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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.
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics
ClinicalTrials.gov Identifier:
NCT00146523
First received: September 2, 2005
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  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
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Corcept Therapeutics:

Primary Outcome Measures:
  • The change in a measure of psychosis [ Time Frame: screening and on Days 0, 7, 14, 28, 42, and 56 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The change in a measure of depression [ Time Frame: screening and on Days 0, 7, 14, 28, 42, and 56 ] [ Designated as safety issue: Yes ]

Enrollment: 247
Study Start Date: May 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mifepristone 600 mg Drug: Mifepristone
Placebo Comparator: matching placebo Drug: placebo

  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
Vihra Milanova M.D.
Sofia, Bulgaria
Georgi Popov M.D.
Varna, Bulgaria
Croatia
Pavo Filakovic M.D./Ph.D.
Osijek, Croatia
Ljiljana Moro M.D./Ph.D.
Rijeka, Croatia
Goran Dodig M.D./Ph.D.
Split, Croatia
Vera Folnegovic-Smalc M.D./Ph.D.
Zagreb, Croatia
Miro Jakovljevic M.D.
Zagreb, Croatia
Dubravka Kocijan-Hercigonja M.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
Romania
Mihai Dumitru Gheorge
Bucharest, Romania
Aurel Nirestean M.D./Ph.D.
Targu Mures, Romania
Sponsors and Collaborators
Corcept Therapeutics
Investigators
Study Director: Katherine Beebe, PhD Corcept Therapeutics
  More Information

Additional Information:
Corcept Therapeutics  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT00146523     History of Changes
Other Study ID Numbers: C-1073-09
Study First Received: September 2, 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: National Medicines Agency
Bulgaria: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 22, 2013