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New treatment option for Major Depressive Disorder
Official title Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression
ClinicalTrials.gov ID: NCT06610305
What this study is testing
What is Transdermal estradiol?
Transdermal estradiol is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for major depressive disorder.
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
- The goal of this clinical trial is to learn how hormonal changes over the menstrual cycle affect mood symptoms in reproductive-aged women with depression that worsens during the premenstrual period. The main questions it aims to answer are: --How do fluctuations in estradiol and progesterone across the menstrual cycle affect the ability to experience pleasure and the neural sensitivity to reward in hormone-sensitive, depressed women?
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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 45, women only
You may be able to join if
- Biologically female and between the ages of 18-45 years (45 set as upper limit to avoid endocrine changes associated with perimenopause).
- Self-reported regular menstrual cycles between 25 and 35 days.
- A previous diagnosis of major depressive disorder, with self-reported premenstrual worsening of symptoms.
- If the woman has children, she must be at least 1 year postpartum.
- English-speaking
You likely can't join if
- Pregnant, breastfeeding, or trying to become pregnant. Pregnancy status will be confirmed using a urine pregnancy test at the enrollment visit and...
- Taking any form of exogenous hormones or IUD, and must have ended previous use of hormonal preparations at least one month prior to the study. Women...
- BMI less than 18 or greater than 29.
- A personal history of any chronic medical condition that could confound the experimental protocol, including but not limited to metabolic or...
- A family history indicative of increased risk of breast cancer or thromboembolic disorders.
- Current cigarette smoking.
See the full eligibility criteria
- Biologically female and between the ages of 18-45 years (45 set as upper limit to avoid endocrine changes associated with perimenopause).
- Self-reported regular menstrual cycles between 25 and 35 days.
- A previous diagnosis of major depressive disorder, with self-reported premenstrual worsening of symptoms.
- If the woman has children, she must be at least 1 year postpartum.
- English-speaking
- Pregnant, breastfeeding, or trying to become pregnant. Pregnancy status will be confirmed using a urine pregnancy test at the enrollment visit and again at the first visit of the second condition. Women will be...
- Taking any form of exogenous hormones or IUD, and must have ended previous use of hormonal preparations at least one month prior to the study. Women who were previously taking oral contraceptives or other hormonal...
- BMI less than 18 or greater than 29.
- A personal history of any chronic medical condition that could confound the experimental protocol, including but not limited to metabolic or autoimmune disease, epilepsy, endometriosis, cancer, diabetes, cardiovascular...
- A family history indicative of increased risk of breast cancer or thromboembolic disorders.
- Current cigarette smoking.
- A history of mania, psychosis, or substance use disorder.
- Any recent history (last 12 months) of active suicidal ideation, or suicide attempt within the last 5 years.
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, 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 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, 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.