An International Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression
NCT ID: NCT00146523
Last Updated: 2012-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
247 participants
INTERVENTIONAL
2005-05-31
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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mifepristone 600 mg
Mifepristone
matching placebo
placebo
Interventions
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Mifepristone
placebo
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Have previously participated in a Corlux (C-1073, mifepristone) clinical trial
* Have a history of an allergic reaction to Corlux (C-1073, mifepristone).
18 Years
75 Years
ALL
No
Sponsors
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Corcept Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Katherine Beebe, PhD
Role: STUDY_DIRECTOR
Corcept Therapeutics
Locations
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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
Countries
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References
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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.
Brogden 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.
Belanoff 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.
Block 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.
Related Links
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Corcept Therapeutics
Other Identifiers
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C-1073-09
Identifier Type: -
Identifier Source: org_study_id
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