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Scientists probe brain chemistry behind severe PMS to unlock better treatments

NCT ID NCT06704594

Knowledge-focused Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how brain chemicals called neuroactive steroids change across the menstrual cycle in women with Premenstrual Dysphoric Disorder (PMDD) compared to healthy women. It also tests whether a low-dose antidepressant (sertraline) affects these chemical levels. The goal is to better understand what causes PMDD and how current treatments work, involving 288 women aged 18-50.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sertraline (an antidepressant)
What this could lead to
If successful, this could reveal why some women develop PMDD and how antidepressants help, pointing toward more targeted treatments.
What could go wrong
This is an early-stage, observational study focused on understanding mechanisms, not testing a new treatment. Results may not lead directly to new therapies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 288 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

premenstrual dysphoric disorder premenstrual tension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Premenstrual dysphoric disorder ( PMDD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Reproductive Mental Health Center

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.