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

Sponsor

Corcept Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00128479

Collaborator

(none)

443

Enrollment

Locations

Arms

Duration (Months)

10.1

Patients Per Site

0.4

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: mifepristone matched placebo Drug: mifepristone 600 mg Drug: mifepristone 1200 mg	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

443 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2004

Actual Primary Completion Date :

Jan 1, 2007

Actual Study Completion Date :

Jan 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mifepristone 300 mg	Drug: mifepristone mifepristone 300 mg daily for 7 dats
Placebo Comparator: placebo	Drug: mifepristone matched placebo daily for 7 days
Experimental: mifepristone 600 mg	Drug: mifepristone 600 mg mifepristone 600 mg daily for 7 days
Experimental: mifepristone 1200 mg	Drug: mifepristone 1200 mg mifepristone 1200 mg daily for 7 days

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

The change in a measure of depression [screen, Days 0,7, 14, 28, 42, 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	K&S Research Services	Little Rock	Arkansas	United States	72201
2	Center for Emotional Fitness	Cerritos	California	United States	90703
3	Harbor Medical Associates, Inc.	Fountain Valley	California	United States	92708
4	Synergy Clinical Research Center	National City	California	United States	91950
5	Excell Research	Oceanside	California	United States	92056
6	Pacific Clinical Research Medical Group	Riverside	California	United States	92506
7	AV Institute, Inc.	Torrance	California	United States	90505
8	Neuropsychiatric Institute of Orange County	Westminster	California	United States	92683
9	Geriatric and Adult Psych	Hamden	Connecticut	United States	06518
10	Comprehensive NeuroScience, Inc.	Washington	District of Columbia	United States	20016
11	Professional Clinical Research Inc.	Ft. Lauderdale	Florida	United States	33319
12	Amit Vijapura, MD	Jacksonville	Florida	United States	32256
13	Tukoi Inst for Clinical Research	Miami	Florida	United States	33180
14	Bioquan Research Group, Inc.	North Miami	Florida	United States	33161
15	Scientific Clinical Research, Inc.	North Miami	Florida	United States	33161
16	Mark Ashby, MD	Sebring	Florida	United States	33870
17	Stedman Clinical Trials, LLC	Tampa	Florida	United States	33613
18	Hawaii Clinical Research Center	Honolulu	Hawaii	United States	96826
19	Midwest Center for Neurobehavioral Medicine	Oakbrook Terrace	Illinois	United States	60181
20	Peryam and Kroll Health Care Research	Schaumburg	Illinois	United States	60194
21	Clintell, Inc.	Skokie	Illinois	United States	60077
22	CTT Research	Prairie Village	Kansas	United States	66206
23	Lake Charles Clinical Trials	Lake Charles	Louisiana	United States	70601
24	Louisiana Research Associates, Inc	New Orleans	Louisiana	United States	70114
25	LSU Health Sciences Center	Shreveport	Louisiana	United States	71103
26	Saaid Khojasteh & Assoc, Inc	St. Charles	Missouri	United States	63301
27	Medex Healthcare Research	St. Louis	Missouri	United States	63108
28	Albuquerque Neuroscience, Inc.	Albuquerque	New Mexico	United States	87102
29	Anxiety and Depression Clinic at Montefiore Medical Center	Bronx	New York	United States	10467
30	Brooklyn Medical Institute	Brooklyn	New York	United States	11223
31	Advanced Bio-Behavioral Science, Inc	Elmsford	New York	United States	10523
32	Saint Vincent Catholic Medical Centers of New York	Staten Island	New York	United States	10304
33	Lutheran Hospital	Cleveland	Ohio	United States	44109
34	Southwest Cleveland Sleep Center, Inc.	Middleburg Heights	Ohio	United States	44130
35	IPS Research Company	Oklahoma City	Oklahoma	United States	73101
36	Crossroads Counseling & Consulting Associates	Moon Township	Pennsylvania	United States	15108
37	CNS Research Institute (CRI)	Philadelphia	Pennsylvania	United States	19149
38	Segal Institute	Charleston	South Carolina	United States	29405
39	Harmony Research	Johnson City	Tennessee	United States	37601
40	UT Southwestern Medical Center	Dallas	Texas	United States	75235
41	The Cedars Hospital, InSite Clinical Research	Desoto	Texas	United States	75115
42	Felin-Jennings Clinic	Houston	Texas	United States	77074
43	R&D Clinical Research, Inc.	Lake Jackson	Texas	United States	77566
44	America's Doctor/Essential Doctor, Inc	Seattle	Washington	United States	98126