Examining the Effects of Estradiol on Neural and Molecular Response to Reward

Summary

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

• Depression
• Psychosis
• Anhedonia

Interventions

DRUG

Transdermal Estradiol

Participants will be randomized to receive transdermal estradiol (100μg/day) patch for 3 weeks.

DRUG

Micronized Progesterone

Participants will receive an additional week of micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

DRUG

Matching Placebo Patch

Participants will be randomized to receive a transdermal estradiol-matching placebo patch for 3 weeks

DRUG

Raclopride C11

All 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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Crystal E Schiller, PhD · UNC School of Medicine - Department of Psychiatry

• Gabriel Dichter, PhD · UNC School of Medicine - CIDD

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-20

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations