A Placebo-Controlled, Crossover Trial of Granisetron in SRI-Induced Sexual Dysfunction
J Clin Psychiatry 2001;62(6):469-473
© Copyright 2016 Physicians Postgraduate Press, Inc.
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Background: Sexual side effects are commonly
associated with serotonin reuptake inhibitor (SRI) therapy. The
mechanism underlying SRI-induced sexual dysfunction has been
hypothesized to be mediated by direct serotonergic effects.
Evidence from open-label reports suggests that cyproheptadine,
nefazodone, mirtazapine, and mianserin, which block one or more
serotonin receptors, may reverse sexual side effects. The current
study was a prospective, randomized, crossover trial comparing
granisetron, a serotonin-3 antagonist, with placebo in
outpatients who developed sexual dysfunction during SRI
Method: Thirty-one outpatients who were
currently experiencing sexual dysfunction associated with SRIs
were randomly assigned to double-blind treatment with granisetron
(1-1.5 mg) or placebo for use 1 to 2 hours prior to sexual
activity. Patients rated sexual symptoms after each trial using
the Sexual Side Effect Scale (SSES). After 4 trials of the
medication, patients crossed over to the other treatment for 4
Results: Twenty patients received at least 1
dose of placebo and granisetron. Analysis by repeated-measures
analysis of variance showed no significant effects of granisetron
relative to placebo. Significant improvement between baseline and
treatment-phase SSES scores was observed for both granisetron (p
= .0004) and placebo (p = .0081). The study medication was
generally well tolerated.
Conclusion: The results of this study do not
support the efficacy of granisetron (1-2 mg) in the treatment of
SRI-associated sexual side effects. A significant placebo
response may be associated with the treatment of SRI-induced