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NCT Number: NCT06704594

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

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.

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Key information

Conditions

Premenstrual Dysphoric Disorder (PMDD) Depressive Disorder Menstruation Disturbances Mental Disorders Mood Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Premenstrual Dysphoric Disorder Premenstrual Syndrome

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Reproductive Mental Health Center, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sertraline 50 mg daily

Drug

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 oral tablet

Drug

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 outcomes

  1. Neuroactive Steroid Levels

    Time frame: Post ovulation up to 2 days, up to 5 days pre-menses prediction

    The primary outcome variable is levels of neuroactive steroids in blood; from the early luteal phase (2 days post ovulation) compared to the late luteal phase (days 5 to 1 prior to predicted menses onset)

Secondary outcomes

  1. Neurosteroidogenic enzyme expression levels

    Time frame: First menstrual cycle, up to 3 months

    Neurosteroidogenic enzyme expression levels will be measured in the early luteal phase (2 days post ovulation) and the late luteal phase (days 5 to 1 prior to predicted menses onset). Levels will be compared between the healthy controls and PMDD groups at cycle 1, and between sertraline and placebo groups at cycle 2, respectively; between cycle 1 (first menstrual cycle when blood draws will be completed) and until the end of the participants' time on the study (2-3 months).

  2. GABAAR subunit expression levels

    Time frame: first menstrual cycle, up to 3 months

    GABAAR subunit expression will be measured in the early luteal phase (2 days post ovulation) and the late luteal phase (days 5 to 1 prior to predicted menses onset). The investigators will compare GABAAR subunit expression levels between controls and PMDD groups at L1, and between sertraline and placebo groups at L2, respectively; between cycle 1 (first menstrual cycle when blood draws will be completed) and until the end of the participants' time on the study (2-3 months)

Study contacts

Contact information is provided by the study sponsor or research team.

Victoria Paone, B.S.

CONTACT

[email protected]

4436854258

Victoria Seo, B.S.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: BLOOM

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Nov 26, 2024
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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