Clinical trial NCT00146523: An International Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Psychotic Major Depression
PMD
Depression
Major Depression
Psychosis
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: The change in a measure of psychosis
timeFrame: screening and on Days 0, 7, 14, 28, 42, and 56
Secondary outcomes:
measure: The change in a measure of depression
timeFrame: screening and on Days 0, 7, 14, 28, 42, and 56
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Georgy Koychev M.D.
city: Sofia
country: Bulgaria
facility: Luchezar G Hranov M.D.
city: Sofia
country: Bulgaria
facility: Svetlozar H Haralanov Ph.D.
city: Sofia
country: Bulgaria
facility: Vihra Milanova M.D.
city: Varna
country: Bulgaria
facility: Georgi Popov M.D.
city: Osijek
country: Croatia
facility: Pavo Filakovic M.D./Ph.D.
city: Rijeka
country: Croatia
facility: Ljiljana Moro M.D./Ph.D.
city: Split
country: Croatia
facility: Goran Dodig M.D./Ph.D.
city: Zagreb
country: Croatia
facility: Dubravka Kocijan-Hercigonja M.D.
city: Zagreb
country: Croatia
facility: Miro Jakovljevic M.D.
city: Zagreb
country: Croatia
facility: Vera Folnegovic-Smalc M.D./Ph.D.
city: Belgrade
country: Former Serbia and Montenegro
facility: Ivana Timotijevic M.D.
city: Belgrade
country: Former Serbia and Montenegro
facility: Jelena Martinovic M.D.
city: Belgrade
country: Former Serbia and Montenegro
facility: Vladimir Diligenski M.D.
city: Belgrade
country: Former Serbia and Montenegro
facility: Vladimir Paunovic M.D.
city: Kragujevac
country: Former Serbia and Montenegro
facility: Dragana Ignjatovic-Ristic M.D.
city: Novi Sad
country: Former Serbia and Montenegro
facility: Ratomir Lisulov M.D.
city: Bucharest
country: Romania
facility: Mihai Dumitru Gheorge
city: Targu Mures
country: Romania
facility: Aurel Nirestean M.D./Ph.D.
Study officials:
affiliation: Corcept Therapeutics
name: Katherine Beebe, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.