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

Sponsor

Corcept Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00130676

Collaborator

(none)

257

Enrollment

Locations

Arms

Duration (Months)

11.2

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Psychotic Disorders	Drug: Mifepristone Drug: matching placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

257 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2004

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Jun 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mifepristone 600 mg	Drug: Mifepristone daily for 7 days
Placebo Comparator: matching placebo	Drug: matching placebo daily for 7 days

Arm

Intervention/Treatment

Experimental: mifepristone 600 mg

Drug: Mifepristone

daily for 7 days

Placebo Comparator: matching placebo

Drug: matching placebo

daily for 7 days

Outcome Measures

Primary Outcome Measures

The change in a measure of psychosis [screening and on Days 0, 7, 14, 28, 42, and 56]

Secondary Outcome Measures

The change in a measure of depression [screening and on Days 0, 7, 14, 28, 42, and 56]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CNRI-LA	Pico Rivera	California	United States	90660
2	Behavioral Health 2000, LLC	Riverside	California	United States	92506
3	Cnri, Llc	San Diego	California	United States	92126
4	University of Florida Clinical Trials	Jacksonville	Florida	United States	32257
5	Quantum Laboratories/Memory Disorder Center	Pompano Beach	Florida	United States	33064
6	Atlanta Center for Medical Research	Atlanta	Georgia	United States	30308
7	American Medical Research, Inc.	Oak Brook	Illinois	United States	60523
8	Valle Vista Health System	Greenwood	Indiana	United States	46143
9	Psychopharmacology Research	Farmington Hills	Michigan	United States	48334
10	Robert Horne, MD	Las Vegas	Nevada	United States	89102
11	CNS Research Institute	Clementon	New Jersey	United States	08021
12	NMDNJ	Newark	New Jersey	United States	07101
13	Bio Behavioral Health	Toms River	New Jersey	United States	08755
14	Zucker Hillside Hospital	Glen Oaks	New York	United States	11004
15	Neurobehavioral Research Company	Lawrence	New York	United States	11559
16	Midwest Clinical Research Center	Dayton	Ohio	United States	45408
17	Rakesh Ranjan, MD and Associates, Inc	Lyndhurst	Ohio	United States	44124
18	IPS Research Company	Oklahoma City	Oklahoma	United States	73101
19	CNS Research Institute	Philadelphia	Pennsylvania	United States	19149
20	Claghorn-Lesem Research Clinic	Bellaire	Texas	United States	77401
21	Grayline Clinical Drug Trials	Wichita Falls	Texas	United States	76309
22	International Clinical Research Associates	Richmond	Virginia	United States	23229
23	Northwest Clinical Research Center	Bellevue	Washington	United States	98004