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Could a hyperactive immune system fuel PMDD? a new study investigates

NCT ID NCT07771426

What the study statuses mean

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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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 Results may not be published yet.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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This study explores whether inflammation in the body is linked to the mood and psychological symptoms of Premenstrual Dysphoric Disorder (PMDD). Researchers will compare women with PMDD to healthy controls, tracking daily emotions and behaviors over two menstrual cycles and taking blood samples to measure inflammatory markers. The goal is to better understand the biological and psychological factors behind PMDD, which could eventually lead to improved treatments.

What this could mean

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

What this could lead to
If inflammation is linked to PMDD symptoms, it could point toward new anti-inflammatory treatments for the condition.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The findings may not lead to new treatments, and the results may not apply to everyone with PMDD.

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.

Participants

About 120 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Oct 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.

Who is studied

Participants will be recruited from London and surrounding areas, United Kingdom.

Ages

18 to 42 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: Participants must: * Have been assigned female sex at birth (AFAB), with ovaries * Be aged between 18-42 years (inclusive) * Be able to provide written informed consent * Be premenopausal * Have regular menstrual cycles (24-35 days; 5-8 menstrual cycles within the previous 6 months) * Have a body mass index (BMI) between 18 and 30 kg/m². * Have access to a computer, tablet or smartphone with an internet connection. * Be registered with a UK General Practitioner (GP) and consent to the study team contacting their GP if clinically indicated. PMDD group only - Participants must additionally: • Meet DSM-5 diagnostic criteria for Premenstrual Dysphoric Disorder (PMDD), confirmed through prospective symptom ratings and the study diagnostic assessment. Healthy control group only - Participants must additionally: * Have no current or previous diagnosis of PMDD. * Report no clinically significant premenstrual symptoms on prospective symptom ratings. * Have no lifetime psychiatric illness * Meet all other study eligibility criteria. Exclusion Criteria: Participants will be excluded if they: * Have a lifetime history of a psychotic disorder (including schizophrenia, schizoaffective disorder or major depressive disorder with psychotic features) or bipolar disorder (past or present) * Meet criteria for any other current major psychiatric disorder that would interfere with study participation, as determined by the MINI International Neuropsychiatric Interview. * Have a history of drug or alcohol dependence within the previous 12 months. * Have a diagnosed intellectual disability, pervasive developmental disorder or significant neurological disorder (e.g. Alzheimer's disease, epilepsy or Parkinson's disease). * Are currently pregnant or breastfeeding, or are planning pregnancy during the study period. * Have an acute infection, autoimmune disorder, or regularly use anti-inflammatory or antibiotic medication that could influence immune biomarkers. * Have a current or previous gynaecological condition (e.g. endometriosis or polycystic ovary syndrome) or have undergone gynaecological surgery within the previous 12 months. * Have used hormonal contraception or other steroid hormone treatment within the previous 6 months (except emergency levonorgestrel contraception or temporary hormone treatment for oocyte cryopreservation that has not affected menstrual cycle regularity). * Have a significant medical condition that may affect study outcomes (e.g. cancer, inflammatory disease, liver disease, kidney disease or Crohn's disease). * Are currently participating in a Clinical Trial of an Investigational Medicinal Product (CTIMP). Eligibility following recent participation in a CTIMP will be considered on a case-by-case basis. * Are assessed as presenting an immediate or high risk of suicide requiring urgent clinical intervention. Suicidal ideation alone is not an exclusion criterion because it is recognised as a feature of PMDD; however, participants identified as being at significant risk will be excluded and referred to appropriate clinical services.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • Maurice Wohl Clinical Neuroscience Institute

    London, 'London, SE5 9RX, United Kingdom

More trials for these conditions

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