Fear, Fear; Examination, Phobic
Conditions
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.
Interventions
DRUGEstradiol 2Mg Tablet
one 2 mg dose of estradiol (obtained from Estrace® Tablets, 2.0 mg estradiol tablets, USP, Warner Chilcott),
DRUGEstradiol 4Mg Tablet
two 2 mg pills estradiol(obtained from Estrace® Tablets, 2.0 mg estradiol tablets, USP, Warner Chilcott),
DRUGPlacebo Pills
inactive placebo pills
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
double blind placebo control study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed