Examining the Effects of Estradiol on Neural and Molecular Response to Reward (NCT05282277) | Clinical Trial Compass
RecruitingPhase 4
Examining the Effects of Estradiol on Neural and Molecular Response to Reward
United States103 participantsStarted 2022-04-20
Plain-language 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).
Who can participate
Age range45 Years – 55 Years
SexFEMALE
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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.
* 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 psychotic subscale of the Brief Psychiatric Rating Scale (BPRS)
* 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% plasti…
What they're measuring
1
Changes in Striatal Activation Between Groups during the MID task