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

Major Depressive Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128479
• Other study ID #: C-1073-06
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2005
• Last updated: February 14, 2012
• Start date: September 2004
• Est. completion date: January 2007

Study information

• Verified date: February 2012
• Source: Corcept Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• mifepristone
mifepristone 300 mg daily for 7 dats
• mifepristone matched placebo
daily for 7 days
• mifepristone 600 mg
mifepristone 600 mg daily for 7 days
• mifepristone 1200 mg
mifepristone 1200 mg daily for 7 days

Locations

Country	Name	City	State
United States	Albuquerque Neuroscience, Inc.	Albuquerque	New Mexico
United States	Anxiety and Depression Clinic at Montefiore Medical Center	Bronx	New York
United States	Brooklyn Medical Institute	Brooklyn	New York
United States	Center for Emotional Fitness	Cerritos	California
United States	Segal Institute	Charleston	South Carolina
United States	Lutheran Hospital	Cleveland	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	The Cedars Hospital, InSite Clinical Research	Desoto	Texas
United States	Advanced Bio-Behavioral Science, Inc	Elmsford	New York
United States	Harbor Medical Associates, Inc.	Fountain Valley	California
United States	Professional Clinical Research Inc.	Ft. Lauderdale	Florida
United States	Geriatric and Adult Psych	Hamden	Connecticut
United States	Hawaii Clinical Research Center	Honolulu	Hawaii
United States	Felin-Jennings Clinic	Houston	Texas
United States	Amit Vijapura, MD	Jacksonville	Florida
United States	Harmony Research	Johnson City	Tennessee
United States	Lake Charles Clinical Trials	Lake Charles	Louisiana
United States	R&D Clinical Research, Inc.	Lake Jackson	Texas
United States	K&S Research Services	Little Rock	Arkansas
United States	Tukoi Inst for Clinical Research	Miami	Florida
United States	Southwest Cleveland Sleep Center, Inc.	Middleburg Heights	Ohio
United States	Crossroads Counseling & Consulting Associates	Moon Township	Pennsylvania
United States	Synergy Clinical Research Center	National City	California
United States	Louisiana Research Associates, Inc	New Orleans	Louisiana
United States	Bioquan Research Group, Inc.	North Miami	Florida
United States	Scientific Clinical Research, Inc.	North Miami	Florida
United States	Midwest Center for Neurobehavioral Medicine	Oakbrook Terrace	Illinois
United States	Excell Research	Oceanside	California
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	CNS Research Institute (CRI)	Philadelphia	Pennsylvania
United States	CTT Research	Prairie Village	Kansas
United States	Pacific Clinical Research Medical Group	Riverside	California
United States	Peryam and Kroll Health Care Research	Schaumburg	Illinois
United States	America's Doctor/Essential Doctor, Inc	Seattle	Washington
United States	Mark Ashby, MD	Sebring	Florida
United States	LSU Health Sciences Center	Shreveport	Louisiana
United States	Clintell, Inc.	Skokie	Illinois
United States	Saaid Khojasteh & Assoc, Inc	St. Charles	Missouri
United States	Medex Healthcare Research	St. Louis	Missouri
United States	Saint Vincent Catholic Medical Centers of New York	Staten Island	New York
United States	Stedman Clinical Trials, LLC	Tampa	Florida
United States	AV Institute, Inc.	Torrance	California
United States	Comprehensive NeuroScience, Inc.	Washington	District of Columbia
United States	Neuropsychiatric Institute of Orange County	Westminster	California

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. Review. Erratum in: Drugs 1993 Aug;46(2):268. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in a measure of psychosis		screen, Days 0, 7, 14, 28, 42, 56	Yes
Secondary	The change in a measure of depression		screen, Days 0,7, 14, 28, 42, 56	Yes

External Links

•   Corcept Therapeutics