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Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression
Sponsor: University of North Carolina, Chapel Hill
Summary
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
Official title: Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression: A Crossover Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2024-09-02
Completion Date
2028-06-01
Last Updated
2025-10-29
Healthy Volunteers
No
Conditions
Interventions
Transdermal estradiol
0.1 mg/day delivered via weekly patch
Progesterone
100 mg twice daily (200 mg/day total) administered via oral capsule
Transdermal placebo patch
Once weekly via transdermal patch
placebo capsule
Twice daily via oral capsule
Locations (1)
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States