RecruitingDepressionPsychosisAnhedonia
Examining the Effects of Estradiol on Neural and Molecular Response to Reward
Eligible age
45–55 yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
This proposal will examine the effects of estradiol administration on perimenopausal-onset (PO) anhedonia and psychosis symptoms as well as on brain function using simultaneous positron emission tomography and functional magnetic resonance imaging (PET-MR).
Sponsor: University of North Carolina, Chapel Hill
You may qualify if…
- ✓ Provision of signed and dated informed consent form
- ✓ Stated willingness to comply with all study procedures, lifestyle considerations, and availability for the duration of the study
- ✓ 44-55 years old unmedicated perimenopausal women who have ≥ 2 skipped menstrual cycles, amenorrhea ≥ 60 days, corresponding to the late menopause transition (Stages of Reproductive Aging Workshop (STRAW stage -1).
- ✓ Anhedonia or psychosis symptoms that began during the period of menstrual irregularity.
- ✓ Clinician's Global Impression Scale-Severity score (CGI-S) \> 3 to confirm a clinically impaired sample.
- ✓ Anhedonia severity inclusion criteria and stratification: All participants will have Snaith-Hamilton Pleasure Scale (SHAPS) scores \> 20 consistent with the NIMH Fast-Fail Trial for Mood and Anxiety Disorders, corresponding to clinically impairing anhedonia.
- ✓ Psychosis severity inclusion criteria and stratification: Participants will be stratified according to scores on the psychotic subscale of the Brief Psychiatric Rating Scale (BPRS)
- ✓ Willingness to adhere to the estradiol regimen
You may not qualify if…
- ✕ Pregnancy; allergies to any active or inactive ingredients in the Climara® patch or Prometrium®.
- ✕ BMI \< 18 or \> 35 kg/m\^2
- ✕ A history of chronic menstrual cycle irregularity, meaning \> 1 year without menses
- ✕ MR contraindications: Metal in the body, dental work other than fillings or gold, tattoos, metal injury, any other implant unless they are 100% plastic.
- ✕ PET contradictions: participation in \>1 research study in the past 12 months that included ionizing radiation exceeding 3 rem to the whole body (e.g., PET, CT). Standard of care imaging is not exclusionary.
- ✕ The use of psychotropics or hormonal preparations.
- ✕ History of psychiatric illness during the 2 years before the onset of perimenopause.
- ✕ History of chronic, recurrent mood or psychotic disorders (i.e., more than one non-reproductive-related mood episode prior to the perimenopausal index episode).
Where it's recruiting
North Carolina
Chapel Hill
Source: ClinicalTrials.gov · NCT05282277 · last updated 2026-04-29