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Sertraline and PMDD Study

This study is looking into Premenstrual Dysphoric Disorder (PMDD), a severe mood disorder affecting many women. Researchers believe PMDD might be linked to how your body reacts to hormone changes during your menstrual cycle, specifically involving certain brain chemicals (neuroactive steroid hormones and GABA-A receptors). This study will compare blood levels of these chemicals in women with PMDD and healthy women. For women with PMDD, the study will also look at how a low dose of sertraline (an antidepressant) or a placebo (an inactive pill) affects these levels. The main goal is to measure these neuroactive steroid levels before your period starts. You may be able to join if you are a woman between 18 and 50 years old with regular periods and can speak English.

Study design
This is an interventional study planning to enroll 288 participants. It will compare sertraline 50 mg daily to a placebo oral tablet.
What's involved
You would take an oral pill daily from the day of a positive ovulation test until your period starts.
Compensation
Not stated in the trial record.
Follow-up
Neuroactive steroid levels will be measured after ovulation up to 2 days, and up to 5 days before your predicted period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06704594

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

Recruiting
PHASE4Ages 18–50InterventionalTreatment
Johns Hopkins University
~288 participants
Updated 2026-05-07 on ClinicalTrials.gov
What's tested:sertraline 50 mg dailyPlacebo Oral Tablet

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neuroactive Steroid Levels
Measured over Post ovulation up to 2 days, up to 5 days pre-menses prediction

Conditions

Premenstrual Dysphoric Disorder (PMDD)

Explore related trials

Premenstrual Dysphoric Disorder

NCT06704594

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Reproductive Mental Health Center

    Baltimore, Marylandstudy coordinator listed

    Recruiting

  • University of Virginia

    Charlottesville, Virginiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Liisa Hantsoo, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Victoria Paone, B.S.
[email protected]
4436854258
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Neuroactive Steroid LevelsPost ovulation up to 2 days, up to 5 days pre-menses prediction

    The primary outcome variable is levels of neuroactive steroids in blood; from the early luteal phase (2 days post ovulation) compared to the late luteal phase (days 5 to 1 prior to predicted menses onset)