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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00146523
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : February 15, 2012
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Mifepristone Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 247 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: mifepristone 600 mg Drug: Mifepristone
Placebo Comparator: matching placebo Drug: placebo

Primary Outcome Measures :
  1. The change in a measure of psychosis [ Time Frame: screening and on Days 0, 7, 14, 28, 42, and 56 ]

Secondary Outcome Measures :
  1. The change in a measure of depression [ Time Frame: screening and on Days 0, 7, 14, 28, 42, and 56 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00146523

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, Bulgaria
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, Croatia
Former Serbia and Montenegro
Ivana Timotijevic M.D.
Belgrade, Former Serbia and Montenegro
Jelena Martinovic M.D.
Belgrade, Former Serbia and Montenegro
Vladimir Diligenski M.D.
Belgrade, Former Serbia and Montenegro
Vladimir Paunovic M.D.
Belgrade, Former Serbia and Montenegro
Dragana Ignjatovic-Ristic M.D.
Kragujevac, Former Serbia and Montenegro
Ratomir Lisulov M.D.
Novi Sad, Former Serbia and Montenegro
Mihai Dumitru Gheorge
Bucharest, Romania
Aurel Nirestean M.D./Ph.D.
Targu Mures, Romania
Sponsors and Collaborators
Corcept Therapeutics
Study Director: Katherine Beebe, PhD Corcept Therapeutics

Additional Information:
Responsible Party: Corcept Therapeutics Identifier: NCT00146523     History of Changes
Other Study ID Numbers: C-1073-09
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: February 15, 2012
Last Verified: February 2012

Keywords provided by Corcept Therapeutics:
Psychotic Major Depression
Major Depression

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mental Disorders
Psychotic Disorders
Behavioral Symptoms
Mood Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents