Premenstrual syndrome (PMS) is a complex, chronic, menstrually-related disorder, which is reported at severe levels that impairs functioning by 5-10 percent of reproductive-age women. Severe PMS is associated with diminished productivity, lost work time in the prime years of life, and troubled interpersonal relationships, particularly with the partner and children. Only in recent years, and resulting from these studies and other research, has there been scientific information on the efficacy and safety of treatments and investigation of the etiology of PMS. The investigators conceptualize PMS as mood and behavioral changes that derive from central effects, possibly an altered central nervous system (CNS) sensitivity involving changes of gonadal-adrenal steroids. Building on findings of serotonergic involvement in PMS symptoms, the investigators propose to complete and extend studies of the efficacy and safety of serotonergic antidepressant treatment for PMS.
The aims of this competing renewal application are to: 1) complete a large clinical study comparing the efficacy of a serotonergic and a noradrenergic antidepressant with a sample size sufficient for definitive results; 2) conduct a randomized, double-blind, placebo-controlled study of intermittent dosing with sertraline administered in the symptomatic premenstrual phase compared to daily dosing; and 3) examine the impact of PMS on functioning, productivity, health care utilization and quality of life before and after medical treatment in aim #1.
| Freeman, Ellen W; Halberstadt, Steffanie M; Rickels, Karl et al. (2011) Core symptoms that discriminate premenstrual syndrome. J Womens Health (Larchmt) 20:29-35 |
| Freeman, Ellen W; Sammel, Mary D; Lin, Hui et al. (2011) Clinical subtypes of premenstrual syndrome and responses to sertraline treatment. Obstet Gynecol 118:1293-300 |
| Gracia, Clarisa R; Freeman, Ellen W; Sammel, Mary D et al. (2009) Allopregnanolone levels before and after selective serotonin reuptake inhibitor treatment of premenstrual symptoms. J Clin Psychopharmacol 29:403-5 |
| Freeman, Ellen W; Rickels, Karl; Sammel, Mary D et al. (2009) Time to relapse after short- or long-term treatment of severe premenstrual syndrome with sertraline. Arch Gen Psychiatry 66:537-44 |
| Freeman, Ellen W; Rickels, Karl; Sondheimer, Steven J et al. (2004) Continuous or intermittent dosing with sertraline for patients with severe premenstrual syndrome or premenstrual dysphoric disorder. Am J Psychiatry 161:343-51 |
| Freeman, Ellen W; Sondheimer, Steven J; Rickels, Karl et al. (2004) A pilot naturalistic follow-up of extended sertraline treatment for severe premenstrual syndrome. J Clin Psychopharmacol 24:351-3 |
| Freeman, Ellen W; Frye, Cheryl A; Rickels, Karl et al. (2002) Allopregnanolone levels and symptom improvement in severe premenstrual syndrome. J Clin Psychopharmacol 22:516-20 |
| Rickels, K; Freeman, E W (2000) Prior benzodiazepine exposure and benzodiazepine treatment outcome. J Clin Psychiatry 61:409-13 |
| Freeman, E W; Sondheimer, S J; Polansky, M et al. (2000) Predictors of response to sertraline treatment of severe premenstrual syndromes. J Clin Psychiatry 61:579-84 |
| Freeman, E W; Rickels, K; Arredondo, F et al. (1999) Full- or half-cycle treatment of severe premenstrual syndrome with a serotonergic antidepressant. J Clin Psychopharmacol 19:3-8 |
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