Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-28 @ 12:05 AM
Study NCT ID:
NCT00637494
Status:
TERMINATED
Last Update Posted:
2017-06-05
First Post:
2008-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features
Sponsor:
Organization:
Raw JSON
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{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 41, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 32, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychotic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Mifepristone vs. Placebo Treated Patients With at Least a 50% Reduction From Baseline in Brief Psychiatric Rating Scale-Positive Symptom Subscale (BPRS-PSS) at Days 7 and 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'Mifepristone followed by an antidepressant\n\nmifepristone: 1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo followed by an antidepressant\n\nplacebo: Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '56 days', 'description': 'Response as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group administered mifepristone', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Mifepristone Treated Patients With Plasma Drug Concentrations Equal to or Above 1637 ng/mL vs. Placebo Treated Patients Who Achieve a ≤ 50% Reduction in BPRS-PSS at Days 7 and 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'Mifepristone followed by an antidepressant\n\nmifepristone: 1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo followed by an antidepressant\n\nplacebo: Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '56 days', 'description': 'Response as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group who achieved a sufficiently high plasma level of mifepristone', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mifepristone 1200 mg/Day', 'description': 'Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56'}, {'id': 'FG001', 'title': 'Matching Placebo', 'description': 'Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '108'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '43'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mifepristone Followed by an Antidepressant', 'description': 'Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56'}, {'id': 'BG001', 'title': 'Matching Placebo', 'description': 'Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.4', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '47.0', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '46.2', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}}, 'statusModule': {'whyStopped': 'DRC recommended stopping study as it had missed its primary endpoint', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2008-03-11', 'resultsFirstSubmitDate': '2016-12-23', 'studyFirstSubmitQcDate': '2008-03-12', 'lastUpdatePostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-23', 'studyFirstPostDateStruct': {'date': '2008-03-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Mifepristone vs. Placebo Treated Patients With at Least a 50% Reduction From Baseline in Brief Psychiatric Rating Scale-Positive Symptom Subscale (BPRS-PSS) at Days 7 and 56', 'timeFrame': '56 days', 'description': 'Response as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group administered mifepristone'}], 'secondaryOutcomes': [{'measure': 'Proportion of Mifepristone Treated Patients With Plasma Drug Concentrations Equal to or Above 1637 ng/mL vs. Placebo Treated Patients Who Achieve a ≤ 50% Reduction in BPRS-PSS at Days 7 and 56', 'timeFrame': '56 days', 'description': 'Response as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group who achieved a sufficiently high plasma level of mifepristone'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['psychotic depression', 'major depression with psychotic features', 'psychosis'], 'conditions': ['Psychotic Depression', 'Severe Major Depression With Psychotic Features', 'Psychosis']}, 'referencesModule': {'references': [{'pmid': '16889757', 'type': 'BACKGROUND', 'citation': 'DeBattista C, Belanoff J, Glass S, Khan A, Horne RL, Blasey C, Carpenter LL, Alva G. Mifepristone versus placebo in the treatment of psychosis in patients with psychotic major depression. Biol Psychiatry. 2006 Dec 15;60(12):1343-9. doi: 10.1016/j.biopsych.2006.05.034. Epub 2006 Aug 4.'}, {'pmid': '16160710', 'type': 'BACKGROUND', 'citation': 'Flores BH, Kenna H, Keller J, Solvason HB, Schatzberg AF. Clinical and biological effects of mifepristone treatment for psychotic depression. Neuropsychopharmacology. 2006 Mar;31(3):628-36. doi: 10.1038/sj.npp.1300884.'}, {'pmid': '12242054', 'type': 'BACKGROUND', 'citation': 'Belanoff JK, Rothschild AJ, Cassidy F, DeBattista C, Baulieu EE, Schold C, Schatzberg AF. An open label trial of C-1073 (mifepristone) for psychotic major depression. Biol Psychiatry. 2002 Sep 1;52(5):386-92. doi: 10.1016/s0006-3223(02)01432-4.'}, {'pmid': '11593077', 'type': 'BACKGROUND', 'citation': 'Belanoff JK, Flores BH, Kalezhan M, Sund B, Schatzberg AF. Rapid reversal of psychotic depression using mifepristone. J Clin Psychopharmacol. 2001 Oct;21(5):516-21. doi: 10.1097/00004714-200110000-00009.'}, {'pmid': '29523415', 'type': 'DERIVED', 'citation': 'Block TS, Kushner H, Kalin N, Nelson C, Belanoff J, Schatzberg A. Combined Analysis of Mifepristone for Psychotic Depression: Plasma Levels Associated With Clinical Response. Biol Psychiatry. 2018 Jul 1;84(1):46-54. doi: 10.1016/j.biopsych.2018.01.008. Epub 2018 Jan 31.'}], 'seeAlsoLinks': [{'url': 'http://www.corcept.com', 'label': 'Corcept Therapeutics'}]}, 'descriptionModule': {'briefSummary': 'Approximately 450 patients will be randomized to receive mifepristone or placebo for 7 days followed by antidepressant. The purpose is to compare the efficacy of mifepristone followed by antidepressant versus placebo followed by antidepressant in reducing psychotic symptoms in patients with a diagnosis of psychotic depression.', 'detailedDescription': 'Up to 450 patients with psychotic depression will be randomly assigned to receive either mifepristone or matching placebo. Patients will be assessed by the investigator or site staff during screening and on study days. A single antidepressant selected from a list of approved drugs will be administered after the administration of investigational drug. Adverse events, laboratory assessments, electrocardiograms, and physical examinations will be used to assess safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have provided written consent to participate in the study prior to any study procedures and understand that they are free to withdraw from the study at any time. Patients must be able to read and understand the consent form, complete study-related procedures, and communicate with the study staff\n* Have a DSM-IV TR diagnosis of Major Depressive Disorder with Psychotic Features (DSM-IV 296.24 or 296.34), and are clinically symptomatic with their illness\n* Have pre-specified minimum scores on standardized psychiatric rating scales at baseline\n* Have not been taking excluded medication for at least 7 days prior to randomization\n* Have a negative pregnancy test\n* If not postmenopausal for ≥ 2 years or surgically sterile (6 months post-surgery), must consent (patient or partner) to utilize two medically acceptable methods of contraception, one of which is a barrier method, throughout the entire study period and for 3 months after the study is completed\n\nExclusion Criteria:\n\n* Have any primary psychiatric diagnosis other than psychotic depression.\n* Have a major medical problem, which in the opinion of the investigator would place the patient at undue risk.\n* Have undergone electroconvulsive therapy within 3 months prior to randomization\n* Have had a hospitalization due to a suicide attempt within 45 days prior to randomization\n* Are female and of childbearing age, and are unable or unwilling to use two medically acceptable methods of contraception during the study and for three months after study completion, one of which must be a barrier method\n* Are female and are pregnant or lactating\n* Are currently taking excluded medications\n* Have used drugs of abuse within 30 days prior to screen, as per patient report and urine drug screen\n* Have a history of active drug or alcohol abuse within 3 months or dependence within 6 months prior to screening\n* Are in the opinion of the investigator at immediate risk of suicide, or at risk of harming others\n* Have received investigational therapy (drug, vaccine, biological agent or device) within 6 months prior to randomization\n* Have previously participated in a clinical trial of mifepristone\n* Have a history of an allergic reaction to mifepristone\n* Are in the investigator's opinion not appropriate for participation in the study or may not be capable of following the study schedule for any reason\n* Are patients who are employees of the study unit or their family members, students who are working in the study unit, or family members of the investigator or Corcept Therapeutics"}, 'identificationModule': {'nctId': 'NCT00637494', 'briefTitle': 'A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corcept Therapeutics'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Mifepristone vs. Placebo in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features', 'orgStudyIdInfo': {'id': 'C-1073-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Mifepristone followed by an antidepressant', 'interventionNames': ['Drug: mifepristone']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo followed by an antidepressant', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'mifepristone', 'type': 'DRUG', 'otherNames': ['Korlym'], 'description': '1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['control'], 'description': 'Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72201', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'K&S Professional Research Services, LLC', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 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