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

February 14, 2012 updated by: Corcept Therapeutics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria
        • Georgy Koychev M.D.
      • Sofia, Bulgaria
        • Luchezar G Hranov M.D.
      • Sofia, Bulgaria
        • Svetlozar H Haralanov Ph.D.
      • Sofia, Bulgaria
        • Vihra Milanova M.D.
      • Varna, Bulgaria
        • Georgi Popov M.D.
  • Croatia
      • Osijek, Croatia
        • Pavo Filakovic M.D./Ph.D.
      • Rijeka, Croatia
        • Ljiljana Moro M.D./Ph.D.
      • Split, Croatia
        • Goran Dodig M.D./Ph.D.
      • Zagreb, Croatia
        • Dubravka Kocijan-Hercigonja M.D.
      • Zagreb, Croatia
        • Miro Jakovljevic M.D.
      • Zagreb, Croatia
        • Vera Folnegovic-Smalc M.D/Ph.D
  • Romania
      • Bucharest, Romania
        • Mihai Dumitru Gheorge
      • Targu Mures, Romania
        • Aurel Nirestean M.D./Ph.D
  • Serbia
      • Belgrade, Serbia
        • Ivana Timotijevic M.D.
      • Belgrade, Serbia
        • Jelena Martinovic M.D.
      • Belgrade, Serbia
        • Vladimir Diligenski M.D.
      • Belgrade, Serbia
        • Vladimir Paunovic M.D.
      • Kragujevac, Serbia
        • Dragana Ignjatovic-Ristic M.D.
      • Novi Sad, Serbia
        • Ratomir Lisulov M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mifepristone
Drug: Mifepristone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corcept Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

August 8, 2005

First Submitted That Met QC Criteria

August 8, 2005

First Posted (Estimate)

August 10, 2005

Study Record Updates

Last Update Posted (Estimate)

February 15, 2012

Last Update Submitted That Met QC Criteria

February 14, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-1073-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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