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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 | daily for 7 days |
| |
| matching 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:
Individuals eligible for enrollment into this study are male and female adult patients who:
Exclusion Criteria:
Individuals not eligible to be enrolled into the study are those who:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Beebe, PhD | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CNRI-LA | Pico Rivera | California | 90660 | United States | ||
| Behavioral Health 2000, LLC |
| 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. | |
| 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. |
| Label | URL |
|---|---|
| Corcept Therapeutics | View source |
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| Drug |
daily for 7 days |
|
| Riverside |
| California |
| 92506 |
| United States |
| Cnri, Llc | San Diego | California | 92126 | United States |
| University of Florida Clinical Trials | Jacksonville | Florida | 32257 | United States |
| Quantum Laboratories/Memory Disorder Center | Pompano Beach | Florida | 33064 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | United States |
| American Medical Research, Inc. | Oak Brook | Illinois | 60523 | United States |
| Valle Vista Health System | Greenwood | Indiana | 46143 | United States |
| Psychopharmacology Research | Farmington Hills | Michigan | 48334 | United States |
| Robert Horne, MD | Las Vegas | Nevada | 89102 | United States |
| CNS Research Institute | Clementon | New Jersey | 08021 | United States |
| NMDNJ | Newark | New Jersey | 07101 | United States |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | United States |
| Zucker Hillside Hospital | Glen Oaks | New York | 11004 | United States |
| Neurobehavioral Research Company | Lawrence | New York | 11559 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45408 | United States |
| Rakesh Ranjan, MD and Associates, Inc | Lyndhurst | Ohio | 44124 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73101 | United States |
| CNS Research Institute | Philadelphia | Pennsylvania | 19149 | United States |
| Claghorn-Lesem Research Clinic | Bellaire | Texas | 77401 | United States |
| Grayline Clinical Drug Trials | Wichita Falls | Texas | 76309 | United States |
| International Clinical Research Associates | Richmond | Virginia | 23229 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98004 | United States |
| 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. |
| 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 |
| D011618 | Psychotic Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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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