Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Original Article
  • Published:

Open-label sildenafil treatment of partial and non-responders to double-blind treatment in men with antidepressant-associated sexual dysfunction

International Journal of Impotence Research volume 19, pages 167–175 (2007)Cite this article

Abstract

Fifty partial and non-responders (Clinical Global Impression-Sexual Function (CGI-SF) score>2), out of 76 men who completed a 6-week, double-blind, placebo-controlled trial of sildenafil treatment for serotonergic antidepressant–associated sexual dysfunction, were eligible for an additional 6-week trial of open-label sildenafil (50 mg adjustable to 100 mg) under the same protocol, with blind maintained to initial assignment. Participation (double-blind and open-label) required major depressive disorder in remission (MDD-R) and continuing antidepressant medication. Forty-three entered open-label study: 16/17 initially randomized to sildenafil (sildenafil/sildenafil) and 27/33 initially randomized to placebo (placebo/sildenafil). Thirty-five of 43 (81%) achieved full response (CGI-SF⩽2): placebo/sildenafil 23/27 (85%); sildenafil/sildenafil 12/16 (75%); P<0.0001 for changes and P=0.4 between groups. Secondary measures of erectile function and overall satisfaction improved in both groups (P<0.03). Hamilton Depression Rating Scale scores improved (placebo/sildenafil; P⩽0.05) or remained stable (sildenafil/sildenafil). In men with MDD-R who maintained antidepressant adherence, 81% of double-blind partial and non-responders treated with open-label sildenafil responded fully.

This is a preview of subscription content, access via your institution

Access options

Buy this article

  • Purchase on Springer Link
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

Figure 1

Similar content being viewed by others

References

  1. Woodwell DA . National Ambulatory Care Medical Survey: 1997. Adv Data 1999; 20: 1–28.

    Google Scholar 

  2. Agency for Healthcare Policy Research. Evidence Report on Treatment of Depression – Newer Pharmacotherapies. San Antonio Evidence-Based Practice Center. AHCPR, Evidence-Based Practice Centers: Washington, DC, 1999.

  3. American Psychiatric Association. Practice guideline for the treatment of patients with major depressive disorder. Am J Psychiatry 2000; 157 (Suppl): 1–45.

  4. Bull SA, Hu XH, Hunkeler EM, Lee JY, Ming EE, Markson LE et al. Discontinuation of use and switching of antidepressants: influence of patient–physician communication. JAMA 2002; 288: 1403–1409.

    Article  Google Scholar 

  5. Nurnberg HG . Managing treatment-emergent sexual dysfunction associated with serotonergic antidepressants: before and after sildenafil. J Psychiatr Pract 2001; 7: 92–108.

    CAS  PubMed  Google Scholar 

  6. Anderson IM, Nutt DJ, Deakin JF . Evidence-based guidelines for treating depressive disorders with antidepressants: a revision of the 1993 British Association for Psychopharmacology guidelines. British Association for Psychopharmacology. J Psychopharmacol 2000; 14: 3–20.

    Article  CAS  Google Scholar 

  7. Hu XH, Bull SA, Hunkeler EM, Ming E, Lee JY, Fireman B 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: 959–965.

    Article  CAS  Google Scholar 

  8. Clayton AH, Pradko JF, Croft HA, Montano CB, Leadbetter RA, Bolden-Watson C et al. Prevalence of sexual dysfunction among newer antidepressants. J Clin Psychiatry 2002; 63: 357–366.

    Article  Google Scholar 

  9. Zimmerman M, Posternak M, Friedman M, Attiullah N, Baymiller S, Boland R et al. Which factors influence psychiatrists’ selection of antidepressants? Am J Psychiatry 2004; 161: 1285–1289.

    Article  Google Scholar 

  10. Bloom BS . Daily regimen and compliance with treatment. BMJ 2001; 323: 647.

    Article  CAS  Google Scholar 

  11. Rudkin L, Taylor MJ, Hawton K . Strategies for managing sexual dysfunction induced by antidepressant medication. Cochrane Database Syst Rev 2004 October 18: CD003382.

    Google Scholar 

  12. Nurnberg HG, Hensley PL, Gelenberg AJ, Fava M, Lauriello J, Paine S . Treatment of antidepressant-associated sexual dysfunction with sildenafil: a randomized controlled trial. JAMA 2003; 289: 56–64.

    Article  CAS  Google Scholar 

  13. Nurnberg HG, Seidman SN, Gelenberg AJ, Fava M, Rosen R, Shabsigh R . Depression, antidepressant therapies, and erectile dysfunction: clinical trials of sildenafil citrate (Viagra®) in treated and untreated patients with depression. Urology 2002; 60 (Suppl 2B): 58–66.

    Article  Google Scholar 

  14. Fava M, Nurnberg HG, Seidman SN, Holloway W, Nicholas S, Tseng L-J et al. Efficacy and safety of sildenafil in men with serotonergic antidepressant-associated erectile dysfunction: results from a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry 2006; 67: 240–246.

    Article  CAS  Google Scholar 

  15. Seidman SN, Roose SP, Menza MA, Shabsigh R, Rosen RC . Treatment of erectile dysfunction in men with depressive symptoms: results of a placebo-controlled trial with sildenafil citrate. Am J Psychiatry 2001; 158: 1623–1630.

    Article  CAS  Google Scholar 

  16. Webster LJ, Michelakis ED, Davis T, Archer SL . Use of sildenafil for safe improvement of erectile function and quality of life in men with New York Heart Association classes II and III congestive heart failure: a prospective, placebo-controlled, double-blind crossover trial. Arch Intern Med 2004; 164: 514–520.

    Article  CAS  Google Scholar 

  17. Tignol J, Furlan PM, Gomez-Beneyto M, Opsomer R, Schreiber W, Sweeney M et al. Efficacy of sildenafil citrate (Viagra) for the treatment of erectile dysfunction in men in remission from depression. Int Clin Psychopharmacol 2004; 19: 191–199.

    Article  Google Scholar 

  18. Nurnberg HG, Gelenberg A, Hargreave TB, Harrison WM, Siegel RL, Smith MD . Efficacy of sildenafil citrate for the treatment of erectile dysfunction in men taking serotonin reuptake inhibitors. Am J Psychiatry 2001; 158: 1926–1928.

    Article  CAS  Google Scholar 

  19. Brock G, Nehra A, Lipshultz L, Gleave M, Seger M, Padma-Nathan H et al. Influence of vardenafil on erectile dysfunction (ED) and depressive symptoms post radical prostatectomy. Int J Impot Res 2002; 14 (Suppl 1): S97–S98.

    Google Scholar 

  20. Rosen R, Montorsi F, Assalian P, Rodriguez-Vela L, Porto R, Bangerter K et al. Efficacy and tolerability of vardenafil in men with mild major depressive disorder and erectile dysfunction: the depression related improvement with vardenafil for erectile response (DRIVER) study. Eur Urol (Suppl) 2004; 3: 235.

    Article  Google Scholar 

  21. Guy W . ECDEU Assessment Manual for Psychopharmacology. National Institute of Mental Health, US Department of Health, Education, and Welfare: Washington, DC, 1976.

    Google Scholar 

  22. Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A . The International Index of Erectile Function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 1997; 49: 822–830.

    Article  CAS  Google Scholar 

  23. Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Peña BM . Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res 1999; 11: 319–326.

    Article  CAS  Google Scholar 

  24. McGahuey CA, Gelenberg AJ, Laukes CA, Moreno FA, Delgado PL, McKnight KM et al. The Arizona Sexual Experience Scale (ASEX): reliability and validity. J Sex Marital Ther 2000; 26: 25–40.

    Article  CAS  Google Scholar 

  25. Labbate LA, Lare SB . Sexual dysfunction in male psychiatric outpatients: validity of the Massachusetts General Hospital Sexual Functioning Questionnaire. Psychother Psychosom 2001; 70: 221–225.

    Article  CAS  Google Scholar 

  26. Nurnberg HG, Gelenberg A, Fava M, Hensley PL, Lauriello J, Paine S . The sexual function inventory: a screening instrument for antidepressant-associated sexual dysfunction. Presented at American Psychiatric Association Annual Meeting; May 7, 2001; New Orleans, LA.

  27. Hamilton MA . A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23: 56–62.

    Article  CAS  Google Scholar 

  28. Barsky AJ, Saintfort R, Rogers MP, Borus JF . Nonspecific medication side effects and the nocebo phenomenon. JAMA 2002; 287: 622–627.

    Article  Google Scholar 

  29. McCullough AR, Barada JH, Fawzy A, Guay AT, Hatzichristou D . Achieving treatment optimization with sildenafil citrate (Viagra®) in patients with erectile dysfunction. Urology 2002; 60 (Suppl 2B): 28–38.

    Article  Google Scholar 

  30. Leuchter AF, Cook IA, Witte EA, Morgan M, Abrams M . Changes in brain function of depressed subjects during treatment with placebo. Am J Psychiatry 2002; 159: 122–129.

    Article  Google Scholar 

  31. Lydiard RB, Perera P, Batzar E, Clary CM . From the bench to the trench: a comparison of sertraline treatment of major depression in clinical and research patient samples. Prim Care Companion J Clin Psychiatry 1999; 1: 154–162.

    Article  Google Scholar 

  32. Balon R . Fluvoxamine-induced erectile dysfunction responding to sildenafil. J Sex Marital Ther 1998; 24: 313–317.

    Article  CAS  Google Scholar 

  33. Ashton AK, Bennett RG . Sildenafil treatment of serotonin reuptake inhibitor-induced sexual dysfunction. J Clin Psychiatry 1999; 60: 194–195.

    Article  CAS  Google Scholar 

  34. Schaller JL, Behar D . Sildenafil citrate for SSRI-induced sexual side effects. Am J Psychiatry 1999; 156: 156–157.

    Article  CAS  Google Scholar 

  35. Gupta S, Droney T, Masand P, Ashton AK . SSRI-induced sexual dysfunction treated with sildenafil. Depress Anxiety 1999; 9: 180–182.

    Article  CAS  Google Scholar 

  36. Nurnberg H, Lauriello J, Hensley P, Parker L, Keith S . Sildenafil for iatrogenic serotonergic antidepressant medication-induced sexual dysfunction in 4 patients. J Clin Psychiatry 1999; 60: 33–35.

    Article  CAS  Google Scholar 

  37. Fava M, Rankin MA, Alpert JE, Nierenberg AA, Worthington JJ . An open trial of oral sildenafil in antidepressant-induced sexual dysfunction. Psychother Psychosom 1998; 67: 328–331.

    Article  CAS  Google Scholar 

  38. Seidman SN, Pesce VC, Roose SP . High-dose sildenafil citrate for selective serotonin reuptake inhibitor-associated ejaculatory delay: open clinical trial. J Clin Psychiatry 2003; 64: 721–725.

    Article  CAS  Google Scholar 

  39. Segraves RT, Stevenson R, Lee J, Walker D, Wang C, Dickson R . Tadalafil treatment of ED in men on antidepressants. Presented at: Proceedings of the 157th Annual Meeting of the American Psychiatric Association; 2004; New York, NY.

  40. Nurnberg HG, Segraves T, Levine S, Frey N, Natanegara F, Wong D et al. Tadalafil is efficacious for treatment of erectile dysfunction in a population of patients with comorbid depression. J Sex Med 2004; 2 (Suppl 1): 45.

    Google Scholar 

Download references

Acknowledgements

This study was supported by an independent investigator-initiated grant from Pfizer Inc., New York, NY. Editorial support was provided by Deborah M Campoli-Richards.

Author information

Authors and Affiliations

  1. Department of Psychiatry, University of New Mexico School of Medicine, Albuquerque, NM, USA

    H G Nurnberg, P L Hensley & S Paine

  2. Massachusetts General Hospital, Depression Clinical and Research Program, Boston, MA, USA

    M Fava

  3. Department of Psychiatry, Arizona Health Sciences Center, Tucson, AZ, USA

    A J Gelenberg

Authors
  1. H G Nurnberg
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. M Fava
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. A J Gelenberg
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. P L Hensley
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. S Paine
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to H G Nurnberg.

Additional information

Previous presentations: 157th Annual Meeting of the American Psychiatric Association, New York, NY, May 1–6, 2004.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Nurnberg, H., Fava, M., Gelenberg, A. et al. Open-label sildenafil treatment of partial and non-responders to double-blind treatment in men with antidepressant-associated sexual dysfunction. Int J Impot Res 19, 167–175 (2007). https://doi.org/10.1038/sj.ijir.3901502

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/sj.ijir.3901502

Keywords

This article is cited by

Search

Advanced search

Quick links