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RECRUITING
NCT06610305
PHASE4

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

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

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

Interventions

DRUG

Transdermal estradiol

0.1 mg/day delivered via weekly patch

DRUG

Progesterone

100 mg twice daily (200 mg/day total) administered via oral capsule

DRUG

Transdermal placebo patch

Once weekly via transdermal patch

DRUG

placebo capsule

Twice daily via oral capsule

Locations (1)

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States