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Identification and Validation of Epigenetic Biomarkers of PMDD

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at mood changes and epigenetic markers—signs of how genes are turned on or off—during the menstrual cycle. It is for females ages 18–50 with regular periods, either with PMS/PMDD (mood symptoms before periods) or without mood symptoms before periods. Researchers will collect samples, such as blood, to see whether these markers are linked to PMDD.

This research is being done to examine epigenetic markers and mood changes across the menstrual cycle, particularly in premenstrual dysphoric disorder (PMDD). The investigators previously identified epigenetic biomarkers of postpartum depression, another reproductive affective disorder, and in this study aim to determine if these biomarkers also distinguish PMDD cases from healthy controls at different points in the menstrual cycle. By collecting biological samples (such as blood) and monitoring mood changes across the menstrual cycle, the investigators will be able to determine whether these epigenetic markers are associated with PMDD. The investigators plan to study these epigenetic markers during the follicular phase (roughly the first half of the menstrual cycle, from menses until ovulation) and the luteal phase (roughly the second half of the menstrual cycle, from ovulation to menses). The investigators will study this in two groups: 1) individuals who do NOT have premenstrual mood symptoms, and 2) individuals with premenstrual syndrome/premenstrual dysphoric disorder (PMS/PMDD). The results will provide a comprehensive view of the changes in these systems across the menstrual cycle. This will add to the investigators understanding of the mechanisms that may cause PMS/PMDD.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Female sex.
  • Age 18–50.
  • Regular menstrual cycles lasting 24–35 days.
  • Able to give written consent to join the study.

Who can't join

  • Used mental health medicines or had a substance use disorder in the past 2 months.
  • Ever had a psychotic disorder, which can affect what you believe or sense is real.
  • Had a mental health disorder other than PMDD in the past year.
  • Had suicidal thoughts with a plan or made a suicide attempt in the past 6 months.
  • Used steroid hormones or hormonal birth control in the past 2 months, except levonorgestrel emergency birth control.
  • Were pregnant in the past 6 months, or have ever had a brain injury.
  • Have or have had a hormone-related disorder, including uncontrolled diabetes or thyroid disease.
  • Have a body mass index (BMI), a measure based on height and weight, over 40.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

MD