Impact of Estrogen on Fear Extinction R61

Fear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02673606
• Other study ID #: 2007P000496
• Status: Completed
• Phase: Phase 1
• Start date: January 2013
• Est. completion date: April 15, 2019

Study information

• Verified date: July 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: April 15, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fear
• Fear; Examination, Phobic

Intervention

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

Locations

Country	Name	City	State
United States	NYU School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of exogenous administration of estradiol on the neural correlates of fear extinction	BOLD responses during fear extinction after taking estradiol or placebo	3 Days