Status:
RECRUITING
Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Major Depressive Disorder
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
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. T...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06610305
Start Date
September 2 2024
End Date
June 1 2028
Last Update
October 29 2025
Active Locations (1)
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1
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27707