Clinical trial NCT00130676: A United States Study of Corlux for Psychotic Symptoms in Psychotic Major Depression
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Psychotic Disorders
Keywords: PMD
Psychotic Major Depression
Depression
Major Depression
Psychosis
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-08-16
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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)

Primary outcomes:
measure: The change in a measure of psychosis
timeFrame: screening and on Days 0, 7, 14, 28, 42, and 56
Secondary outcomes:
measure: The change in a measure of depression
timeFrame: screening and on Days 0, 7, 14, 28, 42, and 56
Other outcomes:
Locations:
city: Pico Rivera
country: United States
facility: CNRI-LA
state: California
city: Riverside
country: United States
facility: Behavioral Health 2000, LLC
state: California
city: San Diego
country: United States
facility: Cnri, Llc
state: California
city: Jacksonville
country: United States
facility: University of Florida Clinical Trials
state: Florida
city: Pompano Beach
country: United States
facility: Quantum Laboratories/Memory Disorder Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Oak Brook
country: United States
facility: American Medical Research, Inc.
state: Illinois
city: Greenwood
country: United States
facility: Valle Vista Health System
state: Indiana
city: Farmington Hills
country: United States
facility: Psychopharmacology Research
state: Michigan
city: Las Vegas
country: United States
facility: Robert Horne, MD
state: Nevada
city: Clementon
country: United States
facility: CNS Research Institute
state: New Jersey
city: Newark
country: United States
facility: NMDNJ
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Glen Oaks
country: United States
facility: Zucker Hillside Hospital
state: New York
city: Lawrence
country: United States
facility: Neurobehavioral Research Company
state: New York
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Lyndhurst
country: United States
facility: Rakesh Ranjan, MD and Associates, Inc
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Philadelphia
country: United States
facility: CNS Research Institute
state: Pennsylvania
city: Bellaire
country: United States
facility: Claghorn-Lesem Research Clinic
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Richmond
country: United States
facility: International Clinical Research Associates
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Corcept Therapeutics
name: Katherine Beebe, PhD
role: STUDY_DIRECTOR
References:
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. doi: 10.1016/s0006-3223(02)01432-4.
citation: 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.
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. doi: 10.2165/00003495-199345030-00007.
citation: 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.