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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00130676
First Posted: August 16, 2005
Last Update Posted: February 15, 2012
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.
Information provided by (Responsible Party):
Corcept Therapeutics
  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 Drug: matching placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Corcept Therapeutics:

Primary Outcome Measures:
  • The change in a measure of psychosis [ Time Frame: screening and on Days 0, 7, 14, 28, 42, and 56 ]

Secondary Outcome Measures:
  • The change in a measure of depression [ Time Frame: screening and on Days 0, 7, 14, 28, 42, and 56 ]

Enrollment: 257
Study Start Date: September 2004
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mifepristone 600 mg Drug: Mifepristone
daily for 7 days
Placebo Comparator: matching placebo Drug: matching placebo
daily for 7 days

  Eligibility

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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00130676


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

Additional Information:
Publications:
Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT00130676     History of Changes
Other Study ID Numbers: C-1073-07
First Submitted: August 12, 2005
First Posted: August 16, 2005
Last Update Posted: February 15, 2012
Last Verified: February 2012

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

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Mental Disorders
Psychotic Disorders
Pathologic Processes
Mood Disorders
Behavioral Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders
Mifepristone
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