Identification and Validation of Epigenetic Biomarkers of PMDD
Launched by JOHNS HOPKINS UNIVERSITY · Jan 8, 2025
Trial Information
Current as of July 25, 2025
Not yet recruiting
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.
About Johns Hopkins University
Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Baltimore, Maryland, United States
Patients applied
Trial Officials
Liisa Hantsoo, Ph.D.
Principal Investigator
Johns Hopkins University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported