An observational study in Premenstrual Dysphoric Disorder, PMDD and Premenstrual Dysphoric Disorder ( PMDD), sponsored by King's College London. Not yet recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by King's College London · Observational
Scientists have found that the immune system, the body's system dedicated to fighting infections, can be in a state of "hyperactivity" (i.e., more active than you would normally expect) in some people with depression and postnatal depression, despite the lack of any actual ongoing infection. This response is referred to as inflammation. This discovery has unveiled unique opportunities to identify new medications to help patients with this heightened inflammation who have also not been responding to their antidepressant medications.
This study aims to explore how inflammation in the body may be linked to symptoms of Premenstrual Dysphoric Disorder (PMDD) across the menstrual cycle, and how thoughts, emotions, and behaviours also may change throughout the cycle. We are recruiting two groups of people: People with a clinical or provisional (suspected) diagnosis of PMDD, and healthy controls who experience mild/no premenstrual changes.
Over a two-month period, participants will complete daily psychological assessments across two menstrual cycles and will come into King's College Hospital (KCH) twice during one menstrual cycle to provide blood samples to measure their inflammation. By comparing these groups, we hope to gain a better understanding of the biological and psychological factors involved in PMDD, with the long-term goal of improving treatment options.
Premenstrual dysphoric disorder (PMDD) is a reproductive mood disorder characterised by impairing emotional, cognitive, and physical symptoms that emerge during the premenstrual (luteal) phase of the menstrual cycle and remit shortly after menstruation begins. PMDD may reflect heightened sensitivity to normal fluctuations in ovarian hormones, with emerging evidence suggesting that interactions between sex hormones, inflammation, and psychological processes may contribute to symptom emergence.
Recent prospective research has found that inflammatory markers, including CXCL8 and TNFα, are elevated during the luteal phase and that CXCL8 is associated with PMDD symptom severity. Psychological research has also identified cyclical changes in emotional reactivity, distress tolerance, rumination, and related processes among individuals with PMDD, suggesting that these may represent important and potentially modifiable treatment targets.
The primary aims of this study are to investigate whether inflammatory markers differ between individuals with PMDD and healthy controls across the follicular and luteal phases of the menstrual cycle, and to determine whether inflammatory markers are associated with PMDD symptom severity.
The secondary aims are to examine whether key emotional and cognitive variables differ across menstrual cycle phases between individuals with PMDD and healthy controls, and to determine whether the magnitude of these psychological changes is associated with PMDD symptom severity. The study will use a repeated-measures design, with participants assessed during both the follicular and luteal phases of the menstrual cycle.
Exploratory aims are to examine daily fluctuations in psychological outcomes across two consecutive menstrual cycles and, in a subgroup of 20 participants, to explore the lived experience of PMDD, attitudes towards current biological and psychological treatments, and perspectives on potential novel treatment targets.
42 studies on the registry are indexed under Premenstrual Dysphoric Disorder; 10 are open to participants now.
Browse Premenstrual Dysphoric Disorder studies →King's College London is the lead sponsor of 520 studies on the registry; 126 are open to participants now.
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Participants will be recruited from London and surrounding areas, United Kingdom.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must:
PMDD group only - Participants must additionally:
Healthy control group only - Participants must additionally:
Exclusion Criteria:
Participants will be excluded if they:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible participants that pass inclusion and exclusion criteria who do not have premenstrual mood symptoms.
Eligible participants that pass inclusion and exclusion criteria who do have premenstrual mood symptoms. Symptoms must be severe enough to meet PMDD criteria.
Inflammatory Biomarkers (Comparing individuals with PMDD and controls)
The investigators will be collecting peripheral blood samples and assaying inflammatory markers, including high-sensitivity C-reactive protein (hs-CRP) and pro-inflammatory and anti-inflammatory cytokines, including interferon (IFN)-γ, interleukin (IL)-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, and TNF-α.
Time frame: From enrollment until study completion (approximately 3 months)
Sex Steroid Hormones (Comparing individuals with PMDD and controls)
The investigators will be collecting peripheral blood samples and assaying sex steroid hormones including estradiol, progesterone, testosterone, follicle-stimulating hormone, and luteinising hormone.
Time frame: From enrollment until study completion (approximately 3 months)
Stress Biomarkers (Comparing individuals with PMDD and controls)
The investigators will collect saliva samples to assess cortisol awakening response.
Time frame: From enrollment until study completion (approximately 3 months)
State Difficulties in Emotion Regulation Scale (Comparing individuals with PMDD and controls)
The investigators will collect self-reported emotion dysregulation, including nonacceptance of current emotions, difficulties modulating emotional and behavioural responses in the moment, limited awareness and clarity of current emotions).
Time frame: From enrollment until study completion (approximately 3 months)
Emotional Reactivity Scale (Comparing individuals with PMDD and controls)
The investigators will collect self-reported Emotional Sensitivity, Arousal/Intensity, and Persistence
Time frame: From enrollment until study completion (approximately 3 months)
Positive and Negative Affect Schedule (Comparing individuals with PMDD and controls)
The investigators will collect self-reported positive and negative affect.
Time frame: From enrollment until study completion (approximately 3 months)
Perceived Stress Scale (Comparing individuals with PMDD and controls)
The investigators will collect self-reported subjective stress in the course of daily life.
Time frame: From enrollment until study completion (approximately 3 months)
Forms of Self-Criticising/Attacking and Self-Reassuring Scale (Comparing individuals with PMDD and controls)
The investigators will collect self-reported information regarding how self-critical/attacking or how supportive/reassuring people are when things go wrong for them.
Time frame: From enrollment until study completion (approximately 3 months)
The State Self-Compassion Scale (Comparing individuals with PMDD and controls)
The investigators will collect self-reported information regarding how people typically act towards themselves in difficult times.
Time frame: From enrollment until study completion (approximately 3 months)
Perseverative Thinking Questionnaire (Comparing individuals with PMDD and controls)
The investigators will collect self-reported repetitive negative thinking in daily life.
Time frame: From enrollment until study completion (approximately 3 months)
Anger Rumination Scale (Comparing individuals with PMDD and controls)
The investigators will collect self-reported anger rumination or "the tendency to focus on angry moods, recall past anger episodes, and think over the causes and consequences of anger episodes"
Time frame: From enrollment until study completion (approximately 3 months)
Cognitive Behavioural Avoidance Scale (Comparing individuals with PMDD and controls)
The investigators will collect self-reported cognitive/behavioural and social/non-social dimensions of avoidance.
Time frame: From enrollment until study completion (approximately 3 months)
Entrapment Scale (Comparing individuals with PMDD and controls)
The investigators will collect self-reported feelings of internal and external entrapment, which are experiences of being unable to escape unbearable thoughts, feelings and situations.
Time frame: From enrollment until study completion (approximately 3 months)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Sep 2028, 20 months later.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Premenstrual Dysphoric Disorder →