RECRUITING

Allopregnanolone and Dynamic GABA-A Receptor Plasticity in Selective Serotonin Reuptake Inhibitor Responsive Premenstrual Dysphoric Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Premenstrual dysphoric disorder (PMDD) is a severe affective disorder impacting millions of women worldwide, thought to be due to altered sensitivity to hormone fluctuations across the menstrual cycle. Neuroactive steroid hormones (NAS) and the gamma-aminobutyric acid (GABA)-A receptor (GABAAR) are thought to play a role in PMDD. This research will assess the blood levels of GABAergic NAS, expression of associated enzymes, and expression of GABAAR subunits across the premenstrual (luteal) phase of the menstrual cycle in healthy controls and individuals with PMDD. Within the PMDD group, the investigators will assess how these measures are affected by a low-dose antidepressant medication versus placebo. The results will provide a comprehensive view of the changes in these systems across the menstrual cycle and will add to the investigator's understanding of the mechanisms that underlie PMDD, as well as therapeutic mechanisms of PMDD treatment.

Official Title

Allopregnanolone and Dynamic GABA-A Receptor Plasticity in Selective Serotonin Reuptake Inhibitor Responsive Premenstrual Dysphoric Disorder

Quick Facts

Study Start:2025-04-01
Study Completion:2029-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06704594

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * female sex,
  2. * fluent in the English language
  3. * regular menstrual cycles (24-35 days)
  4. * age 18-50 years old
  5. * ability to give written informed consent
  1. * psychiatric medication use in the past 2 months
  2. * substance use disorder in the past 6 months
  3. * lifetime history of psychotic disorder including schizophrenia
  4. * schizoaffective disorder, major depression with psychotic features
  5. * history of psychiatric disorder other than PMDD in past year
  6. * active suicidal ideation with plan or attempt in past 6 months
  7. * steroid hormone or hormonal contraceptive use (except levonorgestrel as emergency contraceptive) in past 2 months
  8. * pregnancy in past 6 months
  9. * history of brain injury
  10. * current or history of endocrine disorder including uncontrolled diabetes or thyroid disease
  11. * BMI\>40
  12. * History of arrythmias, severe liver impairment, history of seizure disorder
  13. * If currently taking the following meds: methylene blue, linezolid
  14. * Other prohibited concomitant meds are Monoamine oxidase inhibitors (MAOIs), pimozide, and disulfiram

Contacts and Locations

Study Contact

Liisa Hantsoo, Doctor of Philosophy, PhD
CONTACT
215-645-7035
lhantso1@jhmi.edu
Victoria Paone, B.S.
CONTACT
4436854258
vpaone1@jh.edu

Principal Investigator

Liisa Hantsoo, PhD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Reproductive Mental Health Center
Baltimore, Maryland, 21205
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Liisa Hantsoo, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01
Study Completion Date2029-07-01

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2029-07-01

Terms related to this study

Keywords Provided by Researchers

  • pmdd
  • premenstrual dysphoric disorder
  • pms
  • premenstrual symptoms
  • premenstrual syndrome
  • blood draw
  • sertraline
  • ssri
  • mood symptoms
  • women
  • women with pms
  • women with pmdd
  • luteal phase
  • follicular phase
  • womens reproductive mental health
  • womens health
  • womens reproductive health
  • menstrual cycle
  • menses
  • periods
  • allopregnanolone
  • neuroactive steroids
  • inflammatory markers
  • epigenetics

Additional Relevant MeSH Terms

  • Premenstrual Dysphoric Disorder (PMDD)