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

NCT ID: NCT00208156

Last Updated: 2012-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Depressive Disorder, Major

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mifepristone

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

Interventions

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Mifepristone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Completed participation through Day 56 in Corcept Therapeutics Protocol C-1073-07
* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corcept Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katherine Beebe, PhD

Role: STUDY_DIRECTOR

Corcept Therapeutics

Locations

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Cnri, Llc

San Diego, California, United States

Site Status

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Site Status

Robert Horne M.D.

Las Vegas, Nevada, United States

Site Status

CNS Research Institute (CRI)

Clementon, New Jersey, United States

Site Status

New Jersey Medical School - UMDNJ

Newark, New Jersey, United States

Site Status

BioBehavioral Health

Toms River, New Jersey, United States

Site Status

Zucker Hillside Hospital

Glen Oaks, New York, United States

Site Status

Neurobehavioral Research, Inc.

Lawrence, New York, United States

Site Status

IPS Research Company

Oklahoma City, Oklahoma, United States

Site Status

CNS Research Institute (CRI)

Philadelphia, Pennsylvania, United States

Site Status

Claghorn-Lesem Research Clinic

Bellaire, Texas, United States

Site Status

International Clinical Research Associates

Richmond, Virginia, United States

Site Status

Northwest Clinical Research Center

Bellevue, Washington, United States

Site Status

Countries

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United States

References

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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. doi: 10.1016/s0006-3223(02)01432-4.

Reference Type BACKGROUND
PMID: 12242054 (View on PubMed)

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. doi: 10.2165/00003495-199345030-00007.

Reference Type BACKGROUND
PMID: 7682909 (View on PubMed)

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. doi: 10.1097/00004714-200110000-00009.

Reference Type BACKGROUND
PMID: 11593077 (View on PubMed)

Related Links

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http://www.corcept.com

Corcept Therapeutics

Other Identifiers

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C-1073-10

Identifier Type: -

Identifier Source: org_study_id

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