A United States Extension Study of Corlux for Recurrent Psychotic Symptoms in Psychotic Major Depression
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
1 other identifier
interventional
87
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2005
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedFebruary 15, 2012
February 1, 2012
1.5 years
September 13, 2005
February 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To assess the frequency of retreatment with Corlux in patients with PMD and qualitatively describe the psychotic symptoms for which retreatment is clinically indicated
Study Arms (1)
mifepristone
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Have a major medical problem
- Have a history of an allergic reaction to Corlux (C-1073, mifepristone)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Cnri, Llc
San Diego, California, 92126, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Robert Horne M.D.
Las Vegas, Nevada, 89102, United States
CNS Research Institute (CRI)
Clementon, New Jersey, 08021, United States
New Jersey Medical School - UMDNJ
Newark, New Jersey, 07101, United States
BioBehavioral Health
Toms River, New Jersey, 08755, United States
Zucker Hillside Hospital
Glen Oaks, New York, 11004, United States
Neurobehavioral Research, Inc.
Lawrence, New York, 11559, United States
IPS Research Company
Oklahoma City, Oklahoma, 73101, United States
CNS Research Institute (CRI)
Philadelphia, Pennsylvania, 19149, United States
Claghorn-Lesem Research Clinic
Bellaire, Texas, 77401, United States
International Clinical Research Associates
Richmond, Virginia, 23229, United States
Northwest Clinical Research Center
Bellevue, Washington, 98004, United States
Related Publications (3)
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.
PMID: 12242054BACKGROUNDBrogden 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.
PMID: 7682909BACKGROUNDBelanoff 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.
PMID: 11593077BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Katherine Beebe, PhD
Corcept Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
May 1, 2005
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
February 15, 2012
Record last verified: 2012-02