An International Extension Study of Corlux for Recurrent Psychotic Symptoms in Psychotic Major Depression
An International, 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
104
4 countries
19
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 major-depressive-disorder
Started Aug 2005
Shorter than P25 for phase_3 major-depressive-disorder
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 8, 2005
CompletedFirst Posted
Study publicly available on registry
August 10, 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
1.3 years
August 8, 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-1073-09
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-1073-09
- 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 (19)
Georgy Koychev M.D.
Sofia, Bulgaria
Luchezar G Hranov M.D.
Sofia, Bulgaria
Svetlozar H Haralanov Ph.D.
Sofia, Bulgaria
Vihra Milanova M.D.
Sofia, Bulgaria
Georgi Popov M.D.
Varna, Bulgaria
Pavo Filakovic M.D./Ph.D.
Osijek, Croatia
Ljiljana Moro M.D./Ph.D.
Rijeka, Croatia
Goran Dodig M.D./Ph.D.
Split, Croatia
Dubravka Kocijan-Hercigonja M.D.
Zagreb, Croatia
Miro Jakovljevic M.D.
Zagreb, Croatia
Vera Folnegovic-Smalc M.D/Ph.D
Zagreb, Croatia
Mihai Dumitru Gheorge
Bucharest, Romania
Aurel Nirestean M.D./Ph.D
Târgu Mureş, Romania
Ivana Timotijevic M.D.
Belgrade, Serbia
Jelena Martinovic M.D.
Belgrade, Serbia
Vladimir Diligenski M.D.
Belgrade, Serbia
Vladimir Paunovic M.D.
Belgrade, Serbia
Dragana Ignjatovic-Ristic M.D.
Kragujevac, Serbia
Ratomir Lisulov M.D.
Novi Sad, Serbia
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
August 8, 2005
First Posted
August 10, 2005
Study Start
August 1, 2005
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
February 15, 2012
Record last verified: 2012-02