An International Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression

February 14, 2012 updated by: Corcept Therapeutics

An International, Double-Blind, Placebo-Controlled, Study of the Efficacy and Safety of CORLUX™ (Mifepristone) vs. Placebo in the Treatment of Psychotic Symptoms in Patients With Psychotic Major Depression (PMD)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

247

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.
  • Former Serbia and Montenegro
      • Belgrade, Former Serbia and Montenegro
        • Ivana Timotijevic M.D.
      • Belgrade, Former Serbia and Montenegro
        • Jelena Martinovic M.D.
      • Belgrade, Former Serbia and Montenegro
        • Vladimir Diligenski M.D.
      • Belgrade, Former Serbia and Montenegro
        • Vladimir Paunovic M.D.
      • Kragujevac, Former Serbia and Montenegro
        • Dragana Ignjatovic-Ristic M.D.
      • Novi Sad, Former Serbia and Montenegro
        • Ratomir Lisulov M.D.
  • Romania
      • Bucharest, Romania
        • Mihai Dumitru Gheorge
      • Targu Mures, Romania
        • Aurel Nirestean M.D./Ph.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:

  • Are 18 to 75 years of age
  • Have a diagnosis of major depressive disorder with psychotic features (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM IV] 296.24 or 296.34)
  • Are able to provide written informed consent.

Exclusion Criteria:

  • 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 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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: mifepristone 600 mg
Drug: Mifepristone
PLACEBO_COMPARATOR: matching placebo
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change in a measure of psychosis
Time Frame: screening and on Days 0, 7, 14, 28, 42, and 56
screening and on Days 0, 7, 14, 28, 42, and 56

Secondary Outcome Measures

Outcome Measure
Time Frame
The change in a measure of depression
Time Frame: screening and on Days 0, 7, 14, 28, 42, and 56
screening and on Days 0, 7, 14, 28, 42, and 56

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

May 1, 2005

Primary Completion (ACTUAL)

July 1, 2006

Study Completion (ACTUAL)

July 1, 2006

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (ESTIMATE)

September 7, 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-1073-09

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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