Actively Recruiting
Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression
Led by University of North Carolina, Chapel Hill · Updated on 2025-10-29
75
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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? And consequently, how does stabilizing the luteal phase decline in estrogen and progesterone (using estradiol patches and progesterone pills) affect these changes? Participants will: * Receive hormones followed by placebo, or vice versa, for a total of four weeks across three menstrual cycles * Complete daily mood ratings * Collect home urine samples for hormone testing * Complete five biobehavioral testing sessions during which neural responses are recorded (via electroencephalography, or EEG) during an acute stress task and computer tasks
CONDITIONS
Official Title
Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biologically female and between the ages of 18-45 years (to avoid perimenopause effects)
- Regular menstrual cycles lasting 25 to 35 days
- Previous diagnosis of major depressive disorder with self-reported worsening before menstruation
- If the participant has children, at least 1 year postpartum
- Able to speak English
You will not qualify if you...
- Pregnant, breastfeeding, or trying to become pregnant; pregnancy tests will be done at enrollment and before the second treatment condition
- Currently using any form of exogenous hormones or intrauterine device, or have stopped use less than one month before the study; must have had one normal menstrual period after stopping hormonal medications
- Body mass index (BMI) less than 18 or greater than 29
- Personal history of chronic medical conditions that could affect the study, including metabolic or autoimmune diseases, epilepsy, endometriosis, cancer, diabetes, cardiovascular, gastrointestinal, liver, kidney, lung diseases, migraine with aura, hypertension, Parkinson's disease, chronic pain, or blood clotting events
- Family history increasing risk of breast cancer or blood clots
- Current cigarette smoker
- History of mania, psychosis, or substance use disorder
- Recent active suicidal thoughts in the last 12 months or suicide attempt within the last 5 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27707
Actively Recruiting
Research Team
S
Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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