NCT05282277 Examining the Effects of Estradiol on Neural and Molecular Response to Reward
| NCT ID | NCT05282277 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 103 participants |
| Start Date | 2022-04-20 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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Brief 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).
Eligibility Criteria
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. * Anhedonia severity inclusion criteria and stratification: All participants will have Snaith-Hamilton Pleasure Scale (SHAPS) scores \> 20 consistent with the NIMH Fast-Fail Trial for Mood and Anxiety Disorders, corresponding to clinically impairing anhedonia. * Psychosis severity inclusion criteria and stratification: Participants will be stratified according to scores on the ps
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