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A United States Study of Corlux for Psychotic Symptoms in Psychotic Major Depression
This study has been completed.
Sponsored by: Corcept Therapeutics
Information provided by: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT00130676
  Purpose

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 Intervention Phase
Major Depressive Disorder
Psychotic Disorders
Drug: Mifepristone
Phase III

MedlinePlus related topics: Depression Psychotic Disorders
Drug Information available for: Mifepristone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of CORLUX™ (Mifepristone) in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features

Further study details as provided by Corcept Therapeutics:

Primary Outcome Measures:
  • The change in a measure of psychosis

Secondary Outcome Measures:
  • The change in a measure of depression

Estimated Enrollment: 280
Study Start Date: August 2004
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130676

  Show 23 Study Locations
Sponsors and Collaborators
Corcept Therapeutics
Investigators
Study Director: Katherine Beebe, PhD Corcept Therapeutics
  More Information

Corcept Therapeutics  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: C-1073-07
Study First Received: August 12, 2005
Last Updated: September 18, 2006
ClinicalTrials.gov Identifier: NCT00130676  
Health Authority: United States: Food and Drug Administration

Keywords provided by Corcept Therapeutics:
PMD
Psychotic Major Depression
Depression
Major Depression
Psychosis
Psychotic Major Depression

Study placed in the following topic categories:
Schizophrenia
Depression
Mental Disorders
Mood Disorders
Mifepristone
Psychotic Disorders
Depressive Disorder, Major
Depressive Disorder
Schizophrenia and Disorders with Psychotic Features
Behavioral Symptoms

Additional relevant MeSH terms:
Abortifacient Agents, Steroidal
Contraceptives, Postcoital, Synthetic
Disease
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Reproductive Control Agents
Luteolytic Agents
Contraceptives, Postcoital
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Abortifacient Agents
Menstruation-Inducing Agents
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on January 16, 2009