Impact of Estrogen on Fear Extinction R61

NYU Langone Health

Status and phase: Completed; Phase 1

Conditions: Fear; Fear; Examination, Phobic

Treatments: Drug: Estradiol 2Mg Tablet; Drug: Placebo Pills; Drug: Estradiol 4Mg Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT02673606

2007P000496

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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136 participants in 3 patient groups, including a placebo group

Estradiol 2mg Dose

Experimental group

Description:

2mg dose of estradiol (oral administration)

Treatment:

Drug: Estradiol 2Mg Tablet

Estradiol 4mg Dose

Experimental group

Description:

4mg dose of estradiol (oral administration)

Treatment:

Drug: Estradiol 4Mg Tablet

Placebo

Placebo Comparator group

Description:

placebo (oral administration)

Treatment:

Drug: Placebo Pills