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

Phase 3

Completed

• Conditions: Major Depressive Disorder; Psychotic Disorders
• Interventions: Drug: Mifepristone

• Registration Number: NCT00128505
• Lead Sponsor: Corcept Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-08
• Study First Submitted QC: 2005-08-08
• Study First Posted: 2005-08-10
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-14
• Last Update Posted: 2012-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mifepristone	Mifepristone	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To assess the frequency of retreatment with Corlux in patients with PMD and qualitatively describe the psychotic symptoms for which retreatment is clinically indicated

Trial Locations

Locations (19)

Svetlozar H Haralanov Ph.D.; 🇧🇬 Sofia, Bulgaria

Vera Folnegovic-Smalc M.D/Ph.D; 🇭🇷 Zagreb, Croatia

Vihra Milanova M.D.; 🇧🇬 Sofia, Bulgaria

Mihai Dumitru Gheorge; 🇷🇴 Bucharest, Romania

Aurel Nirestean M.D./Ph.D; 🇷🇴 Targu Mures, Romania

Jelena Martinovic M.D.; 🇷🇸 Belgrade, Serbia

Vladimir Diligenski M.D.; 🇷🇸 Belgrade, Serbia

Dragana Ignjatovic-Ristic M.D.; 🇷🇸 Kragujevac, Serbia

Georgy Koychev M.D.; 🇧🇬 Sofia, Bulgaria

Georgi Popov M.D.; 🇧🇬 Varna, Bulgaria

Vladimir Paunovic M.D.; 🇷🇸 Belgrade, Serbia

Miro Jakovljevic M.D.; 🇭🇷 Zagreb, Croatia

Ratomir Lisulov M.D.; 🇷🇸 Novi Sad, Serbia

Dubravka Kocijan-Hercigonja M.D.; 🇭🇷 Zagreb, Croatia

Ljiljana Moro M.D./Ph.D.; 🇭🇷 Rijeka, Croatia

Luchezar G Hranov M.D.; 🇧🇬 Sofia, Bulgaria

Goran Dodig M.D./Ph.D.; 🇭🇷 Split, Croatia

Ivana Timotijevic M.D.; 🇷🇸 Belgrade, Serbia

Pavo Filakovic M.D./Ph.D.; 🇭🇷 Osijek, Croatia