An International Extension Study of Corlux for Recurrent 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

August 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To evaluate the safety and tolerability of Corlux (mifepristone) for the treatment of recurrent psychotic symptoms with major depression with psychotic features (PMD) who previously participated in Corcept Therapeutics Protocol C-1073-09

Original Primary Outcome Measures ^ICMJE

To evaluate the safety and tolerability of Corlux (mifepristone) for the treatment of recurrent psychotic symptoms with Major Depression with Psychotic Features (PMD) who previously participated in Corcept Therapeutics protocol C-1073-09.

Change History

Complete list of historical versions of study NCT00128505 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess the frequency of retreatment with Corlux in patients with PMD and qualitatively describe the psychotic symptoms for which retreatment is clinically indicated

Original Secondary Outcome Measures ^ICMJE

To assess the frequency of retreatment with Corlux in patients with PMD and qualitatively describe the psychotic symptoms for which retreatment is clinically indicated.

Descriptive Information

Brief Title ^ICMJE

An International Extension Study of Corlux for Recurrent Psychotic Symptoms in Psychotic Major Depression

Official Title ^ICMJE

An International, Open-Label Extension Study of the Safety and Tolerability of CORLUX™ (Mifepristone) for Recurrent Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features

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 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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety 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

110

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Completed participation through Day 56 in Corcept Therapeutics Protocol C-1073-09
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)

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

Bulgaria, Croatia, Former Serbia and Montenegro, Romania

Administrative Information

NCT ID ^ICMJE

NCT00128505

Responsible Party

Study ID Numbers ^ICMJE

C-1073-13

Study Sponsor ^ICMJE

Corcept Therapeutics

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Katherine Beebe, PhD

Corcept Therapeutics

Information Provided By

Corcept Therapeutics

Verification Date

February 2007

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