An International Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression
An International, Double-Blind, Placebo-Controlled, Study of the Efficacy and Safety of CORLUX™ (Mifepristone) vs. Placebo in the Treatment of Psychotic Symptoms in Patients With Psychotic Major Depression (PMD)
1 other identifier
interventional
247
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 56 day study is to learn the safety and effectiveness of Corlux in patients who have been diagnosed with psychotic major depression (PMD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 major-depressive-disorder
Started May 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
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 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFebruary 15, 2012
February 1, 2012
1.2 years
September 2, 2005
February 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change in a measure of psychosis
screening and on Days 0, 7, 14, 28, 42, and 56
Secondary Outcomes (1)
The change in a measure of depression
screening and on Days 0, 7, 14, 28, 42, and 56
Study Arms (2)
mifepristone 600 mg
EXPERIMENTALmatching placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Are 18 to 75 years of age
- Have a diagnosis of major depressive disorder with psychotic features (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition \[DSM IV\] 296.24 or 296.34)
- Are able to provide written informed consent.
You may not qualify if:
- Have a major medical problem
- Have previously participated in a Corlux (C-1073, mifepristone) clinical trial
- 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 and Montenegro
Jelena Martinovic M.D.
Belgrade, Serbia and Montenegro
Vladimir Diligenski M.D.
Belgrade, Serbia and Montenegro
Vladimir Paunovic M.D.
Belgrade, Serbia and Montenegro
Dragana Ignjatovic-Ristic M.D.
Kragujevac, Serbia and Montenegro
Ratomir Lisulov M.D.
Novi Sad, Serbia and Montenegro
Related Publications (4)
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: 11593077BACKGROUNDBlock TS, Kushner H, Kalin N, Nelson C, Belanoff J, Schatzberg A. Combined Analysis of Mifepristone for Psychotic Depression: Plasma Levels Associated With Clinical Response. Biol Psychiatry. 2018 Jul 1;84(1):46-54. doi: 10.1016/j.biopsych.2018.01.008. Epub 2018 Jan 31.
PMID: 29523415DERIVED
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
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 7, 2005
Study Start
May 1, 2005
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
February 15, 2012
Record last verified: 2012-02