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Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression

Study acronym: PEAR
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary and study completion dates: Jul 1, 2026 to Jun 1, 2028 Site contact updatedv2 Show 1 more changeShow less
    • Site contact updated
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06610305
Lead Sponsor University of North Carolina, Chapel Hill
Collaborators: National Institute of Mental Health (NIMH)
Conditions Major Depressive Disorder
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov