The proposed project is an outgrowth of the rapidly growing demand for medical treatment of premenstrual symptoms from women who feel that these symptoms are incapacitating. A conservative estimate that premenstrual symptoms are severe in 10 percent of females of reproductive age in the U.S. means that the problem touches large numbers of women. Treatment is often at considerable expense and inconvenience; physicians lack diagnostic criteria and controlled evaluation of treatment responses. At this time, there are no scientific data that clearly support contentions of treatment effectiveness.
The specific aims of the proposed project are to (1) evaluate the efficacy of pyridoxine (Vitamin B6) for relief of premenstrual symptoms; (2) evaluate the efficacy of progesterone for relief of premenstrual symptoms; (3) determine which symptoms or symptom clusters are most likely to respond to these treatments and the relationships of intensity and timing of symptoms with treatment responses; (4) identify patient groups that are appropriately and inappropriately treated with these medications; and (5) report the safety of these medications for the dosages and time period of the study. At least 264 women will enter the treatment sequence in a double-blind crossover design. Phase I compares pyridoxine and placebo and also serves as a """"""""washout"""""""" of placebo response; Phase II compares progesterone and placebo; Phase III evaluates stability of improvement for six additional menstrual cycles. Specific menstrual symptoms, intensity and timing will be assessed prior to treatment, on Day 25 (+ or - 4) each menstrual cycle during the study with an evaluation of symptom factors also on Day 9 (+ or - 4). Measures are at 10 time points using objective self-assessment instruments, daily symptom recordings, physician and counselor ratings. Descriptive and multivariate statistical methods are employed. Information from the study will provide guidelines for medical management of premenstrual symptoms: e.g. whether pyridoxine and progesterone are more effective than placebo; which symptoms respond to these treatments. It will increase diagnostic information on the subgroups of syndromes within the broad range of premenstrual symptoms.
| 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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