Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2026-03-01 @ 10:51 PM
Study NCT ID:
NCT02673606
Status:
COMPLETED
Last Update Posted:
2020-07-30
First Post:
2016-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Estrogen on Fear Extinction R61
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'double blind placebo control study'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-29', 'studyFirstSubmitDate': '2016-01-26', 'studyFirstSubmitQcDate': '2016-02-01', 'lastUpdatePostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of exogenous administration of estradiol on the neural correlates of fear extinction', 'timeFrame': '3 Days', 'description': 'BOLD responses during fear extinction after taking estradiol or placebo'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fear', 'Fear; Examination, Phobic']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Right-handed (Edinburgh Inventory - Oldfield 1971).\n* SCID diagnosis consistent with none, current or past history of Axis I psychiatric disorders.\n* To be matched for age, gender, and years of education, as well as self-identified race/ethnicity.\n* For naturally cycling female subjects, stage of menstrual cycle will be ascertained by history, and by serological measures.\n* For women on oral contraceptives, we will identify those using 20mcg ethinyl, 2nd or 3rd generation, monophasic\n\nExclusion Criteria:\n\n* Psychiatric, neurologic or medical condition that would interfere with study procedures or confound results, ascertained by history.\n* History of seizure or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion).\n* History of Axis I psychiatric diagnosis; e.g., history of substance use disorder, psychotic disorder, bipolar disorder, tic disorder, or eating disorder.\n* 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).\n* Pregnancy (to be ruled out by urine ß-HCG).\n* Metallic implants or devices contraindicating magnetic resonance imaging.\n* Use of oral contraceptives or non-oral contraceptives containing estrogen and progesterone within 3 months\n* History of breast cancer.\n* Allergy to peanut oil.'}, 'identificationModule': {'nctId': 'NCT02673606', 'briefTitle': 'Impact of Estrogen on Fear Extinction R61', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'The Influence of Estrogen on the Fear Extinction Network in Humans-R61', 'orgStudyIdInfo': {'id': '2007P000496'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Estradiol 2mg Dose', 'description': '2mg dose of estradiol (oral administration)', 'interventionNames': ['Drug: Estradiol 2Mg Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Estradiol 4mg Dose', 'description': '4mg dose of estradiol (oral administration)', 'interventionNames': ['Drug: Estradiol 4Mg Tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo (oral administration)', 'interventionNames': ['Drug: Placebo Pills']}], 'interventions': [{'name': 'Estradiol 2Mg Tablet', 'type': 'DRUG', 'otherNames': ['Estrace® Tablets'], 'description': 'one 2 mg dose of estradiol (obtained from Estrace® Tablets, 2.0 mg estradiol tablets, USP, Warner Chilcott),', 'armGroupLabels': ['Estradiol 2mg Dose']}, {'name': 'Estradiol 4Mg Tablet', 'type': 'DRUG', 'otherNames': ['Estrace® Tablets'], 'description': 'two 2 mg pills estradiol(obtained from Estrace® Tablets, 2.0 mg estradiol tablets, USP, Warner Chilcott),', 'armGroupLabels': ['Estradiol 4mg Dose']}, {'name': 'Placebo Pills', 'type': 'DRUG', 'otherNames': ['Estrace® Tablets'], 'description': 'inactive placebo pills', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Mohammed Milad, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}