Home › Premenstrual Syndrome › NCT06704594
Allopregnanolone and Dynamic GABA-A Receptor Plasticity in Selective Serotonin Reuptake Inhibitor Responsive Premenstrual Dysphoric Disorder
Who can join
Ages 18 to 50 · Women · Healthy volunteers welcome
Full eligibility 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
About the study
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.
What is being tested
- sertraline 50 mg daily (drug)
- Placebo Oral Tablet (drug)
Sponsor: Johns Hopkins University · Participants: 288 · Started: May 14, 2025
Contact the study team
- Victoria Paone, B.S. · Phone: 4436854258
Official record on ClinicalTrials.gov — NCT06704594
Locations in the U.S.
| Maryland | Reproductive Mental Health Center, Baltimore |
| Virginia | University of Virginia, Charlottesville |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.