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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.
First Received: September 2, 2005   Last Updated: February 22, 2007   History of Changes
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

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)

Resource links provided by NLM:


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

Additional Information:
Publications:
Study ID Numbers: C-1073-09
Study First Received: September 2, 2005
Last Updated: February 22, 2007
ClinicalTrials.gov Identifier: NCT00146523     History of Changes
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:
Depression
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Mifepristone
Depressive Disorder, Major
Contraceptives, Postcoital
Depressive Disorder
Hormones
Behavioral Symptoms
Schizophrenia
Mental Disorders
Mood Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

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

ClinicalTrials.gov processed this record on September 04, 2009