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Acute Effects of Estradiol Administration on Brain Function During Fear Learning

ConditionsPTSD and Trauma-related SymptomsCognitive Decline in Older AdultsPost Menopausal Women
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age60+
SponsorUniversity of Arizona

About this trial

The goal of current study is to better understand how fear is processed in the brain and how these processes are influenced by cognition and hormones. This research will focus specifically on postmenopausal female adults, because age-related changes in cognition and declining estrogen levels may contribute to anxiety symptoms and PTSD risk later in life.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

post-menopausal

normal or corrected-to-normal vision

English speaking

stable medication use (no changes in the past three months)

Disqualifiers

use of hormone therapy containing synthetic estrogen

MRI contraindications (e.g., irremovable ferrous metal in body, claustrophobia)

history of neurological disorder (including mild cognitive impairment) or moderate to severe traumatic brain injury

use of antipsychotic, opiate, or mood stabilizer (i.e., lithium) medication

Trial design

Design model

Single group

Treatments tested in this trial

  • estradiol

    Drug

    oral 2mg tablet of estradiol

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: EstradiolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Neural Response to Fear Conditioning Task

Estrogen has been shown to modulate the function of brain regions involved in fear processing, including the amygdala, hippocampus, and ventromedial prefrontal cortex. During fMRI, participants will complete a fear conditioning and generalization task to measure brain activity. They will view different neutral images of geometric shapes which may or may not predict the imminent receipt of an electric shock to the ankle. Across voxels of the brain, activation estimates (BOLD response) will be extracted for CS+ (conditioned threat) vs. CS- (conditioned safety) cues, and linear activation patterns across ambiguous generalization stimuli (i.e., GSs; CS+ \> GS1 \> GS2 \> GS3 \> CS-).

Time frame
single visit, approximately 4 hours after taking study drug

Secondary outcomes

1

Skin Conductance Response

Sweat glands activate under stress, increasing the electrical conductance of the skin. Participants will have electrodes attached on their palm to measure changes in sympathetic nervous system activity, providing an objective, physiological measure of anticipatory anxiety.

Time frame
single visit, approximately 4 hours after taking study drug
2

Subjective Fear and Risk Ratings

Self-report can be used to ascertain subjective fear and explicit knowledge of threat contingencies. Participants will be asked to rate of perceived risk of each displayed stimulus from 1 (no risk) to 3 (high risk), contingency learning, and aversiveness of the stimulation (1-5) during task completion in the scanner and after.

Time frame
single visit, approximately 4 hours after taking study drug

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Arizona

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: