A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression
- Conditions
- Major Depressive DisorderPsychotic Disorders
- Interventions
- Registration Number
- NCT00128479
- Lead Sponsor
- Corcept Therapeutics
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 443
Individuals eligible for enrollment into this study are male and female adult patients who:
- Are 18 to 75 years of age
- Have a diagnosis of major depressive disorder with psychotic features (DSM-IV 296.24 or 296.34)
- Are able to provide written informed consent.
Individuals not eligible to be enrolled into the study are those who:
- Have a major medical problem
- Have previously participated in a CORLUX (C-1073, mifepristone) clinical trial
- Have a history of an allergic reaction to CORLUX (C-1073, mifepristone).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mifepristone 1200 mg mifepristone 1200 mg - placebo mifepristone matched placebo - mifepristone 600 mg mifepristone 600 mg - mifepristone 300 mg mifepristone -
- Primary Outcome Measures
Name Time Method The change in a measure of psychosis screen, Days 0, 7, 14, 28, 42, 56
- Secondary Outcome Measures
Name Time Method The change in a measure of depression screen, Days 0,7, 14, 28, 42, 56
Trial Locations
- Locations (44)
Saint Vincent Catholic Medical Centers of New York
🇺🇸Staten Island, New York, United States
CNS Research Institute (CRI)
🇺🇸Philadelphia, Pennsylvania, United States
Harmony Research
🇺🇸Johnson City, Tennessee, United States
K&S Research Services
🇺🇸Little Rock, Arkansas, United States
Crossroads Counseling & Consulting Associates
🇺🇸Moon Township, Pennsylvania, United States
Center for Emotional Fitness
🇺🇸Cerritos, California, United States
Geriatric and Adult Psych
🇺🇸Hamden, Connecticut, United States
Harbor Medical Associates, Inc.
🇺🇸Fountain Valley, California, United States
Synergy Clinical Research Center
🇺🇸National City, California, United States
Bioquan Research Group, Inc.
🇺🇸North Miami, Florida, United States
Peryam and Kroll Health Care Research
🇺🇸Schaumburg, Illinois, United States
Excell Research
🇺🇸Oceanside, California, United States
Amit Vijapura, MD
🇺🇸Jacksonville, Florida, United States
Mark Ashby, MD
🇺🇸Sebring, Florida, United States
AV Institute, Inc.
🇺🇸Torrance, California, United States
Clintell, Inc.
🇺🇸Skokie, Illinois, United States
Lutheran Hospital
🇺🇸Cleveland, Ohio, United States
Lake Charles Clinical Trials
🇺🇸Lake Charles, Louisiana, United States
Medex Healthcare Research
🇺🇸St. Louis, Missouri, United States
Saaid Khojasteh & Assoc, Inc
🇺🇸St. Charles, Missouri, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
America's Doctor/Essential Doctor, Inc
🇺🇸Seattle, Washington, United States
R&D Clinical Research, Inc.
🇺🇸Lake Jackson, Texas, United States
Advanced Bio-Behavioral Science, Inc
🇺🇸Elmsford, New York, United States
Brooklyn Medical Institute
🇺🇸Brooklyn, New York, United States
Felin-Jennings Clinic
🇺🇸Houston, Texas, United States
The Cedars Hospital, InSite Clinical Research
🇺🇸Desoto, Texas, United States
Tukoi Inst for Clinical Research
🇺🇸Miami, Florida, United States
Scientific Clinical Research, Inc.
🇺🇸North Miami, Florida, United States
Pacific Clinical Research Medical Group
🇺🇸Riverside, California, United States
LSU Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Comprehensive NeuroScience, Inc.
🇺🇸Washington, District of Columbia, United States
Professional Clinical Research Inc.
🇺🇸Ft. Lauderdale, Florida, United States
Albuquerque Neuroscience, Inc.
🇺🇸Albuquerque, New Mexico, United States
Neuropsychiatric Institute of Orange County
🇺🇸Westminster, California, United States
Southwest Cleveland Sleep Center, Inc.
🇺🇸Middleburg Heights, Ohio, United States
Stedman Clinical Trials, LLC
🇺🇸Tampa, Florida, United States
Hawaii Clinical Research Center
🇺🇸Honolulu, Hawaii, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Segal Institute
🇺🇸Charleston, South Carolina, United States
Louisiana Research Associates, Inc
🇺🇸New Orleans, Louisiana, United States
Anxiety and Depression Clinic at Montefiore Medical Center
🇺🇸Bronx, New York, United States
Midwest Center for Neurobehavioral Medicine
🇺🇸Oakbrook Terrace, Illinois, United States
CTT Research
🇺🇸Prairie Village, Kansas, United States