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๐Ÿ›๏ธ Verified NIH Protocol โ€ข Sourced via U.S. National Library of Medicine (Last Synced: 2026-05-07)

Allopregnanolone and Dynamic GABA-A Receptor Plasticity in Selective Serotonin Reuptake Inhibitor Responsive Premenstrual Dysphoric Disorder

๐ŸŸข Recruiting Phase 4 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Johns Hopkins University

๐Ÿฉบ Protocol Summary

Premenstrual dysphoric disorder (PMDD) is a severe affective disorder impacting millions of women worldwide, thought to be due to altered sensitivity to hormone fluctuations across the menstrual cycle. Neuroactive steroid hormones (NAS) and the gamma-aminobutyric acid (GABA)-A receptor (GABAAR) are thought to play a role in PMDD. This research will assess the blood levels of GABAergic NAS, expression of associated enzymes, and expression of GABAAR subunits across the premenstrual (luteal) phase of the menstrual cycle in healthy controls and individuals with PMDD. Within the PMDD group, the investigators will assess how these measures are affected by a low-dose antidepressant medication versus placebo. The results will provide a comprehensive view of the changes in these systems across the menstrual cycle and will add to the investigator's understanding of the mechanisms that underlie PMDD, as well as therapeutic mechanisms of PMDD treatment.

Primary Research Facility: Reproductive Mental Health Center (Baltimore, Maryland)

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๐Ÿ“ Primary Site Map

Site: Reproductive Mental Health Center โ€” Baltimore, Maryland

๐Ÿ“ All Participating Trial Locations (2 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. Reproductive Mental Health Center โ€” Baltimore, Maryland โ€ข Contact: (443) 685-4258
2. University of Virginia โ€” Charlottesville, Virginia โ€ข Contact: (434) 297-4689

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๐Ÿ’ฐ Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act ยง 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

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๐Ÿ›๏ธ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT06704594 โ€ข Last Synced: 2026-05-07
View on ClinicalTrials.gov โ†—
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