An International Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics
ClinicalTrials.gov Identifier:
NCT00146523
First received: September 2, 2005
Last updated: February 14, 2012
Last verified: February 2012

September 2, 2005
February 14, 2012
May 2005
July 2006   (final data collection date for primary outcome measure)
The change in a measure of psychosis [ Time Frame: screening and on Days 0, 7, 14, 28, 42, and 56 ] [ Designated as safety issue: Yes ]
The change in a measure of psychosis
Complete list of historical versions of study NCT00146523 on ClinicalTrials.gov Archive Site
The change in a measure of depression [ Time Frame: screening and on Days 0, 7, 14, 28, 42, and 56 ] [ Designated as safety issue: Yes ]
The change in a measure of depression
Not Provided
Not Provided
 
An International Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression
An International, Double-Blind, Placebo-Controlled, Study of the Efficacy and Safety of CORLUX™ (Mifepristone) vs. Placebo in the Treatment of Psychotic Symptoms in Patients With Psychotic Major Depression (PMD)

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Mifepristone
  • Drug: placebo
  • Experimental: mifepristone 600 mg
    Intervention: Drug: Mifepristone
  • Placebo Comparator: matching placebo
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
247
July 2006
July 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Are 18 to 75 years of age
  • Have a diagnosis of major depressive disorder with psychotic features (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM IV] 296.24 or 296.34)
  • Are able to provide written informed consent.

Exclusion Criteria:

  • 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).
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Croatia,   Former Serbia and Montenegro,   Romania
 
NCT00146523
C-1073-09
No
Corcept Therapeutics
Corcept Therapeutics
Not Provided
Study Director: Katherine Beebe, PhD Corcept Therapeutics
Corcept Therapeutics
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP