TREATMENT OF PREMENSTRUAL DYSPHORIC DISORDER WITH SERTRALINE DURING THE LUTEAL-PHASE - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CROSSOVER TRIAL

Background: The authors designed a randomized, double-blind, crossover study to assess the efficacy of sertraline in the treatment of premen strual dysphoric disorder (PMDD) when given only during the luteal pha se of the menstrual cycle. Method: Thirty-one subjects were selected f or a 7-month study period that included an initial 2 months of screeni ng, 2 months of treatment with placebo or sertraline, 1 washout month, and 2 months of crossover treatment with either placebo or sertraline . Eleven subjects completed the study. Symptoms were monitored with da ily reports using the Calendar of Premenstrual Experience (COPE). For each study phase, premenstrual COPE scores (7 days prior to menses) we re examined using repeated measures analysis of variance. Scores were logarithmically transformed. Comparison of baseline scores between the luteal and follicular phases was examined using the paired t test. Re sults: Analysis of COPE results during the treatment periods of the lu teal phase showed a significant treatment effect, with higher scores d uring the placebo cycles compared with the sertraline-treated cycles ( p =.0052 behavioral, p =.014 physical). Conclusion: This study is the first to demonstrate a significant response to a serotonin selective r euptake inhibitor used only during the luteal phase. The authors point out the importance of this finding both in terms of economic cost to patients as well as how it may add to the growing understanding of the etiology of PMDD.