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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: Recruiting Phase 4 study of Premenstrual Dysphoric Disorder (PMDD), sponsored by Johns Hopkins University.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (44% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome variable is levels of neuroactive steroids in blood; from the early luteal phase (2 days post ovulation) compared to the late luteal phase (days 5 to 1 prior to predicted menses onset)
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 |
What NCT06704594 shows while recruiting
NCT06704594 is an interventional study that assigns participants to a tested intervention. The registered 288 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (44% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06704594's enrollment target sits among peer trials
288 298th of 2000 higher than 1,701 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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