BACKGROUND: The authors designed a randomized, double-blind, crossover study to assess the efficacy of sertraline in the treatment of premenstrual dysphoric disorder (PMDD) when given only during the luteal phase of the menstrual cycle. METHOD:Thirty-one subjects were selected for a 7-month study period that included an initial 2 months of screening, 2 months of treatment withplacebo 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 daily reports using the Calendar of Premenstrual Experience (COPE). For each study phase, premenstrual COPE scores (7 days prior to menses) were 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. RESULTS: Analysis of COPE results during the treatment periods of the luteal phase showed a significant treatment effect, with higher scores during 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 reuptake inhibitor used only during the luteal phase. The authors point out the importance of this finding both in terms of economic cost of patients as well as how it may add to the growing understanding of the etiology of PMDD.
RCT Entities:
BACKGROUND: The authors designed a randomized, double-blind, crossover study to assess the efficacy of sertraline in the treatment of premenstrual dysphoric disorder (PMDD) when given only during the luteal phase of the menstrual cycle. METHOD: Thirty-one subjects were selected for a 7-month study period that included an initial 2 months of screening, 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 daily reports using the Calendar of Premenstrual Experience (COPE). For each study phase, premenstrual COPE scores (7 days prior to menses) were 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. RESULTS: Analysis of COPE results during the treatment periods of the luteal phase showed a significant treatment effect, with higher scores during 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 reuptake inhibitor used only during the luteal phase. The authors point out the importance of this finding both in terms of economic cost of patients as well as how it may add to the growing understanding of the etiology of PMDD.
Authors: Kimberly A Yonkers; Susan G Kornstein; Ralitza Gueorguieva; Brian Merry; Kari Van Steenburgh; Margaret Altemus Journal: JAMA Psychiatry Date: 2015-10 Impact factor: 21.596