A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Efficacy of Three Dose Levels of CORLUX™ (Mifepristone) Plus an Antidepressant vs. Placebo Plus an Antidepressant in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features (PMD)
1 other identifier
interventional
443
1 country
44
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 P50-P75 for phase_3 major-depressive-disorder
Started Sep 2004
Typical duration for phase_3 major-depressive-disorder
44 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 8, 2005
CompletedFirst Posted
Study publicly available on registry
August 10, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedFebruary 15, 2012
February 1, 2012
2.3 years
August 8, 2005
February 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change in a measure of psychosis
screen, Days 0, 7, 14, 28, 42, 56
Secondary Outcomes (1)
The change in a measure of depression
screen, Days 0,7, 14, 28, 42, 56
Study Arms (4)
mifepristone 300 mg
EXPERIMENTALplacebo
PLACEBO COMPARATORmifepristone 600 mg
EXPERIMENTALmifepristone 1200 mg
EXPERIMENTALInterventions
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 (44)
K&S Research Services
Little Rock, Arkansas, 72201, United States
Center for Emotional Fitness
Cerritos, California, 90703, United States
Harbor Medical Associates, Inc.
Fountain Valley, California, 92708, United States
Synergy Clinical Research Center
National City, California, 91950, United States
Excell Research
Oceanside, California, 92056, United States
Pacific Clinical Research Medical Group
Riverside, California, 92506, United States
AV Institute, Inc.
Torrance, California, 90505, United States
Neuropsychiatric Institute of Orange County
Westminster, California, 92683, United States
Geriatric and Adult Psych
Hamden, Connecticut, 06518, United States
Comprehensive NeuroScience, Inc.
Washington D.C., District of Columbia, 20016, United States
Professional Clinical Research Inc.
Fort Lauderdale, Florida, 33319, United States
Amit Vijapura, MD
Jacksonville, Florida, 32256, United States
Tukoi Inst for Clinical Research
Miami, Florida, 33180, United States
Bioquan Research Group, Inc.
North Miami, Florida, 33161, United States
Scientific Clinical Research, Inc.
North Miami, Florida, 33161, United States
Mark Ashby, MD
Sebring, Florida, 33870, United States
Stedman Clinical Trials, LLC
Tampa, Florida, 33613, United States
Hawaii Clinical Research Center
Honolulu, Hawaii, 96826, United States
Midwest Center for Neurobehavioral Medicine
Oakbrook Terrace, Illinois, 60181, United States
Peryam and Kroll Health Care Research
Schaumburg, Illinois, 60194, United States
Clintell, Inc.
Skokie, Illinois, 60077, United States
CTT Research
Prairie Village, Kansas, 66206, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70601, United States
Louisiana Research Associates, Inc
New Orleans, Louisiana, 70114, United States
LSU Health Sciences Center
Shreveport, Louisiana, 71103, United States
Saaid Khojasteh & Assoc, Inc
Saint Charles, Missouri, 63301, United States
Medex Healthcare Research
St Louis, Missouri, 63108, United States
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87102, United States
Brooklyn Medical Institute
Brooklyn, New York, 11223, United States
Advanced Bio-Behavioral Science, Inc
Elmsford, New York, 10523, United States
Saint Vincent Catholic Medical Centers of New York
Staten Island, New York, 10304, United States
Anxiety and Depression Clinic at Montefiore Medical Center
The Bronx, New York, 10467, United States
Lutheran Hospital
Cleveland, Ohio, 44109, United States
Southwest Cleveland Sleep Center, Inc.
Middleburg Heights, Ohio, 44130, United States
IPS Research Company
Oklahoma City, Oklahoma, 73101, United States
Crossroads Counseling & Consulting Associates
Moon Township, Pennsylvania, 15108, United States
CNS Research Institute (CRI)
Philadelphia, Pennsylvania, 19149, United States
Segal Institute
Charleston, South Carolina, 29405, United States
Harmony Research
Johnson City, Tennessee, 37601, United States
UT Southwestern Medical Center
Dallas, Texas, 75235, United States
The Cedars Hospital, InSite Clinical Research
DeSoto, Texas, 75115, United States
Felin-Jennings Clinic
Houston, Texas, 77074, United States
R&D Clinical Research, Inc.
Lake Jackson, Texas, 77566, United States
America's Doctor/Essential Doctor, Inc
Seattle, Washington, 98126, United States
Related Publications (5)
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. doi: 10.2165/00003495-199345030-00007.
PMID: 7682909BACKGROUNDBelanoff 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: 11593077BACKGROUNDKruizinga J, Liemburg E, Burger H, Cipriani A, Geddes J, Robertson L, Vogelaar B, Nolen WA. Pharmacological treatment for psychotic depression. Cochrane Database Syst Rev. 2021 Dec 7;12(12):CD004044. doi: 10.1002/14651858.CD004044.pub5.
PMID: 34875106DERIVEDBlock 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 8, 2005
First Posted
August 10, 2005
Study Start
September 1, 2004
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
February 15, 2012
Record last verified: 2012-02