A United States Study of Corlux for Psychotic Symptoms in Psychotic Major Depression - Full Text View

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 Psychotic Disorders	Drug: Mifepristone Drug: matching 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:	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

Resource links provided by NLM:

MedlinePlus related topics: Depression Mental Disorders Psychotic Disorders

Drug Information available for: Mifepristone

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:	257
Study Start Date:	September 2004
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: mifepristone 600 mg	Drug: Mifepristone daily for 7 days
Placebo Comparator: matching placebo	Drug: matching placebo daily for 7 days

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130676

Show 23 Study Locations

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:

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
Study First Received:	August 12, 2005
Last Updated:	February 14, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Corcept Therapeutics:

PMD
Psychotic Major Depression
Depression
Major Depression
Psychosis

Additional relevant MeSH terms:

Depression
Depressive Disorder
Psychotic Disorders
Mental 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