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.
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 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).
Participants will be recruited from London and surrounding areas, United Kingdom.
Case-control
Prospective
Not listed
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.
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.
Stress Biomarkers (Comparing individuals with PMDD and controls)
The investigators will collect saliva samples to assess cortisol awakening response.
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).
Emotional Reactivity Scale (Comparing individuals with PMDD and controls)
The investigators will collect self-reported Emotional Sensitivity, Arousal/Intensity, and Persistence
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King's College London
Lead sponsor
South London and Maudsley NHS Foundation Trust
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
