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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 56 day study is to learn the safety and effectiveness of Corlux in patients who have been diagnosed with psychotic major depression (PMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mifepristone 600 mg | Experimental |
| |
| matching placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The change in a measure of psychosis | screening and on Days 0, 7, 14, 28, 42, and 56 |
| Measure | Description | Time Frame |
|---|---|---|
| The change in a measure of depression | screening and on Days 0, 7, 14, 28, 42, and 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Beebe, PhD | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgy Koychev M.D. | Sofia | Bulgaria | ||||
| Luchezar G Hranov M.D. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12242054 | Background | 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. | |
| 7682909 | Background | 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. |
| Label | URL |
|---|---|
| Corcept Therapeutics | View source |
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|
| Sofia |
| Bulgaria |
| Svetlozar H Haralanov Ph.D. | Sofia | Bulgaria |
| Vihra Milanova M.D. | Sofia | Bulgaria |
| Georgi Popov M.D. | Varna | Bulgaria |
| Pavo Filakovic M.D./Ph.D. | Osijek | Croatia |
| Ljiljana Moro M.D./Ph.D. | Rijeka | Croatia |
| Goran Dodig M.D./Ph.D. | Split | Croatia |
| Dubravka Kocijan-Hercigonja M.D. | Zagreb | Croatia |
| Miro Jakovljevic M.D. | Zagreb | Croatia |
| Vera Folnegovic-Smalc M.D./Ph.D. | Zagreb | Croatia |
| Mihai Dumitru Gheorge | Bucharest | Romania |
| Aurel Nirestean M.D./Ph.D. | Târgu Mureş | Romania |
| Ivana Timotijevic M.D. | Belgrade | Serbia and Montenegro |
| Jelena Martinovic M.D. | Belgrade | Serbia and Montenegro |
| Vladimir Diligenski M.D. | Belgrade | Serbia and Montenegro |
| Vladimir Paunovic M.D. | Belgrade | Serbia and Montenegro |
| Dragana Ignjatovic-Ristic M.D. | Kragujevac | Serbia and Montenegro |
| Ratomir Lisulov M.D. | Novi Sad | Serbia and Montenegro |
| 11593077 | Background | 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. |
| 29523415 | Derived | 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. |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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