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NCT06704594 · ClinicalTrials.gov registry record · Phase 4
Allopregnanolone and Dynamic GABA-A Receptor Plasticity in Selective Serotonin Reuptake Inhibitor Responsive Premenstrual Dysphoric Disorder
A Phase 4 study of Premenstrual Dysphoric Disorder (PMDD), sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 288
- Enrollment target
- 2
- Study locations
NCT06704594 is a Phase 4 study of Premenstrual Dysphoric Disorder (PMDD) that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 288 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT06704594, a Phase 4 study of Premenstrual Dysphoric Disorder (PMDD), is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 288 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo Oral Tablet
- DRUG sertraline 50 mg daily
Study Locations (2)
Maryland
- Reproductive Mental Health Center - Baltimore
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2025-05-14 |
| Est. Completion | 2029-07-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06704594
The ClinicalTrials.gov registry entry for NCT06704594 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Premenstrual Dysphoric Disorder (PMDD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT06704594 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Maryland, Virginia.
Frequently Asked Questions
What is clinical trial NCT06704594 about?
NCT06704594 is a clinical study titled "Allopregnanolone and Dynamic GABA-A Receptor Plasticity in Selective Serotonin Reuptake Inhibitor Responsive Premenstrual Dysphoric Disorder". 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 ...
What is the current status of trial NCT06704594?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 288 participants. The study started on 2025-05-14. Estimated completion is 2029-07-01.
What conditions does trial NCT06704594 study?
This clinical trial studies the following conditions: Premenstrual Dysphoric Disorder (PMDD).
What interventions are being tested in trial NCT06704594?
The interventions under investigation include: Placebo Oral Tablet (DRUG), sertraline 50 mg daily (DRUG).
Who is sponsoring clinical trial NCT06704594?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06704594 being conducted?
This trial has 2 study locations across Maryland, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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