Actively Recruiting
Examining the Effects of Estradiol on Neural and Molecular Response to Reward
Led by University of North Carolina, Chapel Hill · Updated on 2026-04-29
103
Participants Needed
1
Research Sites
245 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Examining the Effects of Estradiol on Neural and Molecular Response to Reward
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to follow all study procedures and availability for study duration
- Women aged 44 to 55 years, unmedicated, in late perimenopause with 2 skipped menstrual cycles or amenorrhea 60 days (STRAW stage -1)
- Anhedonia or psychosis symptoms that began during menstrual irregularity
- Clinician's Global Impression Scale-Severity score greater than 3
- Snaith-Hamilton Pleasure Scale score above 20 indicating clinically significant anhedonia
- Stratification by psychosis severity using Brief Psychiatric Rating Scale
- Willingness to follow the estradiol treatment regimen
You will not qualify if you...
- Pregnancy or allergy to ingredients in Climara4 patch or Prometrium4
- Body mass index less than 18 or greater than 35 kg/m
- History of chronic menstrual irregularity lasting more than 1 year without menses
- Contraindications to MRI (metal implants, dental work beyond fillings or gold, tattoos, metal injury, non-plastic implants)
- More than one research study involving ionizing radiation exceeding 3 rem in past 12 months
- Use of psychotropic or hormonal medications
- Psychiatric illness within 2 years before perimenopause onset
- History of recurrent mood or psychotic episodes prior to perimenopause
- History of mood episodes requiring hospitalization
- Current mania or depressive episodes unrelated to menopause transition within past 2 years
- Suicide attempts within last year or active suicidal ideation with plan
- Neurological conditions such as seizures or traumatic brain injury
- Brain stimulation treatment in past 6 months
- Endometriosis
- Family history of premenopausal breast cancer or multiple family members with postmenopausal breast cancer
- Current use of medications affecting mood or frequent anti-inflammatory use
- Breastfeeding or trying to conceive
- Last menstrual period over 12 months prior to enrollment
- History of undiagnosed vaginal bleeding or ovarian enlargement
- Polycystic ovary syndrome
- Personal or family history of breast or ovarian cancer or BRCA mutations
- Porphyria, malignant melanoma, Hodgkin's disease
- Recurrent migraines with aura
- Gallbladder, pancreatic, heart, kidney, liver, or cerebrovascular disease
- Family history of heart attack or stroke
- Current nicotine use
- Claustrophobia
- Peanut allergy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
Research Team
K
Kathryn G Gibson, BS
CONTACT
L
Laura C Lundegard, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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