High-dose sildenafil citrate for selective serotonin reuptake inhibitor-associated ejaculatory delay: open clinical trial.
BACKGROUND
Selective serotonin reuptake inhibitor (SSRI)-induced ejaculatory delay is a common problem that has no treatment with established efficacy. Sildenafil citrate is effective for erectile dysfunction and appears to be safe at doses up to 200 mg.


METHODS
We enrolled men who were in remission from depression according to DSM-IV criteria and who reported that they had developed new-onset ejaculatory delay in the setting of SSRI treatment. Enrolled patients were instructed to use 25 mg of sildenafil 1 hour prior to sexual activity on at least 2 occasions. If this was not effective for the ejaculatory delay, they were instructed to increase the dose progressively up to a maximum of 200 mg. We compared baseline sexual functioning to 2 phases of open treatment: low-dose phase (sildenafil 25-100 mg) and high-dose phase (sildenafil 150-200 mg). The primary outcome measure was a modified, self-report Clinical Global Impressions (CGI) scale that was specific for erectile (CGI-EF) and ejaculatory (CGI-EJF) aspects of sexual function.


RESULTS
Twenty-one men (mean age = 56 years) with major depressive disorder (MDD) in remission and SSRI-associated ejaculatory delay enrolled in the study and received sildenafil. At baseline, 14 of 21(67%) had comorbid erectile dysfunction. At the low-dose phase follow-up assessment, 12 of 14 achieved full erectile dysfunction remission, and 4 of 21 achieved ejaculatory delay remission. Sixteen patients with persistent ejaculatory delay were eligible for the high-dose phase: 5 withdrew from the study, 4 increased to a maximum dose of 150 mg, and 6 increased to a maximum dose of 200 mg. The 1 patient who had clinically significant erectile dysfunction and ejaculatory delay reported improvement of both conditions after the high-dose phase. Of the 10 patients who had ejaculatory delay without significant erectile dysfunction and who chose to take high-dose sildenafil, 9 reported a significant clinical improvement in ejaculatory delay (CGI-EJF improvement score of 1 or 2) and 7 achieved full remission (CGI-EJF severity score of 1 or 2 and CGI-EJF improvement score of 1 or 2).


CONCLUSIONS
In this open clinical trial with men who had SSRI-induced ejaculatory delay, high-dose sildenafil appeared to be effective in reducing ejaculatory latency.
Seidman
Stuart N
SN
Department of Psychiatry, College of Physicians and Surgeons of Columbia University, and the New York State Psychiatric Institute, New York, NY 10032, USA. Sns5@columbia.edu
Pesce
Vanessa C
VC
Roose
Steven P
SP
D000328:Adult; D000368:Aged; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004542:Ejaculation / Q000187:drug effects*; D007172:Erectile Dysfunction / Q000139:chemically induced / Q000188:drug therapy / Q000523:psychology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D010879:Piperazines / Q000008:administration & dosage / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D011687:Purines; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D020018:Sexual Dysfunctions, Psychological / Q000139:chemically induced* / Q000188:drug therapy*; D000068677:Sildenafil Citrate; D013450:Sulfones; D016896:Treatment Outcome
D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D017367:Selective Serotonin Reuptake Inhibitors; D000068677:Sildenafil Citrate; D013450:Sulfones