Treatment of antidepressant-associated sexual dysfunction with sildenafil: a randomized controlled trial

JAMA. 2003 Jan 1;289(1):56-64. doi: 10.1001/jama.289.1.56.

Abstract

Context: Sexual dysfunction is a common adverse effect of antidepressants that frequently results in treatment noncompliance.

Objective: To assess the efficacy of sildenafil citrate in men with sexual dysfunction associated with the use of selective and nonselective serotonin reuptake inhibitor (SRI) antidepressants.

Design, setting, and patients: Prospective, parallel-group, randomized, double-blind, placebo-controlled trial conducted between November 1, 2000, and January 1, 2001, at 3 US university medical centers among 90 male outpatients (mean [SD] age, 45 [8] years) with major depression in remission and sexual dysfunction associated with SRI antidepressant treatment.

Intervention: Patients were randomly assigned to take sildenafil (n = 45) or placebo (n = 45) at a flexible dose starting at 50 mg and adjustable to 100 mg before sexual activity for 6 weeks.

Main outcome measures: The primary outcome measure was score on the Clinical Global Impression-Sexual Function (CGI-SF); secondary measures were scores on the International Index of Erectile Function, Arizona Sexual Experience Scale, Massachusetts General Hospital-Sexual Functioning Questionnaire, and Hamilton Rating Scale for Depression (HAM-D).

Results: Among the 90 randomized patients, 93% (83/89) of patients treated per protocol took at least 1 dose of study drug and 85% (76/89) completed week 6 end-point assessments with last observation carried forward analyses. At a CGI-SF score of 2 or lower, 54.5% (24/44) of sildenafil compared with 4.4% (2/45) of placebo patients were much or very much improved (P<.001). Erectile function, arousal, ejaculation, orgasm, and overall satisfaction domain measures improved significantly in sildenafil compared with placebo patients. Mean depression scores remained consistent with remission (HAM-D score < or =10) in both groups for the study duration.

Conclusion: In our study, sildenafil effectively improved erectile function and other aspects of sexual function in men with sexual dysfunction associated with the use of SRI antidepressants. These improvements may allow patients to maintain adherence with effective antidepressant treatment.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antidepressive Agents / adverse effects*
  • Depressive Disorder, Major / drug therapy
  • Double-Blind Method
  • Erectile Dysfunction / chemically induced*
  • Erectile Dysfunction / drug therapy*
  • Humans
  • Male
  • Phosphodiesterase Inhibitors / therapeutic use*
  • Piperazines / therapeutic use*
  • Prospective Studies
  • Purines
  • Serotonin Uptake Inhibitors / adverse effects*
  • Sildenafil Citrate
  • Sulfones
  • Vasodilator Agents / therapeutic use*

Substances

  • Antidepressive Agents
  • Phosphodiesterase Inhibitors
  • Piperazines
  • Purines
  • Serotonin Uptake Inhibitors
  • Sulfones
  • Vasodilator Agents
  • Sildenafil Citrate