A United States Study of Corlux for Psychotic Symptoms in Psychotic Major Depression

NCT ID: NCT00130676

Last Updated: 2012-02-15

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Major Depressive Disorder Psychotic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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mifepristone 600 mg

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

daily for 7 days

matching placebo

Group Type PLACEBO_COMPARATOR

matching placebo

Intervention Type DRUG

daily for 7 days

Interventions

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Mifepristone

daily for 7 days

Intervention Type DRUG

matching placebo

daily for 7 days

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corcept Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Behavioral Health 2000, LLC

Riverside, California, United States

Site Status

Cnri, Llc

San Diego, California, United States

Site Status

University of Florida Clinical Trials

Jacksonville, Florida, United States

Site Status

Quantum Laboratories/Memory Disorder Center

Pompano Beach, Florida, United States

Site Status

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Site Status

American Medical Research, Inc.

Oak Brook, Illinois, United States

Site Status

Valle Vista Health System

Greenwood, Indiana, United States

Site Status

Psychopharmacology Research

Farmington Hills, Michigan, United States

Site Status

Robert Horne, MD

Las Vegas, Nevada, United States

Site Status

CNS Research Institute

Clementon, New Jersey, United States

Site Status

NMDNJ

Newark, New Jersey, United States

Site Status

Bio Behavioral Health

Toms River, New Jersey, United States

Site Status

Zucker Hillside Hospital

Glen Oaks, New York, United States

Site Status

Neurobehavioral Research Company

Lawrence, New York, United States

Site Status

Midwest Clinical Research Center

Dayton, Ohio, United States

Site Status

Rakesh Ranjan, MD and Associates, Inc

Lyndhurst, Ohio, United States

Site Status

IPS Research Company

Oklahoma City, Oklahoma, United States

Site Status

CNS Research Institute

Philadelphia, Pennsylvania, United States

Site Status

Claghorn-Lesem Research Clinic

Bellaire, Texas, United States

Site Status

Grayline Clinical Drug Trials

Wichita Falls, Texas, United States

Site Status

International Clinical Research Associates

Richmond, Virginia, United States

Site Status

Northwest Clinical Research Center

Bellevue, Washington, United States

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 12242054 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11593077 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7682909 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29523415 (View on PubMed)

Related Links

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http://www.corcept.com

Corcept Therapeutics

Other Identifiers

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C-1073-07

Identifier Type: -

Identifier Source: org_study_id

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