Examining the Effects of Estradiol on Neural and Molecular Response to Reward
Part of paid clinical trials in Chapel Hill, North Carolina.
- Sponsor
- University of North Carolina, Chapel Hill
- Study ID
- NCT05282277
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Anhedonia
- Depression
- Psychosis
Eligibility Criteria
- Sex
- FEMALE
- Age
- 45 Years - 55 Years
- Healthy Volunteers
- Not accepted
Interventions
- Transdermal Estradiol — DRUGParticipants will be randomized to receive transdermal estradiol (100μg/day) patch for 3 weeks.
- Micronized Progesterone — DRUGParticipants will receive an additional week of micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.
- Matching Placebo Patch — DRUGParticipants will be randomized to receive a transdermal estradiol-matching placebo patch for 3 weeks
- Raclopride C11 — DRUGAll Participants will receive two PET-MR scans using \[11C\]raclopride IV as the tracer. The first scan will occur at baseline and the second at post treatment after 3 weeks.
Study Details
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).
Key Dates
- Start date
- Apr 20, 2022
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 103 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Perimenopausal women with mild-to-moderate anhedonia + absent-to-mild psychosis, active groupParticipants will be randomly assigned to take 100 μg/day of transdermal estradiol for 3 weeks followed by 1 week of combined 100 μg/day of transdermal estradiol and 200 mg/day progesterone.
- Experimental: Perimenopausal women with mild-to-moderate anhedonia + absent-to-mild psychosis, placebo groupParticipants will be randomly assigned to receive a matching placebo patch for 3 weeks.
- Experimental: Perimenopausal women with mild-to-moderate anhedonia + moderate psychosis, active groupParticipants will be randomly assigned to take 100 μg/day of transdermal estradiol for 3 weeks followed by 1 week of combined 100 μg/day of transdermal estradiol and 200 mg/day progesterone.
- Experimental: Perimenopausal women with mild-to-moderate anhedonia + moderate psychosis, placebo groupParticipants will be randomly assigned to receive a matching placebo patch for 3 weeks.
- Experimental: Perimenopausal women with high anhedonia + absent-to-mild psychosis, active groupParticipants will be randomly assigned to take 100 μg/day of transdermal estradiol for 3 weeks followed by 1 week of combined 100 μg/day of transdermal estradiol and 200 mg/day progesterone.
- Experimental: Perimenopausal women with high anhedonia + absent-to-mild psychosis, placebo groupParticipants will be randomly assigned to receive a matching placebo patch for 3 weeks.
- Experimental: Perimenopausal women with high anhedonia + moderate psychosis, active groupParticipants will be randomly assigned to take 100 μg/day of transdermal estradiol for 3 weeks followed by 1 week of combined 100 μg/day of transdermal estradiol and 200 mg/day progesterone.
- Experimental: Perimenopausal women with high anhedonia + moderate psychosis, placebo groupParticipants will be randomly assigned to receive a matching placebo patch for 3 weeks.
Primary Outcome Measure
Changes in Striatal Activation Between Groups during the MID task [ Time Frame: Baseline (week 3) to Endpoint (week 7) ]
Central Contacts
- Kathryn G Gibson, BS919-966-5243
- Laura C Lundegard, BA919-966-5243
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 |
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