A United States Study of Corlux for Psychotic Symptoms in Psychotic Major Depression
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
1 other identifier
interventional
257
1 country
23
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 major-depressive-disorder
Started Sep 2004
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 12, 2005
CompletedFirst Posted
Study publicly available on registry
August 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedFebruary 15, 2012
February 1, 2012
1.7 years
August 12, 2005
February 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change in a measure of psychosis
screening and on Days 0, 7, 14, 28, 42, and 56
Secondary Outcomes (1)
The change in a measure of depression
screening and on Days 0, 7, 14, 28, 42, and 56
Study Arms (2)
mifepristone 600 mg
EXPERIMENTALmatching placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
CNRI-LA
Pico Rivera, California, 90660, United States
Behavioral Health 2000, LLC
Riverside, California, 92506, United States
Cnri, Llc
San Diego, California, 92126, United States
University of Florida Clinical Trials
Jacksonville, Florida, 32257, United States
Quantum Laboratories/Memory Disorder Center
Pompano Beach, Florida, 33064, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
American Medical Research, Inc.
Oak Brook, Illinois, 60523, United States
Valle Vista Health System
Greenwood, Indiana, 46143, United States
Psychopharmacology Research
Farmington Hills, Michigan, 48334, United States
Robert Horne, MD
Las Vegas, Nevada, 89102, United States
CNS Research Institute
Clementon, New Jersey, 08021, United States
NMDNJ
Newark, New Jersey, 07101, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Zucker Hillside Hospital
Glen Oaks, New York, 11004, United States
Neurobehavioral Research Company
Lawrence, New York, 11559, United States
Midwest Clinical Research Center
Dayton, Ohio, 45408, United States
Rakesh Ranjan, MD and Associates, Inc
Lyndhurst, Ohio, 44124, United States
IPS Research Company
Oklahoma City, Oklahoma, 73101, United States
CNS Research Institute
Philadelphia, Pennsylvania, 19149, United States
Claghorn-Lesem Research Clinic
Bellaire, Texas, 77401, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
International Clinical Research Associates
Richmond, Virginia, 23229, United States
Northwest Clinical Research Center
Bellevue, Washington, 98004, United States
Related Publications (4)
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. doi: 10.1016/s0006-3223(02)01432-4.
PMID: 12242054BACKGROUNDBelanoff 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. doi: 10.1097/00004714-200110000-00009.
PMID: 11593077BACKGROUNDBrogden RN, Goa KL, Faulds D. Mifepristone. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential. Drugs. 1993 Mar;45(3):384-409. doi: 10.2165/00003495-199345030-00007.
PMID: 7682909BACKGROUNDBlock TS, Kushner H, Kalin N, Nelson C, Belanoff J, Schatzberg A. Combined Analysis of Mifepristone for Psychotic Depression: Plasma Levels Associated With Clinical Response. Biol Psychiatry. 2018 Jul 1;84(1):46-54. doi: 10.1016/j.biopsych.2018.01.008. Epub 2018 Jan 31.
PMID: 29523415DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Katherine Beebe, PhD
Corcept Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2005
First Posted
August 16, 2005
Study Start
September 1, 2004
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
February 15, 2012
Record last verified: 2012-02