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Estradiol for Perimenopausal-Onset Anhedonia and Psychosis (PEEPS)
NCT05282277Phase 4
Key facts
- Status
- Recruiting
- Start
- Apr 2022
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- University of North Carolina at Chapel Hill
- Drugs
- estradiol topical
- Conditions
- major depressive disorder (MDD)psychosisanhedonia ((none))
01
Overview
Phase 4, randomised, double-blind trial of estradiol topical in major depressive disorder (MDD), psychosis and anhedonia ((none)) (8 arms), sponsored by University of North Carolina at Chapel Hill. Primary endpoint: Changes in Striatal Activation Between Groups during the MID task at week 7. Started Apr 2022; status: recruiting.
02
Design
8 arms- Study design
- RandomizedDouble-blind
Mild-to-moderate anhedonia + absent-to-mild psychosis, active
Active treatment group with mild-to-moderate anhedonia and absent-to-mild psychosis
Mild-to-moderate anhedonia + absent-to-mild psychosis, placebo
Placebo group with mild-to-moderate anhedonia and absent-to-mild psychosis
Mild-to-moderate anhedonia + moderate psychosis, active
Active treatment group with mild-to-moderate anhedonia and moderate psychosis
Mild-to-moderate anhedonia + moderate psychosis, placebo
Placebo group with mild-to-moderate anhedonia and moderate psychosis
High anhedonia + absent-to-mild psychosis, active
Active treatment group with high anhedonia and absent-to-mild psychosis
High anhedonia + absent-to-mild psychosis, placebo
Placebo group with high anhedonia and absent-to-mild psychosis
2 more in the full profile.
03
Who it enrols
Unmedicated perimenopausal women (STRAW stage -1) aged 44-55 with clinically impairing anhedonia (SHAPS > 20) or psychosis symptoms that began during menstrual irregularity, excluding those with a history of chronic psychiatric illness, recent suicide attempts, or current use of psychotropics/hormonal preparations.
04
Endpoints
Primary
Changes in Striatal Activation Between Groups during the MID task
Secondary
Changes in PO Psychosis Symptoms following Estradiol Administration Using the BPRS
Changes in PO Anhedonia Following Estradiol Administration Using the SHAPS
Change in striatal phasic DA release and background DA tone to rewards
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