A United States Study of Corlux for Psychotic Symptoms in Psychotic Major Depression - Full Text View

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Depression Psychotic Disorders

Drug Information available for: Mifepristone

U.S. FDA Resources

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

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Locations

United States, California
CNRI, LLC
San Diego, California, United States, 92126
CNRI-LA
Pico Rivera, California, United States, 90660
Behavioral Health 2000, LLC
Riverside, California, United States, 92506
United States, Florida
Quantum Laboratories/Memory Disorder Center
Pompano Beach, Florida, United States, 33064
University of Florida Clinical Trials
Jacksonville, Florida, United States, 32257
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
United States, Illinois
American Medical Research, Inc.
Oak Brook, Illinois, United States, 60523
United States, Indiana
Valle Vista Health System
Greenwood, Indiana, United States, 46143
United States, Michigan
Psychopharmacology Research
Farmington Hills, Michigan, United States, 48334
United States, Nevada
Robert Horne, MD
Las Vegas, Nevada, United States, 89102
United States, New Jersey
CNS Research Institute
Clementon, New Jersey, United States, 08021
Bio Behavioral Health
Toms River, New Jersey, United States, 08755
NMDNJ
Newark, New Jersey, United States, 07101
United States, New York
Neurobehavioral Research Company
Lawrence, New York, United States, 11559
Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
United States, Ohio
Midwest Clinical Research Center
Dayton, Ohio, United States, 45408
Rakesh Ranjan, MD and Associates, Inc
Lyndhurst, Ohio, United States, 44124
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73101
United States, Pennsylvania
CNS Research Institute
Philadelphia, Pennsylvania, United States, 19149
United States, Texas
Claghorn-Lesem Research Clinic
Bellaire, Texas, United States, 77401
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States, 76309
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:

Belanoff JK, Rothschild AJ, Cassidy F, DeBattista C, Baulieu EE, Schold C, Schatzberg AF. An open label trial of C-1073 (mifepristone) for psychotic major depression. Biol Psychiatry. 2002 Sep 1;52(5):386-92.

Belanoff JK, Flores BH, Kalezhan M, Sund B, Schatzberg AF. Rapid reversal of psychotic depression using mifepristone. J Clin Psychopharmacol. 2001 Oct;21(5):516-21.

Brogden RN, Goa KL, Faulds D. Mifepristone. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential. Drugs. 1993 Mar;45(3):384-409. Review. Erratum in: Drugs 1993 Aug;46(2):268.

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

Keywords provided by Corcept Therapeutics:

PMD
Psychotic Major Depression
Depression

Major Depression
Psychosis
Psychotic Major Depression

Additional relevant MeSH terms:

Contraceptives, Postcoital, Synthetic
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Depressive Disorder, Major
Reproductive Control Agents
Pathologic Processes
Mental Disorders
Therapeutic Uses
Abortifacient Agents
Menstruation-Inducing Agents

Contraceptives, Oral, Synthetic
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Abortifacient Agents, Steroidal
Disease
Depression
Mifepristone
Depressive Disorder
Contraceptives, Postcoital
Luteolytic Agents
Pharmacologic Actions
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on November 27, 2009