A United States Study of Corlux for Psychotic Symptoms in Psychotic Major Depression

Study Description

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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; Psychotic Disorders	Drug: Mifepristone; Drug: matching placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	257 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of CORLUX™ (Mifepristone) in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features
Study Start Date :	September 2004
Actual Primary Completion Date :	June 2006
Actual Study Completion Date :	June 2006

Arms and Interventions

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Arm	Intervention/treatment
Experimental: mifepristone 600 mg	Drug: Mifepristone; daily for 7 days
Placebo Comparator: matching placebo	Drug: matching placebo; daily for 7 days

Outcome Measures

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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 ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

Individuals eligible for enrollment into this study are male and female adult patients who:

• 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:

Individuals not eligible to be enrolled into the study are those who:

• 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

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  Show 23 Study Locations

Sponsors and Collaborators

Corcept Therapeutics

Investigators

Study Director:	Katherine Beebe, PhD	Corcept Therapeutics

More Information

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Additional Information:

Corcept Therapeutics 

Publications:

Belanoff JK, Rothschild AJ, Cassidy F, DeBattista C, Baulieu EE, Schold C, Schatzberg AF. An open label trial of C-1073 (mifepristone) for psychotic major depression. Biol Psychiatry. 2002 Sep 1;52(5):386-92.

Belanoff JK, Flores BH, Kalezhan M, Sund B, Schatzberg AF. Rapid reversal of psychotic depression using mifepristone. J Clin Psychopharmacol. 2001 Oct;21(5):516-21.

Brogden RN, Goa KL, Faulds D. Mifepristone. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential. Drugs. 1993 Mar;45(3):384-409. Review. Erratum in: Drugs 1993 Aug;46(2):268.

Responsible Party:	Corcept Therapeutics
ClinicalTrials.gov Identifier:	NCT00130676 History of Changes
Other Study ID Numbers:	C-1073-07
First Posted:	August 16, 2005
Last Update Posted:	February 15, 2012
Last Verified:	February 2012

Keywords provided by Corcept Therapeutics:

PMD; Psychotic Major Depression; Depression; Major Depression; Psychosis

Additional relevant MeSH terms:

Depressive Disorder; Depression; Depressive Disorder, Major; Mental Disorders; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Disease; Pathologic Processes; Mood Disorders; Behavioral Symptoms; Mifepristone; 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