Skip to main content Accessibility help
×
Home

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 (a1), George G. Nomikos (a1), Wei Zhong (a2), Andrew J. Cutler (a3), John Affinito (a1) and Anita Clayton (a4)...

Abstract

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) monotherapy 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 treatment 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.

  • View HTML
    • Send article to Kindle

      To send this article to your Kindle, first ensure no-reply@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about sending to your Kindle. Find out more about sending to your Kindle.

      Note you can select to send to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

      Find out more about the Kindle Personal Document Service.

      Clinical implications of directly switching antidepressants in well-treated depressed patients with treatment-emergent sexual dysfunction: a comparison between vortioxetine and escitalopram
      Available formats
      ×

      Send article to Dropbox

      To send this article to your Dropbox account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Dropbox.

      Clinical implications of directly switching antidepressants in well-treated depressed patients with treatment-emergent sexual dysfunction: a comparison between vortioxetine and escitalopram
      Available formats
      ×

      Send article to Google Drive

      To send this article to your Google Drive account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Google Drive.

      Clinical implications of directly switching antidepressants in well-treated depressed patients with treatment-emergent sexual dysfunction: a comparison between vortioxetine and escitalopram
      Available formats
      ×

Copyright

This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.

Corresponding author

*Address correspondence to: Paula L. Jacobsen, Clinical Science, Takeda Development Center Americas, Inc., One Takeda Parkway, Deerfield, IL 60015 USA. (Email: pjakes1@gmail.com)

Footnotes

Hide All

Study Registry ID: NCT01364649; url: https://clinicaltrials.gov/ct2/show/NCT01364649

Footnotes

References

Hide All
1. Gelenberg, AJ, Dunner, DL, Rothschild, AJ, Pedersen, R, Dorries, KM, Ninan, PT. Sexual functioning in patients with recurrent major depressive disorder enrolled in the PREVENT study. J Nerv Ment Dis. 2013; 201(4): 266273.
2. Ishak, WW, Christensen, S, Sayer, G, et al. Sexual satisfaction and quality of life in major depressive disorder before and after treatment with citalopram in the STAR*D study. J Clin Psychiatry. 2013; 74(3): 256261.
3. Montejo, AL, Llorca, G, Izquierdo, JA, Rico-Villademoros, F. Incidence of sexual dysfunction associated with antidepressant agents: a prospective multicenter study of 1022 outpatients. Spanish Working Group for the Study of Psychotropic-Related Sexual Dysfunction. J Clin Psychiatry. 2001; 62 Suppl 3: 1021.
4. Williams, VS, Edin, HM, Hogue, SL, Fehnel, SE, Baldwin, DS. Prevalence and impact of antidepressant-associated sexual dysfunction in three European countries: replication in a cross-sectional patient survey. J Psychopharmacol. 2010; 24(4): 489496.
5. Clayton, AH, Pradko, JF, Croft, HA, et al. Prevalence of sexual dysfunction among newer antidepressants. J Clin Psychiatry. 2002; 63(4): 357366.
6. Serretti, A, Chiesa, A. Treatment-emergent sexual dysfunction related to antidepressants: a meta-analysis. J Clin Psychopharmacol. 2009; 29(3): 259266.
7. Clayton, A, Kornstein, S, Prakash, A, Mallinckrodt, C, Wohlreich, M. Changes in sexual functioning associated with duloxetine, escitalopram, and placebo in the treatment of patients with major depressive disorder. J Sex Med. 2007; 4(4 Pt 1): 917929.
8. Ashton, AK, Rosen, RC. Accommodation to serotonin reuptake inhibitor-induced sexual dysfunction. J Sex Marital Ther. 1998; 24(3): 191192.
9. Delgado, PL, Brannan, SK, Mallinckrodt, CH, et al. Sexual functioning assessed in 4 double-blind placebo- and paroxetine-controlled trials of duloxetine for major depressive disorder. J Clin Psychiatry. 2005; 66(6): 686692.
10. Hu, XH, Bull, SA, Hunkeler, EM, et al. Incidence and duration of side effects and those rated as bothersome with selective serotonin reuptake inhibitor treatment for depression: patient report versus physician estimate. J Clin Psychiatry. 2004; 65(7): 959965.
11. Williams, VS, Baldwin, DS, Hogue, SL, Fehnel, SE, Hollis, KA, Edin, HM. Estimating the prevalence and impact of antidepressant-induced sexual dysfunction in 2 European countries: a cross-sectional patient survey. J Clin Psychiatry. 2006; 67(2): 204210.
12. Duenas, H, Lee, A, Brnabic, AJ, et al. Frequency of treatment-emergent sexual dysfunction and treatment effectiveness during SSRI or duloxetine therapy: 8-week data from a 6-month observational study. Int J Psychiatry Clin Pract. 2011; 15(2): 8090.
13. Pratt, L, Brody, D, Gu, Q. Antidepressant Use Among Persons Aged 12 and Over: United States, 2011–2014. NCHS Data Brief No. 283, August 2017. Hyattsville, MD: National Center for Health Statistics; 2017.
14. Chokka, PR, Hankey, JR. Assessment and management of sexual dysfunction in the context of depression. Ther Adv Psychopharmacol. 2018; 8(1): 1323.
15. Jacobsen, PL, Mahableshwarkar, AR, Chen, Y, Chrones, L, Clayton, AH. Effect of vortioxetine vs. escitalopram on sexual functioning in adults with well-treated major depressive disorder experiencing SSRI-induced sexual dysfunction. J Sex Med. 2015; 12(10): 20362048.
16. Rothschild, AJ. Selective serotonin reuptake inhibitor-induced sexual dysfunction: efficacy of a drug holiday. Am J Psychiatry. 1995; 152(10): 15141516.
17. Clayton, AH, Warnock, JK, Kornstein, SG, Pinkerton, R, Sheldon-Keller, A, McGarvey, EL. A placebo-controlled trial of bupropion SR as an antidote for selective serotonin reuptake inhibitor-induced sexual dysfunction. J Clin Psychiatry. 2004; 65(1): 6267.
18. Taylor, MJ, Rudkin, L, Bullemor-Day, P, Lubin, J, Chukwujekwu, C, Hawton, K. Strategies for managing sexual dysfunction induced by antidepressant medication. Cochrane Database Syst Rev. 2013; 2013(5): CD003382.
19. Bang-Andersen, B, Ruhland, T, Jorgensen, M, et al. Discovery of 1-2-(2, 4-dimethylphenylsulfanyl)phenyl.piperazine (Lu AA21004): a novel multimodal compound for the treatment of major depressive disorder. J Med Chem. 2011; 54(9): 32063221.
20. Westrich, L, Pehrson, A, Zhong, H, et al. In vitro and in vivo effects for the multimodal antidepressant vortioxetine (Lu AA21004) at human and rat targets. Int J Psychiatry Clin Pract. 2012; 16(S1): 47.
21. Trintellix package insert. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; 2016.
22. Baldwin, DS, Loft, H, Dragheim, M. A randomised, double-blind, placebo controlled, duloxetine-referenced, fixed-dose study of three dosages of Lu AA21004 in acute treatment of major depressive disorder (MDD). Eur Neuropsychopharmacol. 2012; 22(7): 482491.
23. Boulenger, JP, Loft, H, Olsen, CK. Efficacy and safety of vortioxetine (Lu AA21004), 15 and 20mg/day: a randomized, double-blind, placebo-controlled, duloxetine-referenced study in the acute treatment of adult patients with major depressive disorder. Int Clin Psychopharmacol. 2014; 29(3): 138149.
24. Henigsberg, N, Mahableshwarkar, AR, Jacobsen, P, Chen, Y, Thase, ME. A randomized, double-blind, placebo-controlled 8-week trial of the efficacy and tolerability of multiple doses of Lu AA21004 in adults with major depressive disorder. J Clin Psychiatry. 2012; 73(7): 953959.
25. Jain, R, Mahableshwarkar, AR, Jacobsen, P, Chen, Y, Thase, ME. A randomized, double-blind, placebo-controlled 6-wk trial of the efficacy and tolerability of 5 mg vortioxetine in adults with major depressive disorder. Int J Neuropsychopharmacol. 2013; 16(2): 313321.
26. Mahableshwarkar, AR, Jacobsen, PL, Chen, Y. A randomized, double-blind trial of 2.5 mg and 5 mg vortioxetine (Lu AA21004) versus placebo for 8 weeks in adults with major depressive disorder. Curr Med Res Opin. 2013; 29(3): 217226.
27. Jacobsen, PL, Mahableshwarkar, AR, Chen, Y, Chrones, L, Clayton, AH. effect of vortioxetine vs. escitalopram on sexual functioning in adults with well-treated major depressive disorder experiencing SSRI-induced sexual dysfunction. J Sex Med. 2015; 12(10): 20362048.
28. Guy, W. The Clinician Global Severity and Impression Scales: ECDEU Assessment Manual for Psychopharmacology. DHEW Publication no. 76–338. Rockville, MD: National Institute of Mental Health; 1976: 218222.
29. Keller, A, McGarvey, EL, Clayton, AH. Reliability and construct validity of the Changes in Sexual Functioning Questionnaire short-form (CSFQ-14). J Sex Marital Ther. 2006; 32(1): 4352.
30. Clayton, AH, Hamilton, DV. Female sexual dysfunction. Psychiatr Clin North Am. 2010; 33(2): 323338.
31. Bulloch, A, Williams, J, Lavorato, D, Patten, S. Recurrence of major depressive episodes is strongly dependent on the number of previous episodes. Depress Anxiety. 2014; 31(1): 7276.
32. Feldman, HA, Goldstein, I, Hatzichristou, DG, Krane, RJ, McKinlay, JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994; 151(1): 5461.
33. Clayton, AH, Gommoll, C, Chen, D, Nunez, R, Mathews, M. Sexual dysfunction during treatment of major depressive disorder with vilazodone, citalopram, or placebo: results from a phase IV clinical trial. Int Clin Psychopharmacol. 2015; 30(4): 216223.
34. Salazar, DE, Frackiewicz, EJ, Dockens, R, et al. Pharmacokinetics and tolerability of buspirone during oral administration to children and adolescents with anxiety disorder and normal healthy adults. J Clin Pharmacol. 2001; 41(12): 13511358.
35. Rickels, K, Athanasiou, M, Robinson, DS, Gibertini, M, Whalen, H, Reed, CR. Evidence for efficacy and tolerability of vilazodone in the treatment of major depressive disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009; 70(3): 326333.

Keywords

Type Description Title
PDF
Supplementary materials

Jacobsen et al. supplementary material
Jacobsen et al. supplementary material 1

 PDF (389 KB)
389 KB

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 (a1), George G. Nomikos (a1), Wei Zhong (a2), Andrew J. Cutler (a3), John Affinito (a1) and Anita Clayton (a4)...

Metrics

Full text views

Total number of HTML views: 0
Total number of PDF views: 0 *
Loading metrics...

Abstract views

Total abstract views: 0 *
Loading metrics...

* Views captured on Cambridge Core between <date>. This data will be updated every 24 hours.

Usage data cannot currently be displayed