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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Premenstrual Dysphoric Disorder (PMDD)

In brief

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.

Key facts

Study ID

NCT06704594

Run by

Johns Hopkins University

People needed

288

Starts

2025-05-14

Expected to finish

2029-07-01

Last updated by the study team

2026-05-07

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• female sex,
• fluent in the English language
• regular menstrual cycles (24-35 days)
• age 18-50 years old
• ability to give written informed consent

You may not qualify if…

• 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 is running

• Reproductive Mental Health Center — Baltimore, Maryland, United States (enrolling)
• University of Virginia — Charlottesville, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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