Effects of Hormonal Changes on Depression in Women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates how hormonal fluctuations during the menstrual cycle influence mood symptoms in women aged 18-45 with major depressive disorder that worsens premenstrually. Participants will receive either hormone treatments or placebos over three menstrual cycles while completing daily mood ratings and undergoing biobehavioral testing, including EEG assessments. The study aims to determine the impact of stabilizing hormone levels on the ability to experience pleasure and reward sensitivity in these women.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of North Carolina, Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Chris Sikes-Keilp, MD — University of North Carolina, Chapel Hill
• Study coordinator: Study Coordinator
• Email: pearstudy@unc.edu
• Phone: (919) 445-6814

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.