Clinical trial NCT02673606: Impact of Estrogen on Fear Extinction R61
Official title: The Influence of Estrogen on the Fear Extinction Network in Humans-R61
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fear
Fear; Examination, Phobic
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-02-04
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Impact of exogenous administration of estradiol on the neural correlates of fear extinction
timeFrame: 3 Days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Mohammed Milad, PhD
role: PRINCIPAL_INVESTIGATOR
References: