A United States Study of Corlux for Psychotic Symptoms in Psychotic Major Depression

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder, Psychotic Disorders

In brief

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).

Key facts

Study ID

NCT00130676

Run by

Corcept Therapeutics

People needed

257

Starts

2004-09-01

Expected to finish

2006-06-01

Last updated by the study team

2012-02-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• CNRI-LA — Pico Rivera, California, United States
• Behavioral Health 2000, LLC — Riverside, California, United States
• Cnri, Llc — San Diego, California, United States
• University of Florida Clinical Trials — Jacksonville, Florida, United States
• Quantum Laboratories/Memory Disorder Center — Pompano Beach, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• American Medical Research, Inc. — Oak Brook, Illinois, United States
• Valle Vista Health System — Greenwood, Indiana, United States
• Psychopharmacology Research — Farmington Hills, Michigan, United States
• Robert Horne, MD — Las Vegas, Nevada, United States
• CNS Research Institute — Clementon, New Jersey, United States
• NMDNJ — Newark, New Jersey, United States
• Bio Behavioral Health — Toms River, New Jersey, United States
• Zucker Hillside Hospital — Glen Oaks, New York, United States
• Neurobehavioral Research Company — Lawrence, New York, United States
• Midwest Clinical Research Center — Dayton, Ohio, United States
• Rakesh Ranjan, MD and Associates, Inc — Lyndhurst, Ohio, United States
• IPS Research Company — Oklahoma City, Oklahoma, United States
• CNS Research Institute — Philadelphia, Pennsylvania, United States
• Claghorn-Lesem Research Clinic — Bellaire, Texas, United States
• Grayline Clinical Drug Trials — Wichita Falls, Texas, United States
• International Clinical Research Associates — Richmond, Virginia, United States
• Northwest Clinical Research Center — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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