COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00128479
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : February 15, 2012
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Psychotic Disorders Drug: mifepristone Drug: mifepristone matched placebo Drug: mifepristone 600 mg Drug: mifepristone 1200 mg Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 443 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Efficacy of Three Dose Levels of CORLUX™ (Mifepristone) Plus an Antidepressant vs. Placebo Plus an Antidepressant in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features (PMD)
Study Start Date : September 2004
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: mifepristone 300 mg Drug: mifepristone
mifepristone 300 mg daily for 7 dats

Placebo Comparator: placebo Drug: mifepristone matched placebo
daily for 7 days

Experimental: mifepristone 600 mg Drug: mifepristone 600 mg
mifepristone 600 mg daily for 7 days

Experimental: mifepristone 1200 mg Drug: mifepristone 1200 mg
mifepristone 1200 mg daily for 7 days

Primary Outcome Measures :
  1. The change in a measure of psychosis [ Time Frame: screen, Days 0, 7, 14, 28, 42, 56 ]

Secondary Outcome Measures :
  1. The change in a measure of depression [ Time Frame: screen, Days 0,7, 14, 28, 42, 56 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00128479

Show Show 44 study locations
Sponsors and Collaborators
Corcept Therapeutics
Layout table for investigator information
Study Director: Katherine Beebe, PhD Corcept Therapeutics

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Corcept Therapeutics Identifier: NCT00128479    
Other Study ID Numbers: C-1073-06
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: February 15, 2012
Last Verified: February 2012
Keywords provided by Corcept Therapeutics:
Psychotic Depression
Major Depression
Psychotic Major Depression
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depressive Disorder, Major
Mental Disorders
Psychotic Disorders
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents