The SPARK-PMDD Study

NCT07771426 | Not Yet Recruiting

• 2 other identifiers: 360896223486/Z/21/Z
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premenstrual Dysphoric Disorder; Premenstrual Dysphoric Disorder (PMDD); PMDD

Keywords

menstrual cycle; pmdd; luteal phase; womens health; reproductive health; reproductive mental health; inflammation; stress; premenstrual; female

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment until study completion (approximately 3 months)

Secondary Outcomes (12)

• Sex Steroid Hormones (Comparing individuals with PMDD and controls)

  From enrollment until study completion (approximately 3 months)

• Stress Biomarkers (Comparing individuals with PMDD and controls)

  From enrollment until study completion (approximately 3 months)

• State Difficulties in Emotion Regulation Scale (Comparing individuals with PMDD and controls)

  From enrollment until study completion (approximately 3 months)

• Emotional Reactivity Scale (Comparing individuals with PMDD and controls)

  From enrollment until study completion (approximately 3 months)

• Positive and Negative Affect Schedule (Comparing individuals with PMDD and controls)

  From enrollment until study completion (approximately 3 months)

Study Arms (2)

Control

Eligible participants that pass inclusion and exclusion criteria who do not have premenstrual mood symptoms.

Premenstrual Dysphoric Disorder (PMDD)

Eligible participants that pass inclusion and exclusion criteria who do have premenstrual mood symptoms. Symptoms must be severe enough to meet PMDD criteria.

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (1)

Maurice Wohl Clinical Neuroscience Institute

London, 'London, SE5 9RX, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood (serum) and Saliva samples

MeSH Terms

Conditions

Premenstrual Dysphoric Disorder; Inflammation

Condition Hierarchy (Ancestors)

Premenstrual Syndrome; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Ellen R Lambert, DClinPsy

CONTACT

020 7848 0353; ellen.r.lambert@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 18, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)