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Transdermal Estradiol for Psychosis

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of North Carolina at Chapel Hill, Chapel Hill, NCPsychosis+2 MoreTransdermal Estradiol - Drug
Eligibility
45 - 55
Female
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Study Summary

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

Eligible Conditions
  • Psychosis
  • Anhedonia
  • Depression

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Similar Trials

1
Oral Estradiol
1
Rivastigmine Transdermal Product
1
Flutamide

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Baseline (week 3) to Endpoint (week 7)

Week 7
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
Changes in Striatal Activation Between Groups during the MID task

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Oral Estradiol
1
Rivastigmine Transdermal Product
1
Flutamide

Side Effects for

Estradiol
6%Rash maculo-papular
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT00030147) in the Estradiol ARM group. Side effects include: Rash maculo-papular with 6%.

Trial Design

8 Treatment Groups

Perimenopausal women with high anhedonia + moderate psychosis, placebo group
1 of 8
Perimenopausal women with mild-to-moderate anhedonia + moderate psychosis, place...
1 of 8
Perimenopausal women with high anhedonia + absent-to-mild psychosis, placebo gro...
1 of 8
Perimenopausal women with high anhedonia + moderate psychosis, active group
1 of 8
Perimenopausal women with mild-to-moderate anhedonia + absent-to-mild psychosis,...
1 of 8
Perimenopausal women with mild-to-moderate anhedonia + moderate psychosis, activ...
1 of 8
Perimenopausal women with mild-to-moderate anhedonia + absent-to-mild psychosis,...
1 of 8
Perimenopausal women with high anhedonia + absent-to-mild psychosis, active grou...
1 of 8

Experimental Treatment

103 Total Participants · 8 Treatment Groups

Primary Treatment: Transdermal Estradiol · Has Placebo Group · Phase 4

Perimenopausal women with high anhedonia + moderate psychosis, placebo groupExperimental Group · 2 Interventions: Matching Placebo Patch, Raclopride C11 · Intervention Types: Drug, Drug
Perimenopausal women with mild-to-moderate anhedonia + moderate psychosis, placebo groupExperimental Group · 2 Interventions: Matching Placebo Patch, Raclopride C11 · Intervention Types: Drug, Drug
Perimenopausal women with high anhedonia + absent-to-mild psychosis, placebo groupExperimental Group · 2 Interventions: Matching Placebo Patch, Raclopride C11 · Intervention Types: Drug, Drug
Perimenopausal women with high anhedonia + moderate psychosis, active groupExperimental Group · 3 Interventions: Micronized Progesterone, Transdermal Estradiol, Raclopride C11 · Intervention Types: Drug, Drug, Drug
Perimenopausal women with mild-to-moderate anhedonia + absent-to-mild psychosis, placebo groupExperimental Group · 2 Interventions: Matching Placebo Patch, Raclopride C11 · Intervention Types: Drug, Drug
Perimenopausal women with mild-to-moderate anhedonia + moderate psychosis, active groupExperimental Group · 3 Interventions: Micronized Progesterone, Transdermal Estradiol, Raclopride C11 · Intervention Types: Drug, Drug, Drug
Perimenopausal women with mild-to-moderate anhedonia + absent-to-mild psychosis, active groupExperimental Group · 3 Interventions: Micronized Progesterone, Transdermal Estradiol, Raclopride C11 · Intervention Types: Drug, Drug, Drug
Perimenopausal women with high anhedonia + absent-to-mild psychosis, active groupExperimental Group · 3 Interventions: Micronized Progesterone, Transdermal Estradiol, Raclopride C11 · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Micronized Progesterone
2014
N/A
~1380
Transdermal Estradiol
2002
Completed Phase 4
~70
Matching Placebo Patch
2009
Completed Phase 4
~860

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (week 3) to endpoint (week 7)

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,379 Previous Clinical Trials
3,928,941 Total Patients Enrolled
6 Trials studying Psychosis
515 Patients Enrolled for Psychosis
National Institute of Mental Health (NIMH)NIH
2,584 Previous Clinical Trials
1,984,709 Total Patients Enrolled
40 Trials studying Psychosis
7,292 Patients Enrolled for Psychosis
Crystal E Schiller, PhDPrincipal InvestigatorUNC School of Medicine - Department of Psychiatry
2 Previous Clinical Trials
72 Total Patients Enrolled
Gabriel Dichter, PhDPrincipal InvestigatorUNC School of Medicine - CIDD
2 Previous Clinical Trials
46 Total Patients Enrolled

Eligibility Criteria

Age 45 - 55 · Female Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have experienced loss of interest or pleasure in activities or have had symptoms of psychosis during a time when you had irregular periods.
You are a woman between the ages of 44-55 who has missed at least two menstrual cycles or not had a period for at least 60 days, indicating the start of menopause. You cannot be currently taking medication for menopausal symptoms.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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