Objective: Premenstrual dysphoric disorder (PMDD) is a complex clinical syndrome that is notoriously difficult to treat. The purpose of the present study was to provide preliminary data on the effectiveness of duloxetine in PMDD.
Research design and methods: Fifty-five women with PMDD were treated with a 60 mg/day dosage of duloxetine for two menstrual cycles. Responses were assessed at first and second treatment cycle.
Main outcome measures: Outcome measures included a visual analogue scale, the Zung Self-rating Scale for Depression, the Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale and the Clinical Global Impressions Scale.
Results: Fifty patients completed the trial. All had significant improvement of depression and anxiety and response, defined as a 50% decrease in daily symptom scores, occurred in 39 (78%) patients. The effects of active treatment were marked by the first active cycle of menstruation.
Conclusions: Duloxetine 60 mg/day was effective in reducing PMDD symptoms and generally well tolerated. Limitations of the study were open-label design and lack of placebo control. However, the results appeared to be strong and consistent across measures. Adverse events (nausea, insomnia, poor appetite) were low. Further studies are needed to confirm these results.