An International Extension Study of Corlux for Recurrent Psychotic Symptoms in Psychotic Major Depression

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128505
• Other study ID #: C-1073-13
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2005
• Last updated: February 14, 2012
• Start date: August 2005
• Est. completion date: November 2006

Study information

• Verified date: February 2012
• Source: Corcept Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCroatia: Ministry of Health and Social CareSerbia and Montenegro: Agency for Drugs and Medicinal DevicesRomania: Ministry of Health, National Medicines AgencyBulgaria: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• Mifepristone

Locations

Country	Name	City	State
Bulgaria	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
Croatia	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
Romania	Mihai Dumitru Gheorge	Bucharest
Romania	Aurel Nirestean M.D./Ph.D	Targu Mures
Serbia	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

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Countries where clinical trial is conducted

Bulgaria,  Croatia,  Romania,  Serbia, 

References & Publications (3)

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. — View 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. — View 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. Review. Erratum in: Drugs 1993 Aug;46(2):268. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess the frequency of retreatment with Corlux in patients with PMD and qualitatively describe the psychotic symptoms for which retreatment is clinically indicated

External Links

•   Corcept Therapeutics