Expired Study
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Bellevue, Washington 98004


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).


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)


Study is Available At:


Original ID:

C-1073-07


NCT ID:

NCT00130676


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Corcept Therapeutics


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

257


Enrollment Type:

Actual


Overall Contact Information

Official Name:Katherine Beebe, PhD
Study Director
Corcept Therapeutics

Study Dates

Start Date:September 2004
Completion Date:June 2006
Completion Type:Actual
Primary Completion Date:June 2006
Primary Completion Type:Actual
Verification Date:February 2012
Last Changed Date:February 14, 2012
First Received Date:August 12, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:The change in a measure of psychosis
Time Frame:screening and on Days 0, 7, 14, 28, 42, and 56
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:The change in a measure of depression
Time Frame:screening and on Days 0, 7, 14, 28, 42, and 56
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:Mifepristone
Description:daily for 7 days
Arm Name:mifepristone 600 mg
Intervention Type:Drug
Name:matching placebo
Description:daily for 7 days
Arm Name:matching placebo

Study Arms

Study Arm Type:Experimental
Arm Name:mifepristone 600 mg
Study Arm Type:Placebo Comparator
Arm Name:matching placebo

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Corcept Therapeutics

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:12242054
Reference Type:Reference
Citation: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.
PMID:11593077
Reference Type:Reference
Citation: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.
PMID:7682909

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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