A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression

NCT ID: NCT00128479

Last Updated: 2012-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 443 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2007-01-31

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).

Conditions

Major Depressive Disorder; Psychotic Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

mifepristone 300 mg

Group Type: EXPERIMENTAL

mifepristone

Intervention Type: DRUG

mifepristone 300 mg daily for 7 dats

placebo

Group Type: PLACEBO_COMPARATOR

mifepristone matched placebo

Intervention Type: DRUG

daily for 7 days

mifepristone 600 mg

Group Type: EXPERIMENTAL

mifepristone 600 mg

Intervention Type: DRUG

mifepristone 600 mg daily for 7 days

mifepristone 1200 mg

Group Type: EXPERIMENTAL

mifepristone 1200 mg

Intervention Type: DRUG

mifepristone 1200 mg daily for 7 days

Interventions

mifepristone

mifepristone 300 mg daily for 7 dats

Intervention Type: DRUG

mifepristone matched placebo

daily for 7 days

Intervention Type: DRUG

mifepristone 600 mg

mifepristone 600 mg daily for 7 days

Intervention Type: DRUG

mifepristone 1200 mg

mifepristone 1200 mg daily for 7 days

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corcept Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine Beebe, PhD

Role: STUDY_DIRECTOR

Corcept Therapeutics

Locations

K&S Research Services

Little Rock, Arkansas, United States

Center for Emotional Fitness

Cerritos, California, United States

Harbor Medical Associates, Inc.

Fountain Valley, California, United States

Synergy Clinical Research Center

National City, California, United States

Excell Research

Oceanside, California, United States

Pacific Clinical Research Medical Group

Riverside, California, United States

AV Institute, Inc.

Torrance, California, United States

Neuropsychiatric Institute of Orange County

Westminster, California, United States

Geriatric and Adult Psych

Hamden, Connecticut, United States

Comprehensive NeuroScience, Inc.

Washington D.C., District of Columbia, United States

Professional Clinical Research Inc.

Fort Lauderdale, Florida, United States

Amit Vijapura, MD

Jacksonville, Florida, United States

Tukoi Inst for Clinical Research

Miami, Florida, United States

Bioquan Research Group, Inc.

North Miami, Florida, United States

Scientific Clinical Research, Inc.

North Miami, Florida, United States

Mark Ashby, MD

Sebring, Florida, United States

Stedman Clinical Trials, LLC

Tampa, Florida, United States

Hawaii Clinical Research Center

Honolulu, Hawaii, United States

Midwest Center for Neurobehavioral Medicine

Oakbrook Terrace, Illinois, United States

Peryam and Kroll Health Care Research

Schaumburg, Illinois, United States

Clintell, Inc.

Skokie, Illinois, United States

CTT Research

Prairie Village, Kansas, United States

Lake Charles Clinical Trials

Lake Charles, Louisiana, United States

Louisiana Research Associates, Inc

New Orleans, Louisiana, United States

LSU Health Sciences Center

Shreveport, Louisiana, United States

Saaid Khojasteh & Assoc, Inc

Saint Charles, Missouri, United States

Medex Healthcare Research

St Louis, Missouri, United States

Albuquerque Neuroscience, Inc.

Albuquerque, New Mexico, United States

Brooklyn Medical Institute

Brooklyn, New York, United States

Advanced Bio-Behavioral Science, Inc

Elmsford, New York, United States

Saint Vincent Catholic Medical Centers of New York

Staten Island, New York, United States

Anxiety and Depression Clinic at Montefiore Medical Center

The Bronx, New York, United States

Lutheran Hospital

Cleveland, Ohio, United States

Southwest Cleveland Sleep Center, Inc.

Middleburg Heights, Ohio, United States

IPS Research Company

Oklahoma City, Oklahoma, United States

Crossroads Counseling & Consulting Associates

Moon Township, Pennsylvania, United States

CNS Research Institute (CRI)

Philadelphia, Pennsylvania, United States

Segal Institute

Charleston, South Carolina, United States

Harmony Research

Johnson City, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

The Cedars Hospital, InSite Clinical Research

DeSoto, Texas, United States

Felin-Jennings Clinic

Houston, Texas, United States

R&D Clinical Research, Inc.

Lake Jackson, Texas, United States

America's Doctor/Essential Doctor, Inc

Seattle, Washington, United States

Countries

United States

References

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)

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)

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.

Reference Type: DERIVED

PMID: 34875106 (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

http://www.corcept.com

Corcept Therapeutics

Other Identifiers

C-1073-06

Identifier Type: -

Identifier Source: org_study_id