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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • female sex, - fluent in the English language - regular menstrual cycles (24-35 days) - age 18-50 years old - ability to give written informed consent

Exclusion Criteria

  • psychiatric medication use in the past 2 months - substance use disorder in the past 6 months - lifetime history of psychotic disorder including schizophrenia - schizoaffective disorder, major depression with psychotic features - history of psychiatric disorder other than PMDD in past year - active suicidal ideation with plan or attempt in past 6 months - 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 - History of arrythmias, severe liver impairment, history of seizure disorder - If currently taking the following meds: methylene blue, linezolid - Other prohibited concomitant meds are Monoamine oxidase inhibitors (MAOIs), pimozide, and disulfiram

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Control 		Participants delegated to the "control" arm will be individuals without premenstrual symptoms in the luteal phase of the menstrual cycle. Participants will be asked to track mood across the menstrual cycle, answer self-report surveys, and complete four blood draws.
Active Comparator
PMDD with sertraline 		Participants delegated to the "PMDD with sertraline" arm will be individuals with severe premenstrual symptoms in the luteal phase of the menstrual cycle. Participants will be asked to track mood across two menstrual cycles, answer self-report surveys, and complete eight blood draws (four in each menstrual cycle). In the second cycle, participants in this arm will take a daily pill of 50 mg of sertraline from ovulation until menses onset (end of menstrual cycle 2).
  • Drug: sertraline 50 mg daily
    The intervention will be in the form of an oral pill, taken daily, from the day of positive urine ovulation test result until the day of menses onset.
Placebo Comparator
PMDD with placebo 		Participants delegated to the "PMDD with placebo" arm will be individuals with severe premenstrual symptoms in the luteal phase of the menstrual cycle. Participants will be asked to track mood across two menstrual cycles, answer self-report surveys, and complete eight blood draws (four in each menstrual cycle). In the second cycle, participants in this arm will take a daily placebo pill from ovulation until menses onset (end of menstrual cycle 2).
  • Drug: Placebo Oral Tablet
    The placebo oral tablet will be of the same shape, color, and manufacturer as the sertraline 50 mg oral tablets. Tablet will be taken daily, from the day of positive urine ovulation test result until the day of menses onset.

Recruiting Locations

Reproductive Mental Health Center
Baltimore, Maryland 21205
Contact:
Victoria N Paone, B.S.
443-685-4258
vpaone1@jh.edu

University of Virginia
Charlottesville, Virginia 22903
Contact:
Lauren A Williamson, PhD
434-297-4689
LEA6D@uvahealth.org

More Details

NCT ID
NCT06704594
Status
Recruiting
Sponsor
Johns Hopkins University

Study Contact

Liisa Hantsoo, Doctor of Philosophy, PhD
215-645-7035
lhantso1@jhmi.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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