Investigating hormone effects on premenstrual dysphoric disorder
Official title: Allopregnanolone and Dynamic GABA-A Receptor Plasticity in Selective Serotonin Reuptake Inhibitor Responsive Premenstrual Dysphoric Disorder
Run by Johns Hopkins University · NCT06704594 · Data updated 2026-11-12
This study is trying to see how certain hormones and a low-dose antidepressant can affect women with premenstrual dysphoric disorder compared to those without it.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 288 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Status | Recruiting |
| Started | May 14, 2025 |
| Main results expected | July 1, 2029 |
| Study ends | July 1, 2029 |
| Registry record updated | May 7, 2026 |
| Trial ID | NCT06704594 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18-50 with regular menstrual cycles who experience PMDD symptoms.
✕Probably not a fit
Patients with a history of severe psychiatric disorders or those currently on psychiatric medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study examines the role of neuroactive steroid hormones and GABA-A receptors in premenstrual dysphoric disorder (PMDD) by comparing blood levels and receptor expression in women with PMDD and healthy controls. Participants will receive either a low-dose antidepressant (sertraline) or a placebo during the luteal phase of their menstrual cycle. The goal is to understand how these factors change across the menstrual cycle and how they relate to PMDD symptoms. This research aims to enhance the understanding of PMDD mechanisms and treatment responses.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for women suffering from PMDD.
How similar studies have gone: Other studies have explored hormonal influences on PMDD, but this specific approach is novel in its focus on GABA-A receptor plasticity.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * female sex, * fluent in the English language * regular menstrual cycles (24-35 days) * age 18-50 years old * ability to give written informed consent Exclusion Criteria: * psychiatric medication use in the past 2 months * substance use disorder in the past 6 months * lifetime history of psychotic disorder including schizophrenia * schizoaffective disorder, major depression with psychotic features * history of psychiatric disorder other than PMDD in past year * active suicidal ideation with plan or attempt in past 6 months * steroid hormone or hormonal contraceptive use (except levonorgestrel as emergency contraceptive) in past 2 months * pregnancy in past 6 months * history of brain injury * current or history of endocrine disorder including uncontrolled diabetes or thyroid disease * BMI\>40 * History of arrythmias, severe liver impairment, history of seizure disorder * If currently taking the following meds: methylene blue, linezolid * Other prohibited concomitant meds are Monoamine oxidase inhibitors (MAOIs), pimozide, and disulfiram
Where it's running
-
Reproductive Mental Health Center
Baltimore, Maryland, United States Recruiting -
University of Virginia
Charlottesville, Virginia, United States Recruiting
Study contacts
- Principal investigator: Liisa Hantsoo, PhD — Johns Hopkins University
- Study coordinator: Victoria Paone, B.S.
- Email: vpaone1@jh.edu
- Phone: 4436854258
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Do PMDD patients have a different mid-luteal hormone balance than people without PMDD?
This study tests whether people with PMDD have different mid-luteal levels of progesterone and estradiol, and their ratio, compared with healthy controls.
-
Epigenetic markers linked to PMDD across the menstrual cycle
This study tests whether blood epigenetic markers can tell apart women with PMDD from women without PMDD at different points in the menstrual cycle.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.