Clinical trial NCT00128479: A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Psychotic Disorders
Keywords: PMD
Psychotic Depression
Psychosis
Major Depression
Depression
Psychotic Major Depression
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-08-10
Enrollment: 443
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: screen, Days 0, 7, 14, 28, 42, 56
Secondary outcomes:
measure: The change in a measure of depression
timeFrame: screen, Days 0,7, 14, 28, 42, 56
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: K&S Research Services
state: Arkansas
city: Cerritos
country: United States
facility: Center for Emotional Fitness
state: California
city: Fountain Valley
country: United States
facility: Harbor Medical Associates, Inc.
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: Riverside
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Torrance
country: United States
facility: AV Institute, Inc.
state: California
city: Westminster
country: United States
facility: Neuropsychiatric Institute of Orange County
state: California
city: Hamden
country: United States
facility: Geriatric and Adult Psych
state: Connecticut
city: Washington
country: United States
facility: Comprehensive NeuroScience, Inc.
state: District of Columbia
city: Ft. Lauderdale
country: United States
facility: Professional Clinical Research Inc.
state: Florida
city: Jacksonville
country: United States
facility: Amit Vijapura, MD
state: Florida
city: Miami
country: United States
facility: Tukoi Inst for Clinical Research
state: Florida
city: North Miami
country: United States
facility: Bioquan Research Group, Inc.
state: Florida
city: North Miami
country: United States
facility: Scientific Clinical Research, Inc.
state: Florida
city: Sebring
country: United States
facility: Mark Ashby, MD
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials, LLC
state: Florida
city: Honolulu
country: United States
facility: Hawaii Clinical Research Center
state: Hawaii
city: Oakbrook Terrace
country: United States
facility: Midwest Center for Neurobehavioral Medicine
state: Illinois
city: Schaumburg
country: United States
facility: Peryam and Kroll Health Care Research
state: Illinois
city: Skokie
country: United States
facility: Clintell, Inc.
state: Illinois
city: Prairie Village
country: United States
facility: CTT Research
state: Kansas
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials
state: Louisiana
city: New Orleans
country: United States
facility: Louisiana Research Associates, Inc
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: St. Charles
country: United States
facility: Saaid Khojasteh & Assoc, Inc
state: Missouri
city: St. Louis
country: United States
facility: Medex Healthcare Research
state: Missouri
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience, Inc.
state: New Mexico
city: Bronx
country: United States
facility: Anxiety and Depression Clinic at Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: Brooklyn Medical Institute
state: New York
city: Elmsford
country: United States
facility: Advanced Bio-Behavioral Science, Inc
state: New York
city: Staten Island
country: United States
facility: Saint Vincent Catholic Medical Centers of New York
state: New York
city: Cleveland
country: United States
facility: Lutheran Hospital
state: Ohio
city: Middleburg Heights
country: United States
facility: Southwest Cleveland Sleep Center, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Moon Township
country: United States
facility: Crossroads Counseling & Consulting Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: CNS Research Institute (CRI)
state: Pennsylvania
city: Charleston
country: United States
facility: Segal Institute
state: South Carolina
city: Johnson City
country: United States
facility: Harmony Research
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Desoto
country: United States
facility: The Cedars Hospital, InSite Clinical Research
state: Texas
city: Houston
country: United States
facility: Felin-Jennings Clinic
state: Texas
city: Lake Jackson
country: United States
facility: R&D Clinical Research, Inc.
state: Texas
city: Seattle
country: United States
facility: America's Doctor/Essential Doctor, Inc
state: Washington
Study officials:
affiliation: Corcept Therapeutics
name: Katherine Beebe, PhD
role: STUDY_DIRECTOR
References:
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: 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: Kruizinga 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.
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.