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

February 14, 2012 updated by: Corcept Therapeutics

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

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)

257

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

  • United States
    • California
      • Pico Rivera, California, United States, 90660
        • CNRI-LA
      • Riverside, California, United States, 92506
        • Behavioral Health 2000, LLC
      • San Diego, California, United States, 92126
        • Cnri, Llc
    • Florida
      • Jacksonville, Florida, United States, 32257
        • University of Florida Clinical Trials
      • Pompano Beach, Florida, United States, 33064
        • Quantum Laboratories/Memory Disorder Center
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Center for Medical Research
    • Illinois
      • Oak Brook, Illinois, United States, 60523
        • American Medical Research, Inc.
    • Indiana
      • Greenwood, Indiana, United States, 46143
        • Valle Vista Health System
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Psychopharmacology Research
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Robert Horne, MD
    • New Jersey
      • Clementon, New Jersey, United States, 08021
        • CNS Research Institute
      • Newark, New Jersey, United States, 07101
        • NMDNJ
      • Toms River, New Jersey, United States, 08755
        • Bio Behavioral Health
    • New York
      • Glen Oaks, New York, United States, 11004
        • Zucker Hillside Hospital
      • Lawrence, New York, United States, 11559
        • Neurobehavioral Research Company
    • Ohio
      • Dayton, Ohio, United States, 45408
        • Midwest Clinical Research Center
      • Lyndhurst, Ohio, United States, 44124
        • Rakesh Ranjan, MD and Associates, Inc
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73101
        • IPS Research Company
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19149
        • CNS Research Institute
    • Texas
      • Bellaire, Texas, United States, 77401
        • Claghorn-Lesem Research Clinic
      • Wichita Falls, Texas, United States, 76309
        • Grayline Clinical Drug Trials
    • Virginia
      • Richmond, Virginia, United States, 23229
        • International Clinical Research Associates
    • Washington
      • Bellevue, Washington, United States, 98004
        • Northwest Clinical Research Center

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:

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 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
daily for 7 days
PLACEBO_COMPARATOR: matching placebo
Drug: matching placebo
daily for 7 days

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

September 1, 2004

Primary Completion (ACTUAL)

June 1, 2006

Study Completion (ACTUAL)

June 1, 2006

Study Registration Dates

First Submitted

August 12, 2005

First Submitted That Met QC Criteria

August 12, 2005

First Posted (ESTIMATE)

August 16, 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-1073-07

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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