A United States Study of the Safety and Tolerability 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

NCT00128479

Run by

Corcept Therapeutics

People needed

443

Starts

2004-09-01

Expected to finish

2007-01-01

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

• K&S Research Services — Little Rock, Arkansas, United States
• Center for Emotional Fitness — Cerritos, California, United States
• Harbor Medical Associates, Inc. — Fountain Valley, California, United States
• Synergy Clinical Research Center — National City, California, United States
• Excell Research — Oceanside, California, United States
• Pacific Clinical Research Medical Group — Riverside, California, United States
• AV Institute, Inc. — Torrance, California, United States
• Neuropsychiatric Institute of Orange County — Westminster, California, United States
• Geriatric and Adult Psych — Hamden, Connecticut, United States
• Comprehensive NeuroScience, Inc. — Washington D.C., District of Columbia, United States
• Professional Clinical Research Inc. — Fort Lauderdale, Florida, United States
• Amit Vijapura, MD — Jacksonville, Florida, United States
• Tukoi Inst for Clinical Research — Miami, Florida, United States
• Bioquan Research Group, Inc. — North Miami, Florida, United States
• Scientific Clinical Research, Inc. — North Miami, Florida, United States
• Mark Ashby, MD — Sebring, Florida, United States
• Stedman Clinical Trials, LLC — Tampa, Florida, United States
• Hawaii Clinical Research Center — Honolulu, Hawaii, United States
• Midwest Center for Neurobehavioral Medicine — Oakbrook Terrace, Illinois, United States
• Peryam and Kroll Health Care Research — Schaumburg, Illinois, United States
• Clintell, Inc. — Skokie, Illinois, United States
• CTT Research — Prairie Village, Kansas, United States
• Lake Charles Clinical Trials — Lake Charles, Louisiana, United States
• Louisiana Research Associates, Inc — New Orleans, Louisiana, United States
• LSU Health Sciences Center — Shreveport, Louisiana, United States

Full record on ClinicalTrials.gov

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