An International Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: placebo; Drug: Mifepristone

• Registration Number: NCT00146523
• 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 56 day study is to learn the safety and effectiveness of Corlux in patients who have been diagnosed with psychotic major depression (PMD).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-07
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-14
• Last Update Posted: 2012-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
matching placebo	placebo	-
mifepristone 600 mg	Mifepristone	-

Primary Outcome Measures

Name	Time	Method
The change in a measure of psychosis	screening and on Days 0, 7, 14, 28, 42, and 56

Secondary Outcome Measures

Name	Time	Method
The change in a measure of depression	screening and on Days 0, 7, 14, 28, 42, and 56

Trial Locations

Locations (19)

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

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

Mihai Dumitru Gheorge; 🇷🇴 Bucharest, Romania

Dragana Ignjatovic-Ristic M.D.; Kragujevac, Former Serbia and Montenegro

Ratomir Lisulov M.D.; Novi Sad, Former Serbia and Montenegro

Vladimir Diligenski M.D.; Belgrade, Former Serbia and Montenegro

Vladimir Paunovic M.D.; Belgrade, Former Serbia and Montenegro

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

Jelena Martinovic M.D.; Belgrade, Former Serbia and Montenegro

Ivana Timotijevic M.D.; Belgrade, Former Serbia and Montenegro

Georgi Popov M.D.; 🇧🇬 Varna, Bulgaria

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

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

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

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

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

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

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

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