NCT06610305 Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression
| NCT ID | NCT06610305 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2024-09-02 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 75 participants in total. It began in 2024-09-02 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 at the first visit of the second condition. Women will be instructed to use a barrier method of birth control during the study. * Taking any form of exogenous hormones or IUD, and must have ended previous use of hormonal preparations at least one month prior to the study. Women who were previously taking oral contraceptives or other hormonal medications must have one normal menstrual cycle (menstrual period) prior to enrollment in the study. * BMI less than 18 or greater than 29. * A personal history of any chronic medical condition that could confound the experimental protocol, including but not limited to metabolic or autoimmune disease, epilepsy, endometriosis, cancer, diabetes, cardiovascular, gastrointestinal, hepatic, renal, pulmonary disease, migraine with aura, hypertension, Parkinson's disease, chronic pain, and thromboembolic events. * A family history indicative of increased risk of breast cancer or thromboembolic disorders. * Current cigarette smoking. * A history of mania, psychosis, or substance use disorder. * Any recent history (last 12 months) of active suicidal ideation, or suicide attempt within the last 5 years.
Contact & Investigator
Chris Sikes-Keilp, MD
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT06610305 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06610305 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06610305 currently recruiting?
Yes, NCT06610305 is actively recruiting participants. Contact the research team at pearstudy@unc.edu for enrollment information.
Where is the NCT06610305 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06610305 clinical trial?
NCT06610305 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Chris Sikes-Keilp, MD at University of North Carolina, Chapel Hill. The trial plans to enroll 75 participants.