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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics
ClinicalTrials.gov Identifier:
NCT00208156
First received: September 13, 2005
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  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 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.


Condition Intervention Phase
Depressive Disorder, Major
 Drug: Mifepristone
 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study of the Safety and Tolerability of CORLUX™ (Mifepristone) for Recurrent Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Corcept Therapeutics:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of Corlux (mifepristone) for the treatment of recurrent psychotic symptoms with major depression with psychotic features (PMD) who previously participated in Corcept Therapeutics Protocol C-1073-07

Secondary Outcome Measures:
  • To assess the frequency of retreatment with Corlux in patients with PMD and qualitatively describe the psychotic symptoms for which retreatment is clinically indicated

Enrollment: 87
Study Start Date: May 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mifepristone Drug: Mifepristone

  Eligibility

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Have a major medical problem
  • 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: NCT00208156

Locations
United States, California
Cnri, Llc
San Diego, California, United States, 92126
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
United States, Nevada
Robert Horne M.D.
Las Vegas, Nevada, United States, 89102
United States, New Jersey
CNS Research Institute (CRI)
Clementon, New Jersey, United States, 08021
New Jersey Medical School - UMDNJ
Newark, New Jersey, United States, 07101
BioBehavioral Health
Toms River, New Jersey, United States, 08755
United States, New York
Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Neurobehavioral Research, Inc.
Lawrence, New York, United States, 11559
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73101
United States, Pennsylvania
CNS Research Institute (CRI)
Philadelphia, Pennsylvania, United States, 19149
United States, Texas
Claghorn-Lesem Research Clinic
Bellaire, Texas, United States, 77401
United States, Virginia
International Clinical Research Associates
Richmond, Virginia, United States, 23229
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
Corcept Therapeutics
Investigators
Study Director: Katherine Beebe, PhD Corcept Therapeutics
  More Information

Additional Information:
Corcept Therapeutics  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT00208156     History of Changes
Other Study ID Numbers: C-1073-10
Study First Received: September 13, 2005
Last Updated: February 14, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Mental Disorders
Psychotic Disorders
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Mifepristone
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
 Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on May 23, 2013