Clinical trial NCT00128505: An International Extension Study of Corlux for Recurrent Psychotic Symptoms in Psychotic Major Depression
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Psychotic Disorders
Keywords: PMD
Depression
Psychosis
Psychotic Major Depression
Major Depression
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-08-10
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Have a major medical problem
* Have a history of an allergic reaction to CORLUX (C-1073, mifepristone)

Primary outcomes:
measure: 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:
measure: To assess the frequency of retreatment with Corlux in patients with PMD and qualitatively describe the psychotic symptoms for which retreatment is clinically indicated
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: Bucharest
country: Romania
facility: Mihai Dumitru Gheorge
city: Targu Mures
country: Romania
facility: Aurel Nirestean M.D./Ph.D
city: Belgrade
country: Serbia
facility: Ivana Timotijevic M.D.
city: Belgrade
country: Serbia
facility: Jelena Martinovic M.D.
city: Belgrade
country: Serbia
facility: Vladimir Diligenski M.D.
city: Belgrade
country: Serbia
facility: Vladimir Paunovic M.D.
city: Kragujevac
country: Serbia
facility: Dragana Ignjatovic-Ristic M.D.
city: Novi Sad
country: Serbia
facility: Ratomir Lisulov M.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.