At a glance
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Psychophysiology, Neurosteroids, and Stress in Premenstrual Dysphoric Disorder
In Brief
A Phase 4 clinical trial evaluating Sertraline for PMDD and 2 related conditions. Completed, enrolled 84 participants across 1 site.
Detailed Summary
This study that aims to evaluate the psychophysiology of premenstrual mood disorders (PMDs) at baseline and after treatment with sertraline. Participants will include women with PMDs and healthy female controls. Participation involves a baseline visit to determine eligibility and three study visits that include questionnaires and stress reactivity assessment via an acoustic startle paradigm. Female participants with PMDs will receive sertraline during the premenstrual phase.
Study Details
Timeline
Interventions
Sertraline will be provided at a dose of 50 mg daily for up to 3 weeks, depending on the length of a woman's luteal phase. Medication will be taken only during the luteal phase. Women will initiate sertraline treatment upon determining that they have ovulated (using a urine luteinizing hormone (LH) Kit) and remain on sertraline until onset of their next menstrual period at which time they will stop taking the medication.