A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression - Tabular View

Tracking Information

First Received Date ^ICMJE

August 8, 2005

Last Updated Date

February 22, 2007

Start Date ^ICMJE

September 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The change in a measure of psychosis

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00128479 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The change in a measure of depression

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Efficacy of Three Dose Levels of CORLUX™ (Mifepristone) Plus an Antidepressant vs. Placebo Plus an Antidepressant in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features (PMD)

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).

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Major Depressive Disorder
Psychotic Disorders

Intervention ^ICMJE

Drug: Mifepristone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

440

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00128479

Responsible Party

Study ID Numbers ^ICMJE

C-1073-06

Study Sponsor ^ICMJE

Corcept Therapeutics

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Katherine Beebe, PhD

Corcept Therapeutics

Information Provided By

Corcept Therapeutics

Verification Date

September 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP