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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130676
• Other study ID #: C-1073-07
• Status: Completed
• Phase: Phase 3
• First received: August 12, 2005
• Last updated: February 14, 2012
• Start date: September 2004
• Est. completion date: June 2006

Study information

• Verified date: February 2012
• Source: Corcept Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• Mifepristone
daily for 7 days
• matching placebo
daily for 7 days

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Claghorn-Lesem Research Clinic	Bellaire	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	CNS Research Institute	Clementon	New Jersey
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Psychopharmacology Research	Farmington Hills	Michigan
United States	Zucker Hillside Hospital	Glen Oaks	New York
United States	Valle Vista Health System	Greenwood	Indiana
United States	University of Florida Clinical Trials	Jacksonville	Florida
United States	Robert Horne, MD	Las Vegas	Nevada
United States	Neurobehavioral Research Company	Lawrence	New York
United States	Rakesh Ranjan, MD and Associates, Inc	Lyndhurst	Ohio
United States	NMDNJ	Newark	New Jersey
United States	American Medical Research, Inc.	Oak Brook	Illinois
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	CNS Research Institute	Philadelphia	Pennsylvania
United States	CNRI-LA	Pico Rivera	California
United States	Quantum Laboratories/Memory Disorder Center	Pompano Beach	Florida
United States	International Clinical Research Associates	Richmond	Virginia
United States	Behavioral Health 2000, LLC	Riverside	California
United States	Cnri, Llc	San Diego	California
United States	Bio Behavioral Health	Toms River	New Jersey
United States	Grayline Clinical Drug Trials	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in a measure of psychosis		screening and on Days 0, 7, 14, 28, 42, and 56	Yes
Secondary	The change in a measure of depression		screening and on Days 0, 7, 14, 28, 42, and 56	Yes

External Links

•   Corcept Therapeutics