Health Trials

Examining the Effects of Estradiol on Neural and Molecular Response to Reward

ConditionsDepressionPsychosisAnhedonia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age45-55
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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

Qualifiers

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.

Disqualifiers

Pregnancy; allergies to any active or inactive ingredients in the Climara® patch or Prometrium®.

BMI < 18 or > 35 kg/m²

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% plastic.

Trial design

Treatments tested in this trial

  • Transdermal Estradiol
  • Micronized Progesterone
  • Matching Placebo Patch
  • Raclopride C11

Treatment groups

103 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Locations

1
University of North Carolina at Chapel Hill27514, Chapel HillNorth Carolina, United States

Sponsors and collaborators

University of North Carolina, Chapel Hill

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov