Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-01-01 @ 1:51 AM
Study NCT ID:
NCT00128505
Status:
COMPLETED
Last Update Posted:
2012-02-15
First Post:
2005-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An International Extension Study of Corlux for Recurrent Psychotic Symptoms in Psychotic Major Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Serbia and Montenegro']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015735', 'term': 'Mifepristone'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-14', 'studyFirstSubmitDate': '2005-08-08', 'studyFirstSubmitQcDate': '2005-08-08', 'lastUpdatePostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and tolerability of Corlux (mifepristone) for the treatment of recurrent psychotic symptoms with major depression with psychotic features (PMD) who previously participated in Corcept Therapeutics Protocol C-1073-09'}], 'secondaryOutcomes': [{'measure': 'To assess the frequency of retreatment with Corlux in patients with PMD and qualitatively describe the psychotic symptoms for which retreatment is clinically indicated'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PMD', 'Depression', 'Psychosis', 'Psychotic Major Depression', 'Major Depression'], 'conditions': ['Major Depressive Disorder', 'Psychotic Disorders']}, 'referencesModule': {'references': [{'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': '7682909', 'type': 'BACKGROUND', 'citation': 'Brogden RN, Goa KL, Faulds D. Mifepristone. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential. Drugs. 1993 Mar;45(3):384-409. doi: 10.2165/00003495-199345030-00007.'}, {'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.'}], 'seeAlsoLinks': [{'url': 'http://www.corcept.com', 'label': 'Corcept Therapeutics'}]}, 'descriptionModule': {'briefSummary': "Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol. Under normal conditions, cortisol and other hormones are created by the body in response to physical and emotional stress, triggering a healthy stress response. People who suffer from psychotic major depression may have unusually high levels of cortisol circulating within them or abnormal patterns of cortisol levels, overloading the stress response mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If Corlux can keep the body's cortisol receptors from being overloaded, the stress response system may return to normal function, which may result in improvement of symptoms. The purpose of this study is to allow patients who have already participated in an earlier 8 week study of Corlux versus placebo (an inactive pill) to receive additional courses of treatment with Corlux periodically if a psychotic episode should reappear during a period of one year."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completed participation through Day 56 in Corcept Therapeutics Protocol C-1073-09\n* Are 18 to 75 years of age\n* Have a diagnosis of major depressive disorder with psychotic features (DSM-IV 296.24 or 296.34)\n* Are able to provide written informed consent\n\nExclusion Criteria:\n\n* Have a major medical problem\n* Have a history of an allergic reaction to CORLUX (C-1073, mifepristone)'}, 'identificationModule': {'nctId': 'NCT00128505', 'briefTitle': 'An International Extension Study of Corlux for Recurrent Psychotic Symptoms in Psychotic Major Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corcept Therapeutics'}, 'officialTitle': 'An International, Open-Label Extension Study of the Safety and Tolerability of CORLUX™ (Mifepristone) for Recurrent Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features', 'orgStudyIdInfo': {'id': 'C-1073-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mifepristone', 'interventionNames': ['Drug: Mifepristone']}], 'interventions': [{'name': 'Mifepristone', 'type': 'DRUG', 'armGroupLabels': ['mifepristone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Georgy Koychev M.D.', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Luchezar G Hranov M.D.', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Svetlozar H Haralanov Ph.D.', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Vihra Milanova M.D.', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Varna', 'country': 'Bulgaria', 'facility': 'Georgi Popov M.D.', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'city': 'Osijek', 'country': 'Croatia', 'facility': 'Pavo Filakovic M.D./Ph.D.', 'geoPoint': {'lat': 45.55066, 'lon': 18.6942}}, {'city': 'Rijeka', 'country': 'Croatia', 'facility': 'Ljiljana Moro M.D./Ph.D.', 'geoPoint': {'lat': 45.32673, 'lon': 14.44241}}, {'city': 'Split', 'country': 'Croatia', 'facility': 'Goran Dodig M.D./Ph.D.', 'geoPoint': {'lat': 43.50891, 'lon': 16.43915}}, {'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Dubravka Kocijan-Hercigonja M.D.', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Miro Jakovljevic M.D.', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Vera Folnegovic-Smalc M.D/Ph.D', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Mihai Dumitru Gheorge', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Târgu Mureş', 'country': 'Romania', 'facility': 'Aurel Nirestean M.D./Ph.D', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Ivana Timotijevic M.D.', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Jelena Martinovic M.D.', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Vladimir Diligenski M.D.', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Vladimir Paunovic M.D.', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Kragujevac', 'country': 'Serbia', 'facility': 'Dragana Ignjatovic-Ristic M.D.', 'geoPoint': {'lat': 44.01667, 'lon': 20.91667}}, {'city': 'Novi Sad', 'country': 'Serbia', 'facility': 'Ratomir Lisulov M.D.', 'geoPoint': {'lat': 45.25167, 'lon': 19.83694}}], 'overallOfficials': [{'name': 'Katherine Beebe, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Corcept Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corcept Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}