drugset / Trial / NCT06610305

Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression

NCT06610305

RandomizedCrossoverTriple-blindOther

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

Timeline

Start
2024-09-02
Primary completion
2028-06-01
Completion
2028-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Estradiol Other / unclassified 0.1 mg Other
Subject Progesterone Other / unclassified 100 mg Oral