Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-01-02 @ 2:16 AM
Study NCT ID:
NCT02837432
Status:
COMPLETED
Last Update Posted:
2021-10-22
First Post:
2016-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Cortisol Administration on Neural Correlates of Emotion in Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C021650', 'term': 'hydrocortisone acetate'}, {'id': 'D006854', 'term': 'Hydrocortisone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-14', 'studyFirstSubmitDate': '2016-07-15', 'studyFirstSubmitQcDate': '2016-07-18', 'lastUpdatePostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging.', 'timeFrame': '2 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression', 'Cortisol', 'Sadness', 'Genetics', 'Stress'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'There is good evidence to suggest that the pathological version of sadness that people with Major Depression experience could be caused by the failure of the hormone cortisol to properly inhibit sadness-related brain activity in the subgenual cingulate cortex. This project investigates if the subgenual cingulate cortex has become insensitive to cortisol in patients with depression and tests for variants of the cortisol receptor genes that could predispose individuals to develop cortisol insensitivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'https://redcap.stanford.edu/surveys/?s=3F7WCENPND\n\nInclusion Criteria:\n\n* Healthy Participants must have no Axis 1 mental disorder\n* Participants with depression must meet minimum severity levels (Hamilton \\>7)\n* All participants must weight less than 280 pounds for the purposes of MRI scanning\n\nExclusion Criteria:\n\nIn order to protect against risk associated with taking Hydrocortisone, all participants must not have any of the following:\n\n* Psychotropic medications\n* Recent surgery\n* Endocrine disorders\n* Liver disease\n* Kidney disease\n* Thyroid disorder\n* History of malaria\n* Tuberculosis\n* Osteoporosis\n* Glaucoma/cataracts\n* Chronic expressed infections (herpes --including ocular herpes, HIV, etc.)\n* History of congestive heart failure\n* History of recurring seizures\n* Stomach Ulcers\n* Comorbid psychosis\n* Current use of illicit drugs\n* High Blood pressure\n\nIn order to protect against risks associated with MRI scanning participants must not be/have any of the following:\n\n* \\>280 lbs\n* In-dwelling ferrous metals\n* Left Handed\n* Abnormal Hearing\n* Claustrophobic\n* Head injury with loss of consciousness'}, 'identificationModule': {'nctId': 'NCT02837432', 'briefTitle': 'The Effect of Cortisol Administration on Neural Correlates of Emotion in Depression', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'The Effect of Cortisol Administration on Neural Correlates of Emotion in Depression', 'orgStudyIdInfo': {'id': '19771'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy', 'description': 'Healthy individuals will receive both the placebo and hydrocortisone interventions in a randomized order', 'interventionNames': ['Drug: Hydrocortisone acetate', 'Drug: Placebo']}, {'type': 'OTHER', 'label': 'Depression', 'description': 'Individuals with depression will receive both the placebo and hydrocortisone interventions in a randomized order', 'interventionNames': ['Drug: Hydrocortisone acetate', 'Drug: Placebo']}], 'interventions': [{'name': 'Hydrocortisone acetate', 'type': 'DRUG', 'otherNames': ['Cortef'], 'armGroupLabels': ['Depression', 'Healthy']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Depression', 'Healthy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Department of Psychiatry and Behavioral Sciences, 401 Quarry Road', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Keith Sudheimer, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Keith Sudheimer', 'investigatorAffiliation': 'Stanford University'}}}}