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Hormone Therapy

Transdermal Estradiol for Mental Illness (PEEPS Trial)

Phase 4
Recruiting
Led By Crystal E Schiller, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Stated willingness to comply with all study procedures, lifestyle considerations, and availability for the duration of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 3) to endpoint (week 7)
Awards & highlights

PEEPS Trial Summary

This trial will study the effects of a hormone on brain function in women experiencing early menopause symptoms.

Who is the study for?
This trial is for unmedicated perimenopausal women aged 44-55 with anhedonia or psychosis symptoms that started during menstrual irregularity. They must have a CGI-S score >3 and SHAPS scores >20, indicating significant symptoms, and be willing to follow the study procedures. Exclusions include psychiatric illness history before perimenopause, certain physical health conditions, current nicotine use, claustrophobia, BMI <18 or >35 kg/m^2.Check my eligibility
What is being tested?
The trial tests if estradiol affects brain function related to reward in women who developed anhedonia or psychosis during perimenopause. It involves PET-MR imaging to observe changes in brain activity after administering transdermal estradiol versus a placebo patch. Micronized progesterone and Raclopride C11 are also part of the interventions.See study design
What are the potential side effects?
Potential side effects may include skin irritation from patches, hormonal changes like mood swings or headaches due to estradiol or progesterone, and discomfort from imaging procedures. The specific risks associated with Raclopride C11 will depend on individual reactions but could involve allergic responses.

PEEPS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged 44-55, in late menopause transition, with irregular periods.
Select...
I am willing and able to follow all study rules and attend all appointments.
Select...
My psychosis severity is categorized based on my BPRS score.

PEEPS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 3) to endpoint (week 7)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 3) to endpoint (week 7) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Striatal Activation Between Groups during the MID task
Secondary outcome measures
Change in striatal phasic DA release and background DA tone to rewards measured by [11C]raclopride PET using the Monetary Incentive Delay (MID) task.
Changes in PO Anhedonia Following Estradiol Administration Using the SHAPS
Changes in PO Psychosis Symptoms following Estradiol Administration Using the BPRS

Side effects data

From 2015 Phase 4 trial • 65 Patients • NCT00030147
6%
Chest wall pain
6%
Pain in extremity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Raloxifene
Estradiol
Placebo
Rimostil

PEEPS Trial Design

8Treatment groups
Experimental Treatment
Group I: Perimenopausal women with mild-to-moderate anhedonia + moderate psychosis, placebo groupExperimental Treatment2 Interventions
Participants will be randomly assigned to receive a matching placebo patch for 3 weeks.
Group II: Perimenopausal women with mild-to-moderate anhedonia + moderate psychosis, active groupExperimental Treatment3 Interventions
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 III: Perimenopausal women with mild-to-moderate anhedonia + absent-to-mild psychosis, placebo groupExperimental Treatment2 Interventions
Participants will be randomly assigned to receive a matching placebo patch for 3 weeks.
Group IV: Perimenopausal women with mild-to-moderate anhedonia + absent-to-mild psychosis, active groupExperimental Treatment3 Interventions
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 V: Perimenopausal women with high anhedonia + moderate psychosis, placebo groupExperimental Treatment2 Interventions
Participants will be randomly assigned to receive a matching placebo patch for 3 weeks.
Group VI: Perimenopausal women with high anhedonia + moderate psychosis, active groupExperimental Treatment3 Interventions
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 VII: Perimenopausal women with high anhedonia + absent-to-mild psychosis, placebo groupExperimental Treatment2 Interventions
Participants will be randomly assigned to receive a matching placebo patch for 3 weeks.
Group VIII: Perimenopausal women with high anhedonia + absent-to-mild psychosis, active groupExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Progesterone
FDA approved
Estradiol
FDA approved
Matching Placebo Patch
2009
Completed Phase 4
~860

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,500 Previous Clinical Trials
4,186,615 Total Patients Enrolled
3 Trials studying Anhedonia
242 Patients Enrolled for Anhedonia
National Institute of Mental Health (NIMH)NIH
2,776 Previous Clinical Trials
2,673,657 Total Patients Enrolled
17 Trials studying Anhedonia
1,773 Patients Enrolled for Anhedonia
Crystal E Schiller, PhDPrincipal InvestigatorUNC School of Medicine - Department of Psychiatry
2 Previous Clinical Trials
43 Total Patients Enrolled

Media Library

Micronized Progesterone (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05282277 — Phase 4
Anhedonia Research Study Groups: Perimenopausal women with high anhedonia + moderate psychosis, placebo group, Perimenopausal women with mild-to-moderate anhedonia + moderate psychosis, placebo group, Perimenopausal women with high anhedonia + absent-to-mild psychosis, placebo group, Perimenopausal women with high anhedonia + moderate psychosis, active group, Perimenopausal women with mild-to-moderate anhedonia + absent-to-mild psychosis, placebo group, Perimenopausal women with mild-to-moderate anhedonia + moderate psychosis, active group, Perimenopausal women with mild-to-moderate anhedonia + absent-to-mild psychosis, active group, Perimenopausal women with high anhedonia + absent-to-mild psychosis, active group
Anhedonia Clinical Trial 2023: Micronized Progesterone Highlights & Side Effects. Trial Name: NCT05282277 — Phase 4
Micronized Progesterone (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05282277 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I able to participate in this clinical trial?

"This medical trial is accepting 103 individuals aged 44-55 who suffer from anhedonia. To be eligible for the study, applicants must provide a signed consent form and agree to adhere to all procedures outlined by the researchers. Additionally, participants should have missed at least two menstrual cycles within 60 days as well as present with clinically impairing levels of pleasure according to SHAPS scores and symptoms associated with psychosis based on BPRS testing. Lastly, they must also commit to adhering strictly to the estradiol regimen prescribed throughout the duration of this clinical project."

Answered by AI

Does the research team welcome participants who are septuagenarian or older?

"The minimum and maximum age for enrollment in this trial as stipulated by the inclusion criteria are 44 years old and 55 years old, respectively."

Answered by AI

Has the Federal Drug Administration authorized Transdermal Estradiol?

"Transdermal Estradiol has been approved, so its safety rating was given a 3 out of 3 by Power."

Answered by AI

What is the current enrollment size of this research project?

"Affirmative. Clinicaltrials.gov's information reveals that this trial, which was initially announced on April 1st 2022, is currently in the process of recruitment. Around 103 participants need to be enrolled from one medical site."

Answered by AI

Are there still openings for participants in this experiment?

"According to clinicaltrials.gov, this research endeavour is still searching for participants who meet the eligibility criteria. The trial was initially published on April 1st 2022 and underwent a revision as recently as April 21st 2022."

Answered by AI
Recent research and studies
~61 spots leftby Dec 2026