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


METHODS
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.


METHODS
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.


METHODS
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.


CONCLUSIONS
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.
Nurnberg
H George
HG
Department of Psychiatry, Health Sciences Center,University of New Mexico School of Medicine, 2400 Tucker NE, Albuquerque, NM 87131-5288, USA. geon@unm.edu
Hensley
Paula L
PL
Gelenberg
Alan J
AJ
Fava
Maurizio
M
Lauriello
John
J
Paine
Susan
S
D000328:Adult; D000928:Antidepressive Agents / Q000009:adverse effects*; D003865:Major Depressive Disorder / Q000188:drug therapy; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000139:chemically induced* / Q000188:drug therapy*; D006801:Humans; D008297:Male; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D010879:Piperazines / Q000627:therapeutic use*; D011446:Prospective Studies; D011687:Purines; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects*; D000068677:Sildenafil Citrate; D013450:Sulfones; D014665:Vasodilator Agents / Q000627:therapeutic use*
D000928:Antidepressive Agents; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D017367:Selective Serotonin Reuptake Inhibitors; D000068677:Sildenafil Citrate; D013450:Sulfones; D014665:Vasodilator Agents