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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 300 mg | Experimental |
| |
| placebo | Placebo Comparator |
| |
| mifepristone 600 mg | Experimental |
| |
| mifepristone 1200 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mifepristone | Drug | mifepristone 300 mg daily for 7 dats |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The change in a measure of psychosis | screen, Days 0, 7, 14, 28, 42, 56 |
| Measure | Description | Time Frame |
|---|---|---|
| The change in a measure of depression | screen, Days 0,7, 14, 28, 42, 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 |
|---|---|---|---|---|---|---|
| K&S Research Services | Little Rock | Arkansas | 72201 | United States | ||
| Center for Emotional Fitness |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 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. |
| Label | URL |
|---|---|
| Corcept Therapeutics | View source |
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| mifepristone matched placebo |
| Drug |
daily for 7 days |
|
| mifepristone 600 mg | Drug | mifepristone 600 mg daily for 7 days |
|
| mifepristone 1200 mg | Drug | mifepristone 1200 mg daily for 7 days |
|
| Cerritos |
| California |
| 90703 |
| United States |
| Harbor Medical Associates, Inc. | Fountain Valley | California | 92708 | United States |
| Synergy Clinical Research Center | National City | California | 91950 | United States |
| Excell Research | Oceanside | California | 92056 | United States |
| Pacific Clinical Research Medical Group | Riverside | California | 92506 | United States |
| AV Institute, Inc. | Torrance | California | 90505 | United States |
| Neuropsychiatric Institute of Orange County | Westminster | California | 92683 | United States |
| Geriatric and Adult Psych | Hamden | Connecticut | 06518 | United States |
| Comprehensive NeuroScience, Inc. | Washington D.C. | District of Columbia | 20016 | United States |
| Professional Clinical Research Inc. | Fort Lauderdale | Florida | 33319 | United States |
| Amit Vijapura, MD | Jacksonville | Florida | 32256 | United States |
| Tukoi Inst for Clinical Research | Miami | Florida | 33180 | United States |
| Bioquan Research Group, Inc. | North Miami | Florida | 33161 | United States |
| Scientific Clinical Research, Inc. | North Miami | Florida | 33161 | United States |
| Mark Ashby, MD | Sebring | Florida | 33870 | United States |
| Stedman Clinical Trials, LLC | Tampa | Florida | 33613 | United States |
| Hawaii Clinical Research Center | Honolulu | Hawaii | 96826 | United States |
| Midwest Center for Neurobehavioral Medicine | Oakbrook Terrace | Illinois | 60181 | United States |
| Peryam and Kroll Health Care Research | Schaumburg | Illinois | 60194 | United States |
| Clintell, Inc. | Skokie | Illinois | 60077 | United States |
| CTT Research | Prairie Village | Kansas | 66206 | United States |
| Lake Charles Clinical Trials | Lake Charles | Louisiana | 70601 | United States |
| Louisiana Research Associates, Inc | New Orleans | Louisiana | 70114 | United States |
| LSU Health Sciences Center | Shreveport | Louisiana | 71103 | United States |
| Saaid Khojasteh & Assoc, Inc | Saint Charles | Missouri | 63301 | United States |
| Medex Healthcare Research | St Louis | Missouri | 63108 | United States |
| Albuquerque Neuroscience, Inc. | Albuquerque | New Mexico | 87102 | United States |
| Brooklyn Medical Institute | Brooklyn | New York | 11223 | United States |
| Advanced Bio-Behavioral Science, Inc | Elmsford | New York | 10523 | United States |
| Saint Vincent Catholic Medical Centers of New York | Staten Island | New York | 10304 | United States |
| Anxiety and Depression Clinic at Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Lutheran Hospital | Cleveland | Ohio | 44109 | United States |
| Southwest Cleveland Sleep Center, Inc. | Middleburg Heights | Ohio | 44130 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73101 | United States |
| Crossroads Counseling & Consulting Associates | Moon Township | Pennsylvania | 15108 | United States |
| CNS Research Institute (CRI) | Philadelphia | Pennsylvania | 19149 | United States |
| Segal Institute | Charleston | South Carolina | 29405 | United States |
| Harmony Research | Johnson City | Tennessee | 37601 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75235 | United States |
| The Cedars Hospital, InSite Clinical Research | DeSoto | Texas | 75115 | United States |
| Felin-Jennings Clinic | Houston | Texas | 77074 | United States |
| R&D Clinical Research, Inc. | Lake Jackson | Texas | 77566 | United States |
| America's Doctor/Essential Doctor, Inc | Seattle | Washington | 98126 | United States |
| 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. |
| 34875106 | Derived | Kruizinga J, Liemburg E, Burger H, Cipriani A, Geddes J, Robertson L, Vogelaar B, Nolen WA. Pharmacological treatment for psychotic depression. Cochrane Database Syst Rev. 2021 Dec 7;12(12):CD004044. doi: 10.1002/14651858.CD004044.pub5. |
| 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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