NCT02673606

Impact of Estrogen on Fear Extinction R61

The Influence of Estrogen on the Fear Extinction Network in Humans-R61

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The goal of this project is to examine how estrogen may influence the resting-state connectivity and the extinction-induced activation of the fear extinction network.

Detailed description

The aim of the study was to examine the influence of exogenous estrogen administration on the activation of the fear extinction network in women. Functional MRI data and psychophysiological indices were collected to test the influence of estrogen on women's ability to regulate conditioned fear responses. Women underwent a 3 day experimental paradigm using classical fear conditioning. The first day was conducted outside the scanner, while days 2 and 3 were done inside the fMRI scanner and tested fear extinction learning and recall in days 2 and 3, respectively. The estrogen (or placebo) pill was given just hours before extinction learning test on day 2. No followups were conducted after women completed the 3 day study.

Conditions

• Fear
• Fear; Examination, Phobic

Interventions

Type	Name	Description
DRUG	Estradiol 2Mg Tablet	one 2 mg dose of estradiol (obtained from Estrace® Tablets, 2.0 mg estradiol tablets, USP, Warner Chilcott),
DRUG	Estradiol 4Mg Tablet	two 2 mg pills estradiol(obtained from Estrace® Tablets, 2.0 mg estradiol tablets, USP, Warner Chilcott),
DRUG	Placebo Pills	inactive placebo pills

Timeline

• Start date: 2013-01-01
• Primary completion: 2019-04-15
• Completion: 2019-04-15
• First posted: 2016-02-04
• Last updated: 2020-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study