Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression: A Crossover Randomized Controlled Trial
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
Description
Potential participants will first be screened over the phone to assess health history (including mental health) and reproductive status. Those who meet inclusion/exclusion criteria will be invited to an in-person enrollment session. At enrollment, consent will be obtained and participants will complete a structured interview and a series of questionnaires. Interested participants will be educated on the use of smartphone-based ecological momentary assessment (EMA) surveys, which will be used to complete daily mood ratings over the course of the study. Following enrollment, women will complete…
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Biologically female and between the ages of 18-45 years (45 set as upper limit to avoid endocrine changes associated with perimenopause). * Self-reported regular menstrual cycles between 25 and 35 days. * A previous diagnosis of major depressive disorder, with self-reported premenstrual worsening of symptoms. * If the woman has children, she must be at least 1 year postpartum. * English-speaking Exclusion Criteria: * Pregnant, breastfeeding, or trying to become pregnant. Pregnancy status will be confirmed using a urine pregnancy test at the enrollment visit and again a…
Interventions
- DrugTransdermal estradiol
0.1 mg/day delivered via weekly patch
- DrugProgesterone
100 mg twice daily (200 mg/day total) administered via oral capsule
- DrugTransdermal placebo patch
Once weekly via transdermal patch
- Drugplacebo capsule
Twice daily via oral capsule
Location
- University of North Carolina, Chapel HillChapel Hill, North Carolina