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NCT06704594RECRUITINGIRB Ready

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

(BLOOM)

Sponsored by Johns Hopkins University

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

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
History of arrythmias, severe liver impairment, history of seizure disorder
If currently taking the following meds: methylene blue, linezolid
Other prohibited concomi

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

288 participants

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Age Range

18 Years - 50 Years

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Gender

FEMALE

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Sponsor

Johns Hopkins University

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Baltimore

Maryland

Location available
View Baltimore location page
RECRUITING

Charlottesville

Virginia

Location available
View Charlottesville location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Premenstrual Dysphoric Disorder Treatment in Baltimore?

Join others in Maryland exploring innovative treatment options through clinical research

Premenstrual Dysphoric Disorder Treatment Options in Baltimore, Maryland

If you're searching for Premenstrual Dysphoric Disorder treatment in Baltimore, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Baltimore, Charlottesville and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Premenstrual Dysphoric Disorder. All study-related care is provided at no cost to participants.

Local Sites
2 locations in Maryland
Now Enrolling
Up to 288 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Premenstrual Dysphoric Disorder?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Premenstrual Dysphoric Disorder

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Premenstrual Dysphoric Disorder Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06704594. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.