Actively Recruiting
Allopregnanolone and Dynamic GABA-A Receptor Plasticity in Selective Serotonin Reuptake Inhibitor Responsive Premenstrual Dysphoric Disorder
Led by Johns Hopkins University · Updated on 2026-05-07
288
Participants Needed
2
Research Sites
215 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Allopregnanolone and Dynamic GABA-A Receptor Plasticity in Selective Serotonin Reuptake Inhibitor Responsive Premenstrual Dysphoric Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female sex
- Fluent in English
- Regular menstrual cycles of 24-35 days
- Age between 18 and 50 years old
- Ability to provide written informed consent
You will not qualify if you...
- Use of psychiatric medications within the past 2 months
- Substance use disorder within the past 6 months
- History of psychotic disorders including schizophrenia
- Schizoaffective disorder or major depression with psychotic features
- Any psychiatric disorder other than PMDD in the past year
- Active suicidal thoughts with plan or attempt in past 6 months
- Use of steroid hormones or hormonal contraceptives (except levonorgestrel emergency contraceptive) in past 2 months
- Pregnancy within the past 6 months
- History of brain injury
- Current or past endocrine disorders including uncontrolled diabetes or thyroid disease
- Body mass index over 40
- History of arrhythmias, severe liver impairment, or seizure disorder
- Current use of methylene blue or linezolid
- Use of prohibited medications including MAOIs, pimozide, and disulfiram
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Reproductive Mental Health Center
Baltimore, Maryland, United States, 21205
Actively Recruiting
2
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
V
Victoria Paone, B.S.
CONTACT
V
Victoria Seo, B.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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