Severe premenstrual syndrome (PMS) is a chronic and complex mood disorder that involves a constellation of mood, behavioral and physical symptoms linked to the menstrual cycle with sufficient severity to disrupt functioning for as much as several weeks each menstrual cycle. Five to ten percent of reproductive-age women meet strict diagnostic criteria, but up to 40 percent seek medical treatment for this disorder. The efficacy of serotonin reuptake inhibiting antidepressants (SKIs) is clearly demonstrated for severe forms of PMS in short-term treatment trials. However, there are no long-term studies of severe PMS, and it is not known how long medication should be continued following symptom relief, to what extent and how rapidly symptoms return after stopping medication, or whether there is any additional improvement with long-term treatment. The proposed study compares short-term treatment (4 months) and long-term treatment (12 months) of severe PMS with the SRI sertraline and double-blind switch to placebo to study the effects of discontinuing medication.
The aims are as follows: 1) Compare between short- and long-term treatment the percent of subjects relapsed within 6 months after discontinuing medication; 2) Determine the time to relapse after discontinuing medication and compare the time between the short- and long-term treatment groups; 3) Compare symptom levels while on drug between the short- and long-term treatment groups; 4) Compare the trend over time in symptom scores during the placebo period between the short- and long-term treatment groups. It is important to systematically examine these questions in order to minimize the risks and costs of medication if it is not needed or to support using medication if it is needed to prevent relapse and its attendant distress and disruptions of daily functioning for the large numbers of women who suffer from the disorder.
| 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 |
Showing the most recent 10 out of 28 publications
