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RecruitingAccepts healthy volunteersPhase 4

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

Johns Hopkins University · with National Institute of Mental Health (NIMH) · NCT06704594

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–50 · Women only
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
288
US sites recruiting
2
Study start
May 14, 2025
Record last updated
May 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: sertraline 50 mg daily; Placebo Oral Tablet

Conditions: Premenstrual Dysphoric Disorder (PMDD)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Reproductive Mental Health Center

    Baltimore, MD 21205

    Site contact: Victoria N Paone, B.S. · 443-685-4258 · vpaone1@jh.edu

  • University of Virginia

    Charlottesville, VA 22903

    Site contact: Lauren A Williamson, PhD · 434-297-4689 · LEA6D@uvahealth.org

Study contacts (from the official record)

  • Victoria Paone, B.S. · 4436854258 · vpaone1@jh.edu
  • Victoria Seo, B.S. · vseo1@jh.edu
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Allopregnanolone and Dynamic GABA-A Receptor Plasticity in… (NCT06704594) | Bored Studies