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Completed

NCT Number: NCT02673606

Impact of Estrogen on Fear Extinction R61

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

NYU School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Right-handed (Edinburgh Inventory - Oldfield 1971).
  • SCID diagnosis consistent with none, current or past history of Axis I psychiatric disorders.
  • To be matched for age, gender, and years of education, as well as self-identified race/ethnicity.
  • For naturally cycling female subjects, stage of menstrual cycle will be ascertained by history, and by serological measures.
  • For women on oral contraceptives, we will identify those using 20mcg ethinyl, 2nd or 3rd generation, monophasic

Exclusion criteria

  • Psychiatric, neurologic or medical condition that would interfere with study procedures or confound results, ascertained by history.
  • History of seizure or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion).
  • History of Axis I psychiatric diagnosis; e.g., history of substance use disorder, psychotic disorder, bipolar disorder, tic disorder, or eating disorder.
  • Use of psychotropic medication within 4 weeks prior to study (within 6 weeks for fluoxetine, or other long-lived compounds; within one year for neuroleptics).
  • Pregnancy (to be ruled out by urine ß-HCG).
  • Metallic implants or devices contraindicating magnetic resonance imaging.
  • Use of oral contraceptives or non-oral contraceptives containing estrogen and progesterone within 3 months
  • History of breast cancer.
  • Allergy to peanut oil.

Treatment and study plan

Estradiol 2Mg Tablet

Drug

one 2 mg dose of estradiol (obtained from Estrace® Tablets, 2.0 mg estradiol tablets, USP, Warner Chilcott),

Other names: Estrace® Tablets

Estradiol 4Mg Tablet

Drug

two 2 mg pills estradiol(obtained from Estrace® Tablets, 2.0 mg estradiol tablets, USP, Warner Chilcott),

Other names: Estrace® Tablets

Placebo pills

Drug

inactive placebo pills

Other names: Estrace® Tablets

Primary outcomes

  1. Impact of exogenous administration of estradiol on the neural correlates of fear extinction

    Time frame: 3 Days

    BOLD responses during fear extinction after taking estradiol or placebo

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Feb 4, 2016
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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