Actively Recruiting
Allopregnanolone and Dynamic GABA-A Receptor Plasticity in Selective Serotonin Reuptake Inhibitor Responsive Premenstrual Dysphoric Disorder
Led by Johns Hopkins University ยท Updated on 2026-05-07
288
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Premenstrual dysphoric disorder (PMDD) is a serious mood disorder affecting many women, believed to be caused by changes in sensitivity to hormone fluctuations during the menstrual cycle. This research will study the levels of certain brain-related hormones and receptor proteins in women with and without PMDD during the premenstrual phase. It will also explore how a low-dose antidepressant medication affects these measures in women with PMDD to better understand the disorder and its treatment mechanisms. The study includes three groups: women without premenstrual symptoms, women with PMDD taking sertraline 50 mg daily during the second menstrual cycle, and women with PMDD taking a placebo pill in the second cycle. Participants will track their mood, complete surveys, and have blood samples taken multiple times across one or two menstrual cycles. The sertraline or placebo is taken from ovulation until the start of menstruation in the second cycle. Participants will be involved in mood tracking, self-report questionnaires, and blood draws throughout the study. Researchers will measure neuroactive steroid levels, enzyme expression related to these steroids, and receptor subunit levels during and after the menstrual phases. The study will monitor these changes over cycles lasting up to three months, with careful safety and symptom monitoring. Participation lasts across one or two menstrual cycles depending on the group.
CONDITIONS
Brief Title
Allopregnanolone and Dynamic GABA-A Receptor Plasticity in Selective Serotonin Reuptake Inhibitor Responsive Premenstrual Dysphoric Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female sex
- Fluent in the English language
- Regular menstrual cycles lasting 24 to 35 days
- Age between 18 and 50 years old
- Ability to give written informed consent
You will not qualify if you...
- Use of psychiatric medication in the past 2 months
- Substance use disorder in the past 6 months
- Lifetime history of psychotic disorders including schizophrenia
- History of schizoaffective disorder or major depression with psychotic features
- Psychiatric disorder other than PMDD in the past year
- Active suicidal thoughts with plan or attempt in past 6 months
- Use of steroid hormones or hormonal contraceptives (except levonorgestrel emergency contraceptive) in past 2 months
- Pregnancy in past 6 months
- History of brain injury
- Current or past endocrine disorders including uncontrolled diabetes or thyroid disease
- Body mass index over 40
- History of arrhythmias, severe liver impairment, or seizure disorder
- Current use of medications such as methylene blue, linezolid, MAO inhibitors, pimozide, or disulfiram
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Across two menstrual cycles
Participants with premenstrual dysphoric disorder take a daily oral pill of sertraline 50 mg or placebo from the day of positive urine ovulation test until the day of menses onset in the second menstrual cycle. Participants without premenstrual symptoms track mood and complete blood draws without taking medication.
Mood tracking and self-report surveys throughout; up to 8 blood draws over two cycles
Trial Site Locations
Total: 2 locations
1
Reproductive Mental Health Center
Baltimore, Maryland, United States, 21205
Actively Recruiting
2
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
V
Victoria Paone, B.S.
V
Victoria Seo, B.S.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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