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

Last updated: May 13, 2025
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

4

Condition

Premenstrual Syndrome

Severe Premenstrual Symptom

Premenstrual Dysphoric Disorder (Pmdd)

Treatment

sertraline 50 mg daily

Placebo Oral Tablet

Clinical Study ID

NCT06704594
IRB00445770
R01MH134904
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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

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 emergencycontraceptive) in past 2 months

  • pregnancy in past 6 months

  • history of brain injury

  • current or history of endocrine disorder including uncontrolled diabetes or thyroiddisease

  • 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

Study Design

Total Participants: 288
Treatment Group(s): 2
Primary Treatment: sertraline 50 mg daily
Phase: 4
Study Start date:
April 25, 2025
Estimated Completion Date:
July 01, 2029

Connect with a study center

  • Reproductive Mental Health Center

    Baltimore, Maryland 21205
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

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