Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-25 @ 9:03 PM
Study NCT ID:
NCT00186056
Status:
COMPLETED
Last Update Posted:
2017-04-05
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Mifepristone in Refractory Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D015735', 'term': 'Mifepristone'}, {'id': 'D000073893', 'term': 'Sugars'}], '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': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'solvason@stanford.edu', 'phone': '650-723-8331', 'title': 'Brent Solvason', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Mifepristone', 'description': 'Patients received mifepristone for 6 days\n\nMifepristone: Glucocorticoid antagonist', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patients received placebo for 6 days\n\nMifepristone: Glucocorticoid antagonist', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hamilton Depression Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mifepristone', 'description': 'Patients received mifepristone for 6 days\n\nMifepristone: Glucocorticoid antagonist'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients received placebo for 6 days\n\nMifepristone: Glucocorticoid antagonist'}], 'classes': [{'categories': [{'measurements': [{'value': '18.75', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '19.68', 'spread': '5.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.26', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Interaction of HAMD \\* medication group F(2,26)=1.38, eta sq = .05'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 35 HAMD scores', 'description': 'Hamilton Depression Rating Scale. Minimum score of 0 (no depressive symptoms) to maximum of 68 (very severely depressed).\n\nOutcome Measure is reporting a Change from Baseline in HAMD scores, i.e., scores at Day 35 minus scores at Baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mifepristone', 'description': 'Patients received mifepristone for 6 days\n\nMifepristone: Glucocorticoid antagonist'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Patients received placebo for 6 days\n\nMifepristone: Glucocorticoid antagonist'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mifepristone', 'description': 'Patients received mifepristone for 6 days\n\nMifepristone: Glucocorticoid antagonist'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patients received placebo for 6 days\n\nMifepristone: Glucocorticoid antagonist'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.92', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '51.82', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '51.43', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-17', 'studyFirstSubmitDate': '2005-09-13', 'resultsFirstSubmitDate': '2016-10-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-17', 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Depression Rating Scale', 'timeFrame': 'Baseline and Day 35 HAMD scores', 'description': 'Hamilton Depression Rating Scale. Minimum score of 0 (no depressive symptoms) to maximum of 68 (very severely depressed).\n\nOutcome Measure is reporting a Change from Baseline in HAMD scores, i.e., scores at Day 35 minus scores at Baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to examine the effectiveness of mifepristone treatment in patients with refractory depression. Refractory depression is defined as clinical depression that is unimproved after treatment with at least 2 different antidepressants of adequate dose and time trial. Mifepristone will augment current medications.', 'detailedDescription': 'Study Procedures:\n\nThis study will be a double-blind placebo-controlled 5-week trial.\n\nThirty patients with treatment refractory major depression will be studied over a one year period. Patients will be screened for eligibility, no more than two weeks prior to enrollment, which will involve psychiatric interviews (including the SCID-Mini, HAM-D, BPRS, and CGI-S), a physical exam, and blood and urine analyses.\n\nClinical laboratory assessments include a serum pregnancy test (for all females), comprehensive blood count, comprehensive metabolic panel, lipid panel, fasting insulin, glucose tolerance test, urine toxicology, and electrocardiogram.\n\nIf subjects are found to be eligible, they will be asked return within two weeks of their eligibility screening visit to begin the study. Additionally, they will be asked to keep a diary of their sleep pattern for 1 week prior to entering the study and for the entire 5 week duration of the study.\n\nOn the day before beginning study medication (Study Day 0), patients will be administered the HAM-D, BPRS, CGI-S, CGI-I and neuropsychological tests, and vitals will be obtained. Patients will also undergo an afternoon blood draw, with a blood sample taken each hour beginning at 1:00PM and ending at 4:00PM, in order to assess baseline cortisol levels. Patients will then be given a 4-day supply of double-blind study medication (either 24 100mg mifepristone tablets or 24 placebo tablets) with instructions to self-administer 6 tablets each morning.\n\nPatients will return on Day 4 to have study staff check on medication adherence, take vitals, and assess any possible adverse events. Patients will then receive an additional 3-day supply of double-blind study medication (either 18 100mg mifepristone tablets or 18 placebo tablets with instructions to orally self-administer 3 tablets each morning.\n\nPatients will return on Day 7 to have study staff check on medication adherence, take vitals, and assess any possible adverse events. Patients will also repeat clinical laboratory assessments (including a serum pregnancy test for all females, comprehensive blood count, comprehensive metabolic panel, lipid panel, fasting insulin, glucose tolerance test, and urinary analysis) and ECG, and repeat the afternoon blood draw from 1:00PM to 4:00PM to assess cortisol levels. They will also be administered the HAM-D, BPRS, CGI-S, and CGI-I.\n\nPatients will return after one week (Day 14) for administration of the HAM-D, BPRS, CGI-S, CGI-I, and assessment of any possible adverse events, and vitals. Patients will also repeat the afternoon blood draw from 1:00PM to 4:00PM to assess cortisol levels.\n\nPatients will also return on Day 28 and Day 35 for administration of the HAM-D, BPRS, CGI-S, CGI-I, and assessment of any possible adverse events, and vitals. All female patients will undergo serum pregnancy testing on Day 35. In addition, all patients will be asked turn in their sleep diary to the research staff and will receive a neuropsychological test on day 35.\n\nDuring the study, patients will be monitored for adrenal insufficiency and signs of Cushingnoid effects by monitoring blood pressure, pre-treatment (eligibility) and post-treatment (Day 7) metabolic panels (including measures of glucose and potassium), and monitoring of any changes that occur during the study.\n\nWomen with child-bearing potential are required to use a double-barrier method to prevent pregnancy during the study and for 30 days after the study. The double-barrier method includes 2 of the following methods of contraception: spermicidal foam, condom diaphragm, or IUD. Women of child-bearing potential are defined as women, 18 years of age or older, who have not been diagnosed by their primary care physician or gynecologist with menopause, and who have an intact uterus. Women not of child-bearing potential are defined as women, 18 years of age or older, who are status post hysterectomy or have been diagnosed by their primary care physician or gynecologist with menopause (as clinically defined by examination and results of FSH/LH blood work).\n\nAfter the study, subjects will be referred for follow-up care as needed.\n\nSubjects will not be paid for their participation in this protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria::\n\n* 21-item HAM-D score of 20 or above.\n* If currently taking antipsychotic, antidepressant, anticonvulsant, and/or mood-stabilizing medications, must be stable on the medication for at least three weeks prior to entering the study.\n* At least 2 failed antidepressant medication trials of adequate dose and duration.\n* Between 18 and 75 years of age.\n* Not currently pregnant or trying to become pregnant. Exclusion Criteria:-History of schizophrenia or other psychotic disorders.\n* Transcranial magnetic stimulation treatment or ECT in the 3 months prior to starting the study.\n* History of vagus nerve stimulation treatment.\n* No unstable or untreated cardiovascular disease, hypertension, or endocrine disorder.\n* Current use of oral contraceptives or any other drug that may result in adverse drug-mifepristone interactions effects (including Amiodarone, Clarithromycin, Erythromycin, Fluconazole, Fluvoxamine, Indinavir, Intraconazole, Ketoconazole, Metronidazole, Miconazole, Nefazodone, Nelfinavir, Norfloxacin, Omeprazole, Quinine, Ritonavir, Saquinavir, Troleandomycin, Zafirlukast, Carbamazepine, Dexamethasone, Ethosuximide, Phenobarbital, Phenytoin, Primidone, Rifabutin, Rifampin, Troglitazone). A 30-day wash-out period for oral contraceptives is required before mifepristone begins.\n* Previous allergic reaction to mifepristone or drugs of similar chemical structure.'}, 'identificationModule': {'nctId': 'NCT00186056', 'briefTitle': 'Mifepristone in Refractory Depression', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Mifepristone in Refractory Depression', 'orgStudyIdInfo': {'id': '78804'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mifepristone', 'description': 'Patients received mifepristone for 6 days', 'interventionNames': ['Drug: Mifepristone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Patients received placebo for 6 days', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'Mifepristone', 'type': 'DRUG', 'otherNames': ['RU 486'], 'description': 'Glucocorticoid antagonist', 'armGroupLabels': ['Mifepristone']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'otherNames': ['sugar pill'], 'description': 'Inactive placebo tab', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Hugh Brent Solvason', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Hugh Brent Solvason', 'investigatorAffiliation': 'Stanford University'}}}}