Treating stress incontinent women with duloxetine does not induce mood elevation.

Duloxetine, a potent and balanced dual reuptake inhibitor of serotonin and norepinephrine, is currently under investigation for the treatment of stress urinary incontinence (SUI) in women and the treatment of depression in men and women. This review evaluates the risk of mood elevation in women treated with duloxetine for SUI. Treatment-emergent adverse events were collected from 1913 women aged 22-83 in 4 double-blind, 12-week, placebo-controlled SUI studies and from 2161 women aged 20-87 in 4 open-label, long-term SUI studies. Active treatment was 40 mg of duloxetine twice daily (BID). Women currently in treatment for depression were excluded. Reports of mood elevation were obtained using non-probing questions, and were recorded regardless of perceived causality. In both the placebo-controlled and the open-label studies, reports of treatment-emergent elevated moods were rare. In the placebo-controlled studies, one case of mania and one case of euphoria were reported in the duloxetine-treated group; however, this was paralleled by two similar reports in the placebo-treated group. In the open-label studies, there were five occurrences of symptoms suggestive of mood elevation, but no cases of mania or hypomania were reported. No women discontinued the study due to treatment-emergent mood elevation. These data suggest that treatment with duloxetine does not induce mood elevation in stress incontinent women.

Lars Viktrup, MD, PhD, David Perahia, MD, BSc (Hons), MRC-Psych2, Richard C. Bump, MD, and Andre Tylee, MD. Lilly Research Laboratories, Eli Lilly Corporate Center, Indianapolis. IN. Lilly Research Center, Windlesham, Surrey, UK. The Gordon Hospital, London, UK. Institute of Psychiatry, London, UK.