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PMS/PMDD Treatment Trial

We take PMS seriously!

The primary aims of this clinical trial were to assess whether the serotonin reuptake inhibitor (SRI) sertraline (Zoloft™) is more effective than placebo at ameliorating symptoms of PMDD when capsules are taken from the onset of premenstrual symptoms through first few days of menses (i.e., "symptom-onset dosing"). In addition, this study evaluated whether stopping capsules at the onset of menses, or shortly thereafter, is associated with SRI discontinuation symptoms.

The secondary objectives of this study were to: (1) estimate whether improvement in functional impairment and quality of life was greater with symptom-onset dosing using sertraline than with similarly administered placebo; (2) explored whether greater overall symptom severity, suicidal symptoms and severe physical symptoms are moderators of response for symptom onset treatment; and (3) examined whether symptom onset treatment is effective in treating physical symptoms in addition to mood symptoms.

Women were eligible to participate if they were between the ages of 18 and 48, had regular menstrual cycles, experienced severe PMS / PMDD symptoms every month and used a reliable form of birth control. Women were not eligible to participate if they were currently depressed or taking anti-depressant or anti-anxiety medication.

Recruitment for this study has ended, and data is currently being analyzed. Study updates will be posted as they become available.

Yale HIC#060900183