Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder
Premenstrual Syndrome
About this trial
This is an interventional treatment trial for Premenstrual Syndrome
Eligibility Criteria
Inclusion Criteria: DSM-IV criteria for Premenstrual syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD) For a diagnosis of PMS but not PMDD, patients must have 3 to 4 symptoms, complain of functional impairment as a result of their symptoms, and identify symptoms as problematic enough to warrant treatment Symptoms of PMS/PMDD in at least 9 of 12 menstrual cycles during the year prior to screening Symptom-free during the follicular phase and impairment during the luteal phase Regular menstrual cycles Adequate methods of birth control Exclusion Criteria: Major depression, bipolar disorder, or psychotic disorders Hepatitis or hepatic failure Amenorrhea, oligomenorrhea, blood dyscrasias, or illnesses for which monoamine oxidase inhibitors must be prescribed Follicular phase symptoms consistent with a diagnosis of major depression, bipolar disorder, or psychotic disorders Co-existing condition that renders the patient unsuitable for the study Risk of suicide Antidepressants or other psychotropic medication Hypersensitivity or adverse reaction to sertraline Pregnancy, breast-feeding, or plans to become pregnant during the course of the study Depot hormonal preparation or any other medication that would lead to lack of menses or markedly irregular menses
Sites / Locations
- Yale School of Medicine
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
1
2
Participants will receive treatment as usual
Participants will take sertraline