Phase 4 Depression and Anxiety Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who are biologically female and between 18 and 45 years old.
- People who have regular menstrual cycles that last between 25 and 35 days, based on self-report.
- People who have previously been diagnosed with major depressive disorder and report that their symptoms get worse in the days before their period.
- People who have children must be at least one year past giving birth before joining.
- People who speak English.
Who may not be able to join:
- People who are currently pregnant, breastfeeding, or trying to become pregnant. (A urine pregnancy test will be done at the enrollment visit and again at the start of the second part of the study.)
- People who are currently using any form of hormonal treatment, including hormonal birth control or a hormonal IUD. Previous use of these must have ended at least one month before the study, and at least one normal menstrual period must have occurred after stopping hormonal medications before enrolling.
- People whose BMI is below 18 or above 29.
- People who have a personal history of certain ongoing health conditions that could affect the study, including (but not limited to) metabolic or autoimmune diseases, epilepsy, endometriosis, cancer, diabetes, heart disease, digestive conditions, liver or kidney disease, lung disease, migraines with aura, high blood pressure, Parkinson's disease, chronic pain, or blood clot-related conditions.
- People with a family history that suggests a higher-than-normal risk of breast cancer or blood clot disorders.
- People who currently smoke cigarettes.
- People who have a history of mania, psychosis, or a substance use disorder.
- People who have had active thoughts of suicide in the past 12 months, or a suicide attempt in the past 5 years.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Chris Sikes-Keilp, MD, University of North Carolina, Chapel Hill
Phone: (919) 445-6814
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Dimensional Anhedonia Rating Scale (Luteal Phase Stabilized vs Luteal Phase Unstabilized Hormones vs Follicular Phase); Reward Positivity (Luteal Phase Stabilized vs Luteal Phase Unstabilized Hormones vs Follicular Phase)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.