High-Dose Sildenafil Citrate for Selective Serotonin Reuptake Inhibitor–Associated Ejaculatory Delay: Open Clinical Trial
J Clin Psychiatry 2003;64(6):721-725
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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.
Method: 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).
Conclusion: In this open clinical trial with men
who had SSRI-induced ejaculatory delay, high-dose sildenafil
appeared to be effective in reducing ejaculatory latency.