A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression
Public ClinicalTrials.gov record NCT00128479. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Efficacy of Three Dose Levels of CORLUX™ (Mifepristone) Plus an Antidepressant vs. Placebo Plus an Antidepressant in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features (PMD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT00128479
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 443 participants
Conditions and interventions
Conditions
Interventions
- mifepristone Drug
- mifepristone matched placebo Drug
- mifepristone 600 mg Drug
- mifepristone 1200 mg Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2004 (Type not available)
- Primary completion
- Jan 2007 (Actual)
- Completion
- Jan 2007 (Actual)
- Last update posted
- Feb 15, 2012
2004 – 2007
United States locations
- U.S. sites
- 44
- U.S. states
- 19
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| K&S Research Services | Little Rock | Arkansas | 72201 | — |
| Center for Emotional Fitness | Cerritos | California | 90703 | — |
| Harbor Medical Associates, Inc. | Fountain Valley | California | 92708 | — |
| Synergy Clinical Research Center | National City | California | 91950 | — |
| Excell Research | Oceanside | California | 92056 | — |
| Pacific Clinical Research Medical Group | Riverside | California | 92506 | — |
| AV Institute, Inc. | Torrance | California | 90505 | — |
| Neuropsychiatric Institute of Orange County | Westminster | California | 92683 | — |
| Geriatric and Adult Psych | Hamden | Connecticut | 06518 | — |
| Comprehensive NeuroScience, Inc. | Washington D.C. | District of Columbia | 20016 | — |
| Professional Clinical Research Inc. | Fort Lauderdale | Florida | 33319 | — |
| Amit Vijapura, MD | Jacksonville | Florida | 32256 | — |
| Tukoi Inst for Clinical Research | Miami | Florida | 33180 | — |
| Bioquan Research Group, Inc. | North Miami | Florida | 33161 | — |
| Scientific Clinical Research, Inc. | North Miami | Florida | 33161 | — |
| Mark Ashby, MD | Sebring | Florida | 33870 | — |
| Stedman Clinical Trials, LLC | Tampa | Florida | 33613 | — |
| Hawaii Clinical Research Center | Honolulu | Hawaii | 96826 | — |
| Midwest Center for Neurobehavioral Medicine | Oakbrook Terrace | Illinois | 60181 | — |
| Peryam and Kroll Health Care Research | Schaumburg | Illinois | 60194 | — |
| Clintell, Inc. | Skokie | Illinois | 60077 | — |
| CTT Research | Prairie Village | Kansas | 66206 | — |
| Lake Charles Clinical Trials | Lake Charles | Louisiana | 70601 | — |
| Louisiana Research Associates, Inc | New Orleans | Louisiana | 70114 | — |
| LSU Health Sciences Center | Shreveport | Louisiana | 71103 | — |
| Saaid Khojasteh & Assoc, Inc | Saint Charles | Missouri | 63301 | — |
| Medex Healthcare Research | St Louis | Missouri | 63108 | — |
| Albuquerque Neuroscience, Inc. | Albuquerque | New Mexico | 87102 | — |
| Brooklyn Medical Institute | Brooklyn | New York | 11223 | — |
| Advanced Bio-Behavioral Science, Inc | Elmsford | New York | 10523 | — |
| Saint Vincent Catholic Medical Centers of New York | Staten Island | New York | 10304 | — |
| Anxiety and Depression Clinic at Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Lutheran Hospital | Cleveland | Ohio | 44109 | — |
| Southwest Cleveland Sleep Center, Inc. | Middleburg Heights | Ohio | 44130 | — |
| IPS Research Company | Oklahoma City | Oklahoma | 73101 | — |
| Crossroads Counseling & Consulting Associates | Moon Township | Pennsylvania | 15108 | — |
| CNS Research Institute (CRI) | Philadelphia | Pennsylvania | 19149 | — |
| Segal Institute | Charleston | South Carolina | 29405 | — |
| Harmony Research | Johnson City | Tennessee | 37601 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75235 | — |
| The Cedars Hospital, InSite Clinical Research | DeSoto | Texas | 75115 | — |
| Felin-Jennings Clinic | Houston | Texas | 77074 | — |
| R&D Clinical Research, Inc. | Lake Jackson | Texas | 77566 | — |
| America's Doctor/Essential Doctor, Inc | Seattle | Washington | 98126 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00128479, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 15, 2012 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00128479 live on ClinicalTrials.gov.