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

Completed · Phase 3

Conditions studied: Depressive Disorder, Major

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 study is to allow patients who have already participated in an earlier 8 week study of Corlux versus placebo (an inactive pill) to receive additional courses of treatment with Corlux periodically if a psychotic episode should reappear during a period of one year.

Key facts

Study ID

NCT00208156

Run by

Corcept Therapeutics

People needed

87

Starts

2005-05-01

Expected to finish

2006-11-01

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…

• Completed participation through Day 56 in Corcept Therapeutics Protocol C-1073-07
• 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…

• Have a major medical problem
• Have a history of an allergic reaction to Corlux (C-1073, mifepristone)

Where it is running

• Cnri, Llc — San Diego, California, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Robert Horne M.D. — Las Vegas, Nevada, United States
• CNS Research Institute (CRI) — Clementon, New Jersey, United States
• New Jersey Medical School - UMDNJ — Newark, New Jersey, United States
• BioBehavioral Health — Toms River, New Jersey, United States
• Zucker Hillside Hospital — Glen Oaks, New York, United States
• Neurobehavioral Research, Inc. — Lawrence, New York, United States
• IPS Research Company — Oklahoma City, Oklahoma, United States
• CNS Research Institute (CRI) — Philadelphia, Pennsylvania, United States
• Claghorn-Lesem Research Clinic — Bellaire, 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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