RecruitingPhase 4NCT06610305

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

Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression: A Crossover Randomized Controlled Trial

Sponsor

University of North Carolina, Chapel Hill

Enrollment

75 participants

Start Date

Sep 2, 2024

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder

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

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating why some women with depression experience a significant worsening of their mood symptoms in the days before their period. Specifically, researchers want to understand how the drop in ovarian hormones at the end of the menstrual cycle affects mood, motivation (anhedonia — feeling no pleasure), and the brain's reward system. No experimental drug is being tested — this is a research study using brain scans and hormone monitoring. **You may be eligible if...** - You are biologically female and between 18 and 45 years old - You have regular menstrual cycles (25–35 days long) - You have a history of major depression and notice your symptoms get worse before your period - If you have children, at least 1 year has passed since giving birth - You speak English **You may NOT be eligible if...** - You are pregnant, breastfeeding, or trying to become pregnant - You are currently taking any hormonal medications or have an IUD - You have a condition that affects your hormones or menstrual cycle Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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