Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2026-01-06 @ 2:36 AM
Study NCT ID:
NCT04148261
Status:
WITHDRAWN
Last Update Posted:
2021-10-06
First Post:
2019-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epinephrine and Cortisol 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'}, {'id': 'C036526', 'term': 'epinephrine sulfate'}, {'id': 'D004837', 'term': 'Epinephrine'}], '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'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, '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': 0}}, 'statusModule': {'whyStopped': 'Principal Investigator left lab before study start', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2019-10-30', 'studyFirstSubmitQcDate': '2019-10-30', 'lastUpdatePostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging', 'timeFrame': '2 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'This study investigates the effects of two hormones called epinephrine and cortisol on how the brain processes emotional material using functional MRI to measure brain activity. The study hopes to learn how epinephrine and cortisol affect the brain differently in depressed and non-depressed individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Weight of less than 280 pounds\n* HAM-D Score of greater than 7 for depression participants\n\nExclusion Criteria:\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 or cataracts\n* Chronic expressed infections (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* Diabetes\n* Any cardiovascular disease (angina, hypovolemia, coronary artery disease, low/high blood pressure, etc)\n* Any pulmonary disease\n* Any cerebrovascular disease\n* Sulfate hypersensitivity\n* Glaucoma\n* Infection\n* Pregnancy\n* Parkinson's Disease\n* Panic Disorder\n* Over 280 pounds in weight\n* In-dwelling ferrous metals\n* Left handed\n* Abnormal hearing\n* Claustrophobic\n* Head injury with loss of consciousness\n* Active suicidal ideation"}, 'identificationModule': {'nctId': 'NCT04148261', 'briefTitle': 'Epinephrine and Cortisol in Depression', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'The Effects of Epinephrine and Cortisol on Emotion in Depression', 'orgStudyIdInfo': {'id': '53325'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Arm, CORT + EPI, then PLB + EPI', 'description': 'Healthy participant will receive cortisol pill and epinephrine infusion', 'interventionNames': ['Drug: Hydrocortisone Acetate (CORT)', 'Drug: Epinephrine Sulfate (EPI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Arm, PLB + EPI, then CORT + EPI', 'description': 'Healthy participant will receive placebo pill and epinephrine infusion', 'interventionNames': ['Drug: Epinephrine Sulfate (EPI)', 'Drug: Placebo (PLB)']}, {'type': 'EXPERIMENTAL', 'label': 'Depression Arm, CORT + EPI, then PLB + EPI', 'description': 'Depressed participant will receive cortisol pill and epinephrine infusion', 'interventionNames': ['Drug: Hydrocortisone Acetate (CORT)', 'Drug: Epinephrine Sulfate (EPI)']}, {'type': 'EXPERIMENTAL', 'label': 'Depression Arm, PLB + EPI, then CORT + EPI', 'description': 'Depressed participant will receive placebo pill and epinephrine infusion', 'interventionNames': ['Drug: Epinephrine Sulfate (EPI)', 'Drug: Placebo (PLB)']}], 'interventions': [{'name': 'Hydrocortisone Acetate (CORT)', 'type': 'DRUG', 'otherNames': ['Cortef'], 'description': 'Participants will receive a single dose of hydrocortisone at a dosage of 0.65 mg/kg', 'armGroupLabels': ['Depression Arm, CORT + EPI, then PLB + EPI', 'Healthy Arm, CORT + EPI, then PLB + EPI']}, {'name': 'Epinephrine Sulfate (EPI)', 'type': 'DRUG', 'otherNames': ['Adrenalin'], 'description': 'Participants will receive a continuous infusion of epinephrine at a dosage of 80 ng/kg/min', 'armGroupLabels': ['Depression Arm, CORT + EPI, then PLB + EPI', 'Depression Arm, PLB + EPI, then CORT + EPI', 'Healthy Arm, CORT + EPI, then PLB + EPI', 'Healthy Arm, PLB + EPI, then CORT + EPI']}, {'name': 'Placebo (PLB)', 'type': 'DRUG', 'description': 'Participants will receive a placebo', 'armGroupLabels': ['Depression Arm, PLB + EPI, then CORT + EPI', 'Healthy Arm, PLB + EPI, then CORT + EPI']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Keith Sudheimer, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}