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New treatment option for Premenstrual Dysphoric Disorder (PMDD)
Official title Allopregnanolone and Dynamic GABA-A Receptor Plasticity in Selective Serotonin Reuptake Inhibitor Responsive Premenstrual Dysphoric Disorder
ClinicalTrials.gov ID: NCT06704594
What this study is testing
What is sertraline 50 mg daily?
sertraline 50 mg daily is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for premenstrual dysphoric disorder (pmdd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only. Healthy volunteers may be eligible.
You may be able to join if
- female sex,
- fluent in the English language
- regular menstrual cycles (24-35 days)
- age 18-50 years old
- ability to give written informed consent
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.