Impact of Estrogen on Fear Extinction R61

NCT ID: NCT02673606

Last Updated: 2020-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2019-04-15

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.

Conditions

Fear; Fear; Examination, Phobic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Estradiol 2mg Dose

2mg dose of estradiol (oral administration)

Group Type: EXPERIMENTAL

Estradiol 2Mg Tablet

Intervention Type: DRUG

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

Estradiol 4mg Dose

4mg dose of estradiol (oral administration)

Group Type: EXPERIMENTAL

Estradiol 4Mg Tablet

Intervention Type: DRUG

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

Placebo

placebo (oral administration)

Group Type: PLACEBO_COMPARATOR

Placebo Pills

Intervention Type: DRUG

inactive placebo pills

Interventions

Estradiol 2Mg Tablet

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

Intervention Type: DRUG

Estradiol 4Mg Tablet

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

Intervention Type: DRUG

Placebo Pills

inactive placebo pills

Intervention Type: DRUG

Other Intervention Names

Estrace® Tablets; Estrace® Tablets; Estrace® Tablets

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohammed Milad, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

NYU School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

2007P000496

Identifier Type: -

Identifier Source: org_study_id