FLUVOXAMINE FOR PREMENSTRUAL DYSPHORIC DISORDER - A PILOT-STUDY

Background: Serotonergic agents appear to be effective treatments for premenstrual symptoms in a number of small trials. The purpose of this open-label treatment study was to collect pilot information on the ef ficacy of fluvoxamine for premenstrual dysphoric disorder (PDD). Metho d: Twelve women who sought medical treatment for premenstrual symptoms were evaluated. The main outcome measure was the premenstrual score f rom daily symptom reports (DSRs) maintained by the subjects. After a 2 -month screening period, 10 subjects who met DSM-IV criteria for PDD w ere treated with fluvoxamine taken daily for two menstrual cycles. The mean dose at 4 weeks was 85 mg/day; at 8 weeks, all subjects took 100 mg/day. Results: The mean premenstrual DSR scores improved at 4 weeks from the pretreatment baseline (paired t test, p < .0008) and remaine d improved at 8 weeks at approximately the same level (p < .003). Symp toms with the greatest improvement (p < .003, significant with the Bon ferroni adjustment) were irritability, anxiety, feeling out of control , and decreased interest in usual activity, Sixty percent (6/10) of th e subjects reported at least a 50% reduction in the DSR scores, a cons ervative clinical definition of improvement. The mean premenstrual Ham ilton Rating Scale for Depression scores decreased from 19 at the pret reatment baseline to 9 at the 4-week evaluation. The main side effects were insomnia (N = 6), fatigue (N = 4), dry mouth (N = 4), and nausea (N = 3) acid were generally mild and transient. Conclusion: These pro mising pilot data show the importance of a controlled trial over a lon ger time period to provide definitive information on the efficacy of f luvoxamine for premenstrual dysphoric disorder.