Clinical Trial

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

Study acronym: BLOOM
Recruiting Phase 4
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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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2024-11-21; most recent amendment 2026-05-06.
Status change: Not Yet Recruiting → Recruiting 2025-03-20
Trial Details
NCT Number NCT06704594
Lead Sponsor Johns Hopkins University
Collaborators: National Institute of Mental Health (NIMH)
Conditions Premenstrual Dysphoric Disorder (PMDD)
Enrollment 288 participants
Start Date 2025-05-14
Primary Completion 2029-07-01 (estimated)
Study Completion 2029-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-07