2,4,7–12 was significantly superior to escitalopram on all three MDD is a recurrent and often chronic condition phases of the sexual functioning cycle assessed by the requiring long-term treatment. In a study of antidepres- CSFQ-14. Although the study was not powered to detect sant usage in the USA in the years between 2011 and differences between subgroups, greater improvements in 2014, approximately 21% of men and 27% of women sexual functioning were observed in vortioxetine-treated reported having taken antidepressant treatment for 10 patients compared with escitalopram-treated patients or more years.13 Patients with adequately treated depres- when assessed according to sex, age, and baseline sive symptoms who are experiencing TESD may not men- CGI-S scores.15 tion their sexual side effects to their prescriber, which The objective of the current study is to provide addi- may lead to noncompliance with treatment or discontinu- tional descriptive characteristics and prespecified and ation of treatment altogether.3,14 post-hoc analyses of TESD, antidepressant efficacy, Management strategies to alleviate TESD include dos- and tolerability as a result of directly switching adults ing changes, drug holidays, add-on therapies to alleviate with well-treated MDD but with SSRI-induced sexual sexual dysfunction (such as with bupropion), and switch- dysfunction from SSRI monotherapy to vortioxetine or ing to another antidepressant.15–17 Switching to a differ- escitalopram monotherapy. Prespecified analyses ent antidepressant is common with patients who are not included CSFQ-14 individual item level analyses for adequately responding to treatment; however, there is a the vortioxetine vs. escitalopram groups. Post-hoc analy- lack of controlled studies evaluating directly switching ses included the measurement of CSFQ-14 total scores antidepressants in patients whose depressive symptoms for the escitalopram or vortioxetine groups based on are adequately treated by their existing antidepressant.18 pre-switch SSRI and sex. Additional analyses were con- More studies are needed to evaluate the effects of switch- ducted to determine the influence of baseline factors ing therapy with regard to improvement in TESD, main- such as age, duration of prior SSRI treatment, history tenance of antidepressant efficacy, and experience of of MDD treatment, number of previous major depressive adverse events, and to identify patient-specific character- episodes (MDEs), and any history of childhood traumatic istics, such as prior SSRI treatment, age, or MDD history, events on the CSFQ-14 total score after vortioxetine or impacting these outcomes. escitalopram treatment. The efficacy of vortioxetine or Vortioxetine is a multimodal antidepressant for the escitalopram for the treatment of depressive symptoms treatment of MDD. It combines two pharmacological was compared to pre-switch SSRI efficacy against symp- modes of action: direct modulation of 5-HT receptor toms. Finally, treatment-emergent adverse events activity and serotonin reuptake inhibition.19–21 During (TEAEs) were analyzed for both vortioxetine and escita- the vortioxetine development program, several random- lopram according to the baseline factors mentioned ized, placebo-controlled trials in adults with MDD were above. Additional analyses regarding nausea were con- conducted that prospectively assessed TESD using the ducted because this was the most frequently reported Arizona Sexual Experiences Scale (ASEX).22–26 The data TEAE in participants treated with vortioxetine in the from these studies indicated that lower doses of vortiox- primary study. etine had incidences of TESD similar to placebo, and while TESD increased with increasing dose, no vortioxe- Methods tine dose had a significantly greater risk of developing Study design TESD compared with placebo.27 To assess the effects of directly switching
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