RecruitingPhase 4NCT06704594

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


Sponsor

Johns Hopkins University

Enrollment

288 participants

Start Date

May 14, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how a naturally occurring hormone called allopregnanolone (which fluctuates with the menstrual cycle) affects GABA receptors in the brain — and how this relates to premenstrual dysphoric disorder (PMDD), a severe form of PMS that causes significant mood and emotional symptoms before each period. **You may be eligible if...** - You are a woman between 18 and 50 years old - You have regular menstrual cycles (24–35 days) - You are fluent in English - You are able to give written consent **You may NOT be eligible if...** - You have taken any psychiatric medications in the past 2 months - You have a substance use disorder in the past 6 months - You have a history of a psychotic disorder, bipolar disorder, or major depression with psychosis - You use hormonal contraceptives or other steroid hormones - You have been pregnant in the past 6 months - You have a history of seizures, severe liver problems, or a heart rhythm condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGsertraline 50 mg daily

The intervention will be in the form of an oral pill, taken daily, from the day of positive urine ovulation test result until the day of menses onset.

DRUGPlacebo Oral Tablet

The placebo oral tablet will be of the same shape, color, and manufacturer as the sertraline 50 mg oral tablets. Tablet will be taken daily, from the day of positive urine ovulation test result until the day of menses onset.


Locations(2)

Reproductive Mental Health Center

Baltimore, Maryland, United States

University of Virginia

Charlottesville, Virginia, United States

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NCT06704594


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