Reemergence of Sexual Dysfunction in Patients With Major Depressive Disorder: Double-Blind Comparison of Nefazodone and Sertraline
J Clin Psychiatry 2001;62(1):24-29
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Background: Several different classes of
antidepressants have been associated with sexual adverse effects.
This double-blind, randomized trial compared the effects of
nefazodone and sertraline on reemergence of sexual dysfunction in
depressed patients who had experienced sexual dysfunction as a
result of sertraline treatment. Depressive symptoms were also
Method: One hundred five patients with DSM-III-R
major depressive episode who were experiencing sexual dysfunction
attributable to sertraline (100 mg/day) were screened for entry.
Eligible patients entered a 1-week washout period that was
followed by a 7- to 10-day single-blind placebo phase. Patients
without symptoms of sexual dysfunction at the end of the
single-blind placebo phase were randomly assigned to receive
double-blind treatment with either nefazodone (400 mg/day) or
sertraline (100 mg/day) for 8 weeks.
Results: Nearly 3 times more sertraline-treated
patients (76%; 25/33) experienced reemergence of sexual
dysfunction (ejaculatory and/or orgasmic difficulty) than did
nefazodone-treated patients (26%; 10/39) (p < .001). In
addition, patients treated with nefazodone were more satisfied
with their sexual functioning than were patients treated with
sertraline. Both treatment groups demonstrated a similar and
sustained improvement in depressive symptoms. Both drugs were
well tolerated, and the overall incidence of adverse reactions
was similar for both treatment groups; however, 9
sertraline-treated patients (26%) discontinued because of adverse
events compared with 5 nefazodone-treated patients (12%). Of the
patients discontinuing therapy for adverse events, 5 of the
sertraline-treated patients did so because of sexual dysfunction
reported as an adverse event, whereas only 1 of the
nefazodone-treated patients discontinued therapy secondary to
Conclusion: In this sample of patients with
major depression who had recovered from sexual dysfunction
induced by treatment with sertraline, nefazodone treatment
resulted in significantly less reemergence of sexual dysfunction
than did renewed treatment with sertraline and provided continued