Could a hyperactive immune system fuel PMDD? a new study investigates
NCT ID NCT07771426
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for PMDD are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
- Psilocybin microdoses put to the test for severe PMS mood symptoms
- Hormone clues behind severe PMS symptoms under investigation
- Could a tiny ear device ease severe PMS and menopause symptoms?
- Wearable Brain-Zapping device aims to ease Period-Related mood and brain fog
- New study tests sleep workshop as Drug-Free aid for PMDD
- Scientists probe brain chemistry behind severe PMS to unlock better treatments