Examining the Effects of Estradiol on Neural and Molecular Response to Reward
NCT ID: NCT05282277
Last Updated: 2025-02-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE4
Total Enrollment
103 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-04-20
Study Completion Date
2026-12-31
Brief Summary
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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).
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Detailed Description
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The transition to menopause (the "perimenopause") is characterized by increased risk for new onset of depression and psychosis. Our work and that of others has demonstrated that a prominent symptom of perimenopausal-onset (PO) depression is anhedonia, contributing significantly to distress and functional impairment. Additionally, the incidence of psychosis in women may increase during this period. Declining or low levels of estradiol, particularly in the late perimenopause, may play a role in the pathogenesis of PO anhedonia and PO psychosis via effects on mesolimbic brain reward circuitry and dopamine (DA) neurotransmission. Preclinical evidence has established that estradiol modulates dopamine systems and reward-related behaviors and estradiol withdrawal evokes loss of dopaminergic functions. Whereas estrogen therapy has shown benefits in reducing mood and psychotic symptoms in perimenopausal women, no study has examined the neural mechanisms underlying such effects in a transdiagnostic sample.
This project will examine the effects of estradiol administration on perimenopausal-onset (PO) anhedonia and psychosis using simultaneous positron emission tomography and functional magnetic resonance imaging (PET-MR). Preliminary data presented here demonstrate that anhedonia is associated with decreased striatal DA release to rewards using PET with the D2/D3 DA receptor antagonist \[11C\]raclopride; anhedonia and psychosis are characterized by altered striatal activation to rewards using fMRI; estradiol impacts neural responses to rewards in PO anhedonia and PO psychosis; and estradiol improves PO anhedonia and PO psychosis. This project proposes to extend these lines of research by using simultaneous PET-MR to investigate the effects of transdermal estradiol, administered as a mechanistic probe, on PO anhedonia and PO psychosis in a transdiagnostic sample of women using a double-blind between-groups placebo-controlled design. This sample will be enriched for anhedonia (i.e., at least mild anhedonia). Although anhedonia and psychosis will be analyzed dimensionally, our recruitment and stratification strategy will ensure that a range of symptom severities (mild-to-moderate or high PO anhedonia; absent-to-mild or moderate PO psychosis) are equally balanced and randomized to each experimental group (estradiol or placebo). Our central hypotheses are that the mesolimbic DA system is impaired in PO anhedonia and psychosis, that estradiol administration will normalize neural responses to rewards (measured by fMRI) and striatal DA functioning (measured by PET), and that the degree of change in striatal functioning will be associated with the degree of change in PO anhedonia and PO psychosis.
Specific Aim 1 (baseline associations between PO anhedonia, PO psychosis, and PET-MR): Characterize, at baseline, associations between PO anhedonia and PO psychosis symptom severity and reward-related striatal activation measured by fMRI, and tonic and phasic striatal DA activity measured by \[11C\]raclopride PET.
Specific Aim 2 (estradiol effects on PO anhedonia and PET-MR): Determine the effects of estradiol (vs. placebo) on PO anhedonia and changes in PET-MR metrics related to reward processing.
Specific Aim 3 (estradiol effects on PO psychosis and PET-MR): Determine the effects of estradiol (vs. placebo) on PO psychosis and changes in PET-MR metrics related to reward processing.
This project will improve our understanding of PO anhedonia and psychosis and the mechanisms of action of the effect of estradiol on PO anhedonia and psychosis. This research will provide new mechanistic endpoints to evaluate novel PO anhedonia and psychosis treatments that target the mesolimbic DA system.
This project will examine the effects of estradiol administration on perimenopausal-onset (PO) anhedonia and psychosis using simultaneous positron emission tomography and functional magnetic resonance imaging (PET-MR). Preliminary data presented here demonstrate that anhedonia is associated with decreased striatal DA release to rewards using PET with the D2/D3 DA receptor antagonist \[11C\]raclopride; anhedonia and psychosis are characterized by altered striatal activation to rewards using fMRI; estradiol impacts neural responses to rewards in PO anhedonia and PO psychosis; and estradiol improves PO anhedonia and PO psychosis. This project proposes to extend these lines of research by using simultaneous PET-MR to investigate the effects of transdermal estradiol, administered as a mechanistic probe, on PO anhedonia and PO psychosis in a transdiagnostic sample of women using a double-blind between-groups placebo-controlled design. This sample will be enriched for anhedonia (i.e., at least mild anhedonia). Although anhedonia and psychosis will be analyzed dimensionally, our recruitment and stratification strategy will ensure that a range of symptom severities (mild-to-moderate or high PO anhedonia; absent-to-mild or moderate PO psychosis) are equally balanced and randomized to each experimental group (estradiol or placebo). Our central hypotheses are that the mesolimbic DA system is impaired in PO anhedonia and psychosis, that estradiol administration will normalize neural responses to rewards (measured by fMRI) and striatal DA functioning (measured by PET), and that the degree of change in striatal functioning will be associated with the degree of change in PO anhedonia and PO psychosis.
Specific Aim 1 (baseline associations between PO anhedonia, PO psychosis, and PET-MR): Characterize, at baseline, associations between PO anhedonia and PO psychosis symptom severity and reward-related striatal activation measured by fMRI, and tonic and phasic striatal DA activity measured by \[11C\]raclopride PET.
Specific Aim 2 (estradiol effects on PO anhedonia and PET-MR): Determine the effects of estradiol (vs. placebo) on PO anhedonia and changes in PET-MR metrics related to reward processing.
Specific Aim 3 (estradiol effects on PO psychosis and PET-MR): Determine the effects of estradiol (vs. placebo) on PO psychosis and changes in PET-MR metrics related to reward processing.
This project will improve our understanding of PO anhedonia and psychosis and the mechanisms of action of the effect of estradiol on PO anhedonia and psychosis. This research will provide new mechanistic endpoints to evaluate novel PO anhedonia and psychosis treatments that target the mesolimbic DA system.
Conditions
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Depression
Psychosis
Anhedonia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Parallel group, randomized placebo-controlled study
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Study Groups
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Perimenopausal women with mild-to-moderate anhedonia + absent-to-mild psychosis, active group
Participants 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.
Group Type
EXPERIMENTAL
Transdermal Estradiol
Intervention Type
DRUG
Participants will be randomized to receive transdermal estradiol (100μg/day) patch for 3 weeks.
Micronized Progesterone
Intervention Type
DRUG
Participants will receive an additional week of micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.
Raclopride C11
Intervention Type
DRUG
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.
Perimenopausal women with mild-to-moderate anhedonia + absent-to-mild psychosis, placebo group
Participants will be randomly assigned to receive a matching placebo patch for 3 weeks.
Group Type
EXPERIMENTAL
Matching Placebo Patch
Intervention Type
DRUG
Participants will be randomized to receive a transdermal estradiol-matching placebo patch for 3 weeks
Raclopride C11
Intervention Type
DRUG
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.
Perimenopausal women with mild-to-moderate anhedonia + moderate psychosis, active group
Participants 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.
Group Type
EXPERIMENTAL
Transdermal Estradiol
Intervention Type
DRUG
Participants will be randomized to receive transdermal estradiol (100μg/day) patch for 3 weeks.
Micronized Progesterone
Intervention Type
DRUG
Participants will receive an additional week of micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.
Raclopride C11
Intervention Type
DRUG
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.
Perimenopausal women with mild-to-moderate anhedonia + moderate psychosis, placebo group
Participants will be randomly assigned to receive a matching placebo patch for 3 weeks.
Group Type
EXPERIMENTAL
Matching Placebo Patch
Intervention Type
DRUG
Participants will be randomized to receive a transdermal estradiol-matching placebo patch for 3 weeks
Raclopride C11
Intervention Type
DRUG
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.
Perimenopausal women with high anhedonia + absent-to-mild psychosis, active group
Participants 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.
Group Type
EXPERIMENTAL
Transdermal Estradiol
Intervention Type
DRUG
Participants will be randomized to receive transdermal estradiol (100μg/day) patch for 3 weeks.
Micronized Progesterone
Intervention Type
DRUG
Participants will receive an additional week of micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.
Raclopride C11
Intervention Type
DRUG
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.
Perimenopausal women with high anhedonia + absent-to-mild psychosis, placebo group
Participants will be randomly assigned to receive a matching placebo patch for 3 weeks.
Group Type
EXPERIMENTAL
Matching Placebo Patch
Intervention Type
DRUG
Participants will be randomized to receive a transdermal estradiol-matching placebo patch for 3 weeks
Raclopride C11
Intervention Type
DRUG
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.
Perimenopausal women with high anhedonia + moderate psychosis, active group
Participants 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.
Group Type
EXPERIMENTAL
Transdermal Estradiol
Intervention Type
DRUG
Participants will be randomized to receive transdermal estradiol (100μg/day) patch for 3 weeks.
Micronized Progesterone
Intervention Type
DRUG
Participants will receive an additional week of micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.
Raclopride C11
Intervention Type
DRUG
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.
Perimenopausal women with high anhedonia + moderate psychosis, placebo group
Participants will be randomly assigned to receive a matching placebo patch for 3 weeks.
Group Type
EXPERIMENTAL
Matching Placebo Patch
Intervention Type
DRUG
Participants will be randomized to receive a transdermal estradiol-matching placebo patch for 3 weeks
Raclopride C11
Intervention Type
DRUG
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.
Interventions
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Transdermal Estradiol
Participants will be randomized to receive transdermal estradiol (100μg/day) patch for 3 weeks.
Intervention Type
DRUG
Micronized Progesterone
Participants will receive an additional week of micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.
Intervention Type
DRUG
Matching Placebo Patch
Participants will be randomized to receive a transdermal estradiol-matching placebo patch for 3 weeks
Intervention Type
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.
Intervention Type
DRUG
Other Intervention Names
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Climara
Prometrium
Placebo
[C11]Raclopride
Eligibility Criteria
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Inclusion Criteria
* 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.
* Willingness to adhere to the estradiol regimen
* 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.
* Willingness to adhere to the estradiol regimen
Exclusion Criteria
* 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).
* A history of mood episodes requiring hospitalization.
* Current mania;
* Depressive episode(s) within 2 years of enrollment not associated with the transition to menopause;
* A history of suicide attempts within the last year or current active suicidal ideation with intent and plan.
* Neurological conditions (e.g., history of seizure or TBI)
* Brain stimulation treatment in the past six months.
* Endometriosis;
* First degree relative with premenopausal breast cancer or breast cancer presenting in both breasts or multiple family members (greater than three relatives) with postmenopausal breast cancer.
* Current medication use (i.e., current psychotropics, current anti-hypertensives, current statins, current hormonal preparations, or frequent use of anti-inflammatory agents (\> 10 times/month)). Women will be allowed to enroll who take medications without known mood effects (e.g. stable thyroid hormone replacement and occasional (\< 5 times/month) use of Ambien)\*;
* Pregnant, breastfeeding or trying to conceive;
* Last menstrual period more than 12 months prior to enrollment;
* History of undiagnosed vaginal bleeding;
* Undiagnosed enlargement of the ovaries;
* Polycystic ovary syndrome;
* History of breast or ovarian cancer;
* First degree relative with ovarian cancer;
* Abnormal finding in a provider breast exam and/or mammogram;
* Known carrier of BRCA1 or 2 mutation;
* Porphyria;
* Malignant melanoma;
* Hodgkin's disease;
* Recurrent migraine headaches that are preceded by aura;
* Gallbladder or pancreatic disease\*\*;
* Heart or kidney disease\*\*;
* Liver disease;
* cerebrovascular disease (stroke);
* First degree relative with history of heart attack or stroke;
* Current nicotine use;
* Self-reported claustrophobia
* Peanut allergy
* all reported prescription medications will be reviewed and cleared by a study physician prior to a participant's enrollment;
* participants will be given the opportunity to describe these conditions in the online screening survey. Reported conditions that are acute in nature and/or benign will be reviewed by a study physician and exclusions will be decided case-by-case. All chronic conditions will be exclusionary. For those where it is deemed that an exclusion does not apply, primary analyses will not be affected, but exploratory analyses will be conducted excluding these individuals
* 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).
* A history of mood episodes requiring hospitalization.
* Current mania;
* Depressive episode(s) within 2 years of enrollment not associated with the transition to menopause;
* A history of suicide attempts within the last year or current active suicidal ideation with intent and plan.
* Neurological conditions (e.g., history of seizure or TBI)
* Brain stimulation treatment in the past six months.
* Endometriosis;
* First degree relative with premenopausal breast cancer or breast cancer presenting in both breasts or multiple family members (greater than three relatives) with postmenopausal breast cancer.
* Current medication use (i.e., current psychotropics, current anti-hypertensives, current statins, current hormonal preparations, or frequent use of anti-inflammatory agents (\> 10 times/month)). Women will be allowed to enroll who take medications without known mood effects (e.g. stable thyroid hormone replacement and occasional (\< 5 times/month) use of Ambien)\*;
* Pregnant, breastfeeding or trying to conceive;
* Last menstrual period more than 12 months prior to enrollment;
* History of undiagnosed vaginal bleeding;
* Undiagnosed enlargement of the ovaries;
* Polycystic ovary syndrome;
* History of breast or ovarian cancer;
* First degree relative with ovarian cancer;
* Abnormal finding in a provider breast exam and/or mammogram;
* Known carrier of BRCA1 or 2 mutation;
* Porphyria;
* Malignant melanoma;
* Hodgkin's disease;
* Recurrent migraine headaches that are preceded by aura;
* Gallbladder or pancreatic disease\*\*;
* Heart or kidney disease\*\*;
* Liver disease;
* cerebrovascular disease (stroke);
* First degree relative with history of heart attack or stroke;
* Current nicotine use;
* Self-reported claustrophobia
* Peanut allergy
* all reported prescription medications will be reviewed and cleared by a study physician prior to a participant's enrollment;
* participants will be given the opportunity to describe these conditions in the online screening survey. Reported conditions that are acute in nature and/or benign will be reviewed by a study physician and exclusions will be decided case-by-case. All chronic conditions will be exclusionary. For those where it is deemed that an exclusion does not apply, primary analyses will not be affected, but exploratory analyses will be conducted excluding these individuals
Minimum Eligible Age
45 Years
Maximum Eligible Age
55 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Sponsor Role
collaborator
University of North Carolina, Chapel Hill
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Crystal E Schiller, PhD
Role: PRINCIPAL_INVESTIGATOR
UNC School of Medicine - Department of Psychiatry
Gabriel Dichter, PhD
Role: PRINCIPAL_INVESTIGATOR
UNC School of Medicine - CIDD
Locations
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21-2230
Identifier Type: -
Identifier Source: org_study_id
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