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Recruiting NCT06704594

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

Phase IV Interventional Premenstrual Dysphoric Disorder (PMDD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: sertraline 50 mg daily, Placebo Oral Tablet.
Who it may be relevant to
Registry conditions: Premenstrual Dysphoric Disorder (PMDD). Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Neuroactive Steroid Levels [Time frame: Post ovulation up to 2 days, up to 5 days pre-menses prediction]
Secondary outcome measures (2)
  • Neurosteroidogenic enzyme expression levels [Time frame: First menstrual cycle, up to 3 months]
  • GABAAR subunit expression levels [Time frame: first menstrual cycle, up to 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Reproductive Mental Health Center — Baltimore
  • University of Virginia — Charlottesville

Identifiers

NCT: NCT06704594 · IRB00445770 · R01MH134904

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗