Impact of Estrogen on Fear Extinction R61

Phase 1

Completed

• Conditions: Fear; Fear; Examination, Phobic
• Interventions: Drug: Estradiol 4Mg Tablet; Drug: Estradiol 2Mg Tablet; Drug: Placebo Pills

• Registration Number: NCT02673606
• Lead Sponsor: NYU Langone Health

Brief 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-04
• Primary Completion: 2019-04-15
• Study Completion: 2019-04-15
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 136

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Estradiol 4mg Dose	Estradiol 4Mg Tablet	4mg dose of estradiol (oral administration)
Estradiol 2mg Dose	Estradiol 2Mg Tablet	2mg dose of estradiol (oral administration)
Placebo	Placebo Pills	placebo (oral administration)

Primary Outcome Measures

Name	Time	Method
Impact of exogenous administration of estradiol on the neural correlates of fear extinction	3 Days	BOLD responses during fear extinction after taking estradiol or placebo

Trial Locations

Locations (1)

NYU School of Medicine; 🇺🇸 New York, New York, United States