A United States Study of Corlux for Psychotic Symptoms in Psychotic Major Depression
- Conditions
- Major Depressive DisorderPsychotic Disorders
- Interventions
- Drug: matching placebo
- Registration Number
- NCT00130676
- 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
- 257
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 matching placebo matching placebo - mifepristone 600 mg Mifepristone -
- Primary Outcome Measures
Name Time Method The change in a measure of psychosis screening and on Days 0, 7, 14, 28, 42, and 56
- Secondary Outcome Measures
Name Time Method The change in a measure of depression screening and on Days 0, 7, 14, 28, 42, and 56
Trial Locations
- Locations (22)
NMDNJ
🇺🇸Newark, New Jersey, United States
CNRI-LA
🇺🇸Pico Rivera, California, United States
Neurobehavioral Research Company
🇺🇸Lawrence, New York, United States
Robert Horne, MD
🇺🇸Las Vegas, Nevada, United States
University of Florida Clinical Trials
🇺🇸Jacksonville, Florida, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Claghorn-Lesem Research Clinic
🇺🇸Bellaire, Texas, United States
International Clinical Research Associates
🇺🇸Richmond, Virginia, United States
Grayline Clinical Drug Trials
🇺🇸Wichita Falls, Texas, United States
Psychopharmacology Research
🇺🇸Farmington Hills, Michigan, United States
Behavioral Health 2000, LLC
🇺🇸Riverside, California, United States
Cnri, Llc
🇺🇸San Diego, California, United States
CNS Research Institute
🇺🇸Philadelphia, Pennsylvania, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
American Medical Research, Inc.
🇺🇸Oak Brook, Illinois, United States
Quantum Laboratories/Memory Disorder Center
🇺🇸Pompano Beach, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Valle Vista Health System
🇺🇸Greenwood, Indiana, United States
Rakesh Ranjan, MD and Associates, Inc
🇺🇸Lyndhurst, Ohio, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Zucker Hillside Hospital
🇺🇸Glen Oaks, New York, United States