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

Study acronym: BLOOM
StatusRecruiting
PhasePhase 4
Started2025-05-14
View on ClinicalTrials.gov ↗

Amendment history

2026-05-06
minor
Study Status, Contacts/Locations v11
Re-verified, no change to tracked fields
2025-06-02
minor
Study Status v10
Start date2025-04-25→2025-05-14
2025-05-13
minor
Study Status, Contacts/Locations v9
Study sites1→2
2025-04-08
minor
Study Status v8
Start date2025-04-01→2025-04-25
2025-03-25
minor
Study Status, Study Description, Arms and Interventions, Outcome Measures, IPDSharing v7
Secondary endpointsdetails revised at 2 of 2 entries
Show 6 earlier versions
2025-03-20
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v6
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2025-03-04
minor
Study Status v5
Start date2025-03-15→2025-04-01
2025-02-07
minor
Study Status, Eligibility v4
Eligibility criteria+1 characters
[...] use in the past 2 months substance use disorder in the past 26 yearsmonths lifetime history of psychotic disorder including schizophre [...]
2025-02-05
minor
Study Status v3
Start date2025-02-01→2025-03-15
2025-01-08
minor
Study Status v2
Start date2025-01-15→2025-02-01
2024-12-12
minor
Study Status v1
Start date2024-12-01→2025-01-15
2024-11-21
minor
Original filing
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.
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