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

Sponsor

Corcept Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00208156

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

6.7

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 study is to allow patients who have already participated in an earlier 8 week study of Corlux versus placebo (an inactive pill) to receive additional courses of treatment with Corlux periodically if a psychotic episode should reappear during a period of one year.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder, Major	Drug: Mifepristone	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

87 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label Extension Study of the Safety and Tolerability of CORLUX™ (Mifepristone) for Recurrent Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features

Study Start Date :

May 1, 2005

Actual Primary Completion Date :

Nov 1, 2006

Actual Study Completion Date :

Nov 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mifepristone	Drug: Mifepristone

Arm

Intervention/Treatment

Experimental: mifepristone

Drug: Mifepristone

Outcome Measures

Primary Outcome Measures

To evaluate the safety and tolerability of Corlux (mifepristone) for the treatment of recurrent psychotic symptoms with major depression with psychotic features (PMD) who previously participated in Corcept Therapeutics Protocol C-1073-07 []

Secondary Outcome Measures

To assess the frequency of retreatment with Corlux in patients with PMD and qualitatively describe the psychotic symptoms for which retreatment is clinically indicated []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Completed participation through Day 56 in Corcept Therapeutics Protocol C-1073-07
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:

Have a major medical problem
Have a history of an allergic reaction to Corlux (C-1073, mifepristone)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cnri, Llc	San Diego	California	United States	92126
2	Atlanta Center for Medical Research	Atlanta	Georgia	United States	30308
3	Robert Horne M.D.	Las Vegas	Nevada	United States	89102
4	CNS Research Institute (CRI)	Clementon	New Jersey	United States	08021
5	New Jersey Medical School - UMDNJ	Newark	New Jersey	United States	07101
6	BioBehavioral Health	Toms River	New Jersey	United States	08755
7	Zucker Hillside Hospital	Glen Oaks	New York	United States	11004
8	Neurobehavioral Research, Inc.	Lawrence	New York	United States	11559
9	IPS Research Company	Oklahoma City	Oklahoma	United States	73101
10	CNS Research Institute (CRI)	Philadelphia	Pennsylvania	United States	19149
11	Claghorn-Lesem Research Clinic	Bellaire	Texas	United States	77401
12	International Clinical Research Associates	Richmond	Virginia	United States	23229
13	Northwest Clinical Research Center	Bellevue	Washington	United States	98004