Identification and Validation of Epigenetic Biomarkers of PMDD

Launched by JOHNS HOPKINS UNIVERSITY · Jan 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a condition called Premenstrual Dysphoric Disorder (PMDD), which is a severe form of premenstrual syndrome that affects mood and emotions. The researchers want to find out if certain biological markers, known as epigenetic markers, can help identify women who have PMDD compared to those who do not. They will collect blood samples and track mood changes throughout the menstrual cycle, focusing on two phases: the first half (when the body prepares for ovulation) and the second half (after ovulation). By comparing these two groups—women with PMDD and those without—scientists hope to learn more about what causes these mood changes.

To be eligible for this study, participants must be females aged 18 to 50 with regular menstrual cycles and must be able to provide informed consent. However, women who have taken psychiatric medications recently, have certain mental health conditions, or have specific health issues such as hormonal changes or a high body mass index (BMI) won't be able to join. Those who participate can expect to provide blood samples and share their mood experiences during their menstrual cycle, contributing to important research that could lead to better understanding and treatment options for PMDD.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • female sex
• • regular menstrual cycles (24-35 days)
• • age 18-50 years
• • ability to give written informed consent
• Exclusion Criteria:
• • psychiatric medication use in the past 2 months;
• • substance use disorder in the past 2 months (per MINI);
• • lifetime history of psychotic disorder including schizophrenia, schizoaffective disorder, major depression with psychotic features (per MINI);
• • history of psychiatric disorder other than PMDD in past year (per MINI);
• • active suicidal ideation with plan or attempt in past 6 months (per MINI);
• • steroid hormone or hormonal contraceptive use (except levonorgestrel as emergency contraceptive) in past 2 months;
• • pregnancy in past 6 months;
• • history of brain injury;
• • current or history of endocrine disorder including uncontrolled diabetes or thyroid disease;
• • BMI\>40.