Premenstrual Syndrome Clinical Trial
Official title:
Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder
This study will determine whether characteristics of women with Premenstrual Syndrome influence response to treatment with serotonin reuptake inhibitors and whether SRIs can alleviate premenstrual symptoms.
Moderate to severe premenstrual disturbances afflict up to 20 percent of women. Studies have
shown the use of serotonin reuptake inhibitors (SRIs) during the luteal phase of the
menstrual cycle to be effective in improving symptoms in women with premenstrual dysphoric
disorder (PMDD). Unfortunately, SRI treatment has only been evaluated in controlled clinical
trials, and evidence suggests that patients in these clinical trials are not representative
of women commonly seen in clinical practice. Thus, the real-world feasibility of
intermittent dosing is questionable.
Patients in this study receive sertraline (Zoloft) during the luteal phase of their
menstrual cycle every month for 6 months. The dose may be modified based on structured
interviews with the patients. Assessments include questionnaires and interviews which take
place at study start, at midpoint, and at the end of the study.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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