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

This study has been completed.
Information provided by (Responsible Party):
Corcept Therapeutics Identifier:
First received: August 8, 2005
Last updated: February 14, 2012
Last verified: February 2012

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.

Condition Intervention Phase
Major Depressive Disorder
Psychotic Disorders
Drug: Mifepristone
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An International, Open-Label Extension Study of the Safety and Tolerability of CORLUX™ (Mifepristone) for Recurrent Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features

Resource links provided by NLM:

Further study details as provided by Corcept Therapeutics:

Primary Outcome Measures:
  • 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:
  • To assess the frequency of retreatment with Corlux in patients with PMD and qualitatively describe the psychotic symptoms for which retreatment is clinically indicated

Enrollment: 104
Study Start Date: August 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mifepristone Drug: Mifepristone


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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00128505

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

Additional Information:
Responsible Party: Corcept Therapeutics Identifier: NCT00128505     History of Changes
Other Study ID Numbers: C-1073-13
Study First Received: August 8, 2005
Last Updated: February 14, 2012
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: Ministry of Health, National Medicines Agency
Bulgaria: Ministry of Health

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
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Abortifacient Agents
Abortifacient Agents, Steroidal
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital
Contraceptives, Postcoital, Synthetic
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses processed this record on November 25, 2014