A United States Study of Corlux for Psychotic Symptoms in Psychotic Major Depression
NCT ID: NCT00130676
Last Updated: 2012-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
257 participants
INTERVENTIONAL
2004-09-30
2006-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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mifepristone 600 mg
Mifepristone
daily for 7 days
matching placebo
matching placebo
daily for 7 days
Interventions
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Mifepristone
daily for 7 days
matching placebo
daily for 7 days
Eligibility Criteria
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Inclusion Criteria
* 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 previously participated in a Corlux (C-1073, mifepristone) clinical trial
* Have a history of an allergic reaction to Corlux (C-1073, mifepristone)
18 Years
75 Years
ALL
No
Sponsors
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Corcept Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Katherine Beebe, PhD
Role: STUDY_DIRECTOR
Corcept Therapeutics
Locations
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CNRI-LA
Pico Rivera, California, United States
Behavioral Health 2000, LLC
Riverside, California, United States
Cnri, Llc
San Diego, California, United States
University of Florida Clinical Trials
Jacksonville, Florida, United States
Quantum Laboratories/Memory Disorder Center
Pompano Beach, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
American Medical Research, Inc.
Oak Brook, Illinois, United States
Valle Vista Health System
Greenwood, Indiana, United States
Psychopharmacology Research
Farmington Hills, Michigan, United States
Robert Horne, MD
Las Vegas, Nevada, United States
CNS Research Institute
Clementon, New Jersey, United States
NMDNJ
Newark, New Jersey, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Zucker Hillside Hospital
Glen Oaks, New York, United States
Neurobehavioral Research Company
Lawrence, New York, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Rakesh Ranjan, MD and Associates, Inc
Lyndhurst, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
CNS Research Institute
Philadelphia, Pennsylvania, United States
Claghorn-Lesem Research Clinic
Bellaire, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
International Clinical Research Associates
Richmond, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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References
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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.
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. doi: 10.1097/00004714-200110000-00009.
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.
Block 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.
Related Links
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Corcept Therapeutics
Other Identifiers
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C-1073-07
Identifier Type: -
Identifier Source: org_study_id
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