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

This study has been completed.

Sponsored by: Corcept Therapeutics
Information provided by: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT00146523
  Purpose

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 Intervention Phase
Major Depressive Disorder
Drug: Mifepristone
Phase III

MedlinePlus related topics:   Depression    Psychotic Disorders   

ChemIDplus related topics:   Mifepristone   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Corcept Therapeutics:

Primary Outcome Measures:
  • The change in a measure of psychosis

Secondary Outcome Measures:
  • The change in a measure of depression

Estimated Enrollment:   280
Study Start Date:   May 2005

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146523

Locations
Bulgaria
Svetlozar H Haralanov Ph.D.    
      Sofia, Bulgaria
Luchezar G Hranov M.D.    
      Sofia, Bulgaria
Georgy Koychev M.D.    
      Sofia, Bulgaria
Georgi Popov M.D.    
      Varna, Bulgaria
Vihra Milanova M.D.    
      Sofia, Bulgaria
Croatia
Goran Dodig M.D./Ph.D.    
      Split, Croatia
Pavo Filakovic M.D./Ph.D.    
      Osijek, Croatia
Vera Folnegovic-Smalc M.D./Ph.D.    
      Zagreb, Croatia
Miro Jakovljevic M.D.    
      Zagreb, Croatia
Ljiljana Moro M.D./Ph.D.    
      Rijeka, Croatia
Dubravka Kocijan-Hercigonja M.D.    
      Zagreb, Croatia
Romania
Aurel Nirestean M.D./Ph.D.    
      Targu Mures, Romania
Mihai Dumitru Gheorge    
      Bucharest, Romania
Serbia and Montenegro
Vladimir Diligenski M.D.    
      Belgrade, Serbia and Montenegro
Jelena Martinovic M.D.    
      Belgrade, Serbia and Montenegro
Ratomir Lisulov M.D.    
      Novi Sad, Serbia and Montenegro
Vladimir Paunovic M.D.    
      Belgrade, Serbia and Montenegro
Ivana Timotijevic M.D.    
      Belgrade, Serbia and Montenegro
Dragana Ignjatovic-Ristic M.D.    
      Kragujevac, Serbia and Montenegro

Sponsors and Collaborators
Corcept Therapeutics

Investigators
Study Director:     Katherine Beebe, PhD     Corcept Therapeutics    
  More Information

Corcept Therapeutics  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   C-1073-09
First Received:   September 2, 2005
Last Updated:   February 22, 2007
ClinicalTrials.gov Identifier:   NCT00146523
Health Authority:   United States: Food and Drug Administration;   Croatia: Ministry of Health and Social Care;   Serbia and Montenegro: Agency for Drugs and Medicinal Devices;   Romania: National Medicines Agency;   Bulgaria: Ministry of Health

Keywords provided by Corcept Therapeutics:
Psychotic Major Depression  
PMD  
Depression  
Major Depression  
Psychosis  

Study placed in the following topic categories:
Schizophrenia
Depression
Mental Disorders
Mood Disorders
Mifepristone
Psychotic Disorders
Depressive Disorder, Major
Depressive Disorder
Schizophrenia and Disorders with Psychotic Features
Behavioral Symptoms

Additional relevant MeSH terms:
Abortifacient Agents, Steroidal
Contraceptives, Postcoital, Synthetic
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Contraceptives, Postcoital
Luteolytic Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Menstruation-Inducing Agents
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on September 05, 2008




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