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A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features

This study is currently recruiting participants.
Verified July 2013 by Corcept Therapeutics
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics
ClinicalTrials.gov Identifier:
NCT00637494
First received: March 11, 2008
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

Approximately 450 patients will be randomized to receive Mifepristone or placebo for 7 days followed by antidepressant. The purpose is to compare the efficacy of Mifepristone followed by antidepressant versus placebo followed by antidepressant in reducing psychotic symptoms in patients with a diagnosis of psychotic depression.


Condition Intervention Phase
Psychotic Depression
Major Depression With Psychotic Features
Psychosis
Drug: mifepristone
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Mifepristone vs. Placebo in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features

Resource links provided by NLM:


Further study details as provided by Corcept Therapeutics:

Primary Outcome Measures:
  • The proportion of Mifepristone versus placebo treated patients who achieve a score reduction from baseline on a standardized psychiatric rating scale. [ Time Frame: 56 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of Mifepristone treated patients with plasma drug concentrations above a specified amount versus placebo treated patients who achieve a score reduction from baseline on a standardized psychiatric rating scale. [ Time Frame: 56 days ] [ Designated as safety issue: No ]
  • The change in a standardized psychiatric rating scale score. [ Time Frame: 56 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: March 2008
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Mifepristone followed by an antidepressant
Drug: mifepristone
1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days
Other Name: Korlym
Placebo Comparator: 2
Placebo followed by an antidepressant
Drug: placebo
Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days
Other Name: control

Detailed Description:

Up to 450 patients with psychotic depression will be randomly assigned to receive either Mifepristone or matching placebo. Patients will be assessed by the Investigator or site staff during screening and on study days. A single antidepressant selected from a list of approved drugs will be administered after the administration of investigational drug. Adverse events, laboratory assessments, electrocardiograms, and physical examinations will be used to assess safety.

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have provided written consent to participate in the study prior to any study procedures and understand that they are free to withdraw from the study at any time. Patients must be able to read and understand the consent form, complete study-related procedures, and communicate with the study staff
  • Have a DSM-IV TR diagnosis of Major Depressive Disorder with Psychotic Features (DSM-IV 296.24 or 296.34), and are clinically symptomatic with their illness
  • Have pre-specified minimum scores on standardized psychiatric rating scales at baseline
  • Have not been taking excluded medication for at least 7 days prior to randomization
  • Have a negative pregnancy test
  • If not postmenopausal for ≥ 2 years or surgically sterile (6 months post-surgery), must consent (patient or partner) to utilize two medically acceptable methods of contraception, one of which is a barrier method, throughout the entire study period and for 3 months after the study is completed

Exclusion Criteria:

  • Have any primary psychiatric diagnosis other than psychotic depression.
  • Have a major medical problem, which in the opinion of the Investigator would place the patient at undue risk.
  • Have undergone electroconvulsive therapy within 3 months prior to randomization
  • Have had a hospitalization due to a suicide attempt within 45 days prior to randomization
  • Are female and of childbearing age, and are unable or unwilling to use two medically acceptable methods of contraception during the study and for three months after study completion, one of which must be a barrier method
  • Are female and are pregnant or lactating
  • Are currently taking excluded medications
  • Have used drugs of abuse within 30 days prior to screen, as per patient report and urine drug screen
  • Have a history of active drug or alcohol abuse within 3 months or dependence within 6 months prior to screening
  • Are in the opinion of the Investigator at immediate risk of suicide, or at risk of harming others
  • Have received investigational therapy (drug, vaccine, biological agent or device) within 6 months prior to randomization
  • Have previously participated in a clinical trial of Mifepristone (C-1073)
  • Have a history of an allergic reaction to Mifepristone (C-1073)
  • Are in the Investigator's opinion not appropriate for participation in the study or may not be capable of following the study schedule for any reason
  • Are patients who are employees of the study unit or their family members, students who are working in the study unit, or family members of the Investigator or Corcept Therapeutics.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637494

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Withdrawn
Birmingham, Alabama, United States, 35294
United States, Arizona
The University of Arizona Withdrawn
Tucson, Arizona, United States, 85724
United States, Arkansas
Woodland International Research Group, Inc. Terminated
Little Rock, Arkansas, United States, 72211
K&S Professional Research Services, LLC Recruiting
Little Rock, Arkansas, United States, 72201
Contact: Gregory S Kaczenski, MD    501-378-0400    gregory@kandsresearchservices.com   
Principal Investigator: Gregory S Kaczenski, MD         
United States, California
South Coast Clinical Trials, Inc Recruiting
Anaheim, California, United States, 92804
Contact: Ebtesam Khaled, MD    714-484-4904    khaled@southcoastclinicaltrials.com   
Principal Investigator: Ebtesam Khaled, MD         
NeuroNetwork Trials Withdrawn
Costa Mesa, California, United States, 92627
ATP Clinical Research, Inc. Withdrawn
Costa Mesa, California, United States, 92626
Diligent Clinical Trials Recruiting
Downey, California, United States, 90241
Contact: Elizabeth Zarate-Rowell, M.D.    562-622-0700      
Principal Investigator: Elizabeth Zarate-Rowell, M.D.         
Synergy Clinical Research Center Terminated
Escondido, California, United States, 92025
Collaborative Neuroscience Network, Inc. Recruiting
Garden Grove, California, United States, 92845
Contact: David Walling, PhD    714-799-7799      
Principal Investigator: David Walling, PhD         
Behavioral Research Specialists, LLC Withdrawn
Glendale, California, United States, 91204
Cedars-Sinai Medical Center Withdrawn
Los Angeles, California, United States, 90048
Pacific Research Partners Recruiting
Oakland, California, United States, 94612
Contact: Ira Glick, MD    510-444-2877      
Principal Investigator: Ira Glick, MD         
North County Clinical Research Terminated
Oceanside, California, United States, 92056
Breakthrough Clinical Trials Recruiting
San Bernardino, California, United States, 92408
Contact: Karen Frei, MD    909-882-7900    drfrei@brkthru.org   
Principal Investigator: Karen Frei, MD         
Sharp Mesa Vista Hospital Terminated
San Diego, California, United States, 92123
Cnri, Llc Terminated
San Diego, California, United States, 92126
Clinical Innovations, Inc. Withdrawn
Santa Ana, California, United States, 92705
United States, Colorado
Western Affiliated Research Institute Withdrawn
Denver, Colorado, United States, 80204
United States, Connecticut
Middlesex Hospital Withdrawn
Middletown, Connecticut, United States, 06457
United States, Florida
Professional Clinical Research, Inc. Terminated
Aventura, Florida, United States, 33180
University of Florida Terminated
Gainesville, Florida, United States, 32606
Segal Institute for Clinical Research Recruiting
Hollywood, Florida, United States, 33021
Contact: Segal    954-962-1355      
Principal Investigator: Scott Segal, MD         
Accurate Clinical Trials Terminated
Kissimmee, Florida, United States, 34741
AMB Research Center Recruiting
Miami, Florida, United States, 33144
Contact: Manuel Melendez, MD    305-646-1278    ambinvestigator@gmail.com   
Principal Investigator: Manuel Melendez, MD         
Lakeside Behavioral Health Recruiting
Orlando, Florida, United States, 32810
Contact: Richard D. Knapp, D.O.    407-644-1165    rknapp@flcrc.com   
Principal Investigator: Richard D. Knapp, D.O.         
University of South Florida Dept of Psychiatry and Neurosciences Recruiting
Tampa, Florida, United States, 33613
Contact: Jamie W Fernandez, M.D., M.S.    813-974-8142    jfernan1@health.usf.edu   
Principal Investigator: Jamie W Fernandez, M.D., M.S.         
United States, Georgia
Atlanta Center for Medical Research Recruiting
Atlanta, Georgia, United States, 30308
Contact: Robert Riesenberg, M.D.    404-881-5800      
Principal Investigator: Robert Riesenberg, MD         
United States, Illinois
Alexian Brothers Center for Psychiatric Research Terminated
Hoffman Estates, Illinois, United States, 60169
Rush Northshore Medical Center Withdrawn
Skokie, Illinois, United States, 60076
United States, Indiana
Indiana CTSI Withdrawn
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Mood and Anxiety Disorders Research Program Withdrawn
Cambridge, Massachusetts, United States, 02139
United States, Minnesota
University of Minnesota - Fairview Withdrawn
Minneapolis, Minnesota, United States, 55454
United States, Mississippi
Precise Research Centers Terminated
Flowood, Mississippi, United States, 39232
United States, Missouri
Millennium Psychiatric Associate Recruiting
Creve Coeur, Missouri, United States, 63141
Contact: Franco Sicuro, MD    314-298-0001    fsicuro@millenniumpa.com   
Principal Investigator: Franco Sicuro, MD         
St. Louis Clinical Trials Withdrawn
St. Louis, Missouri, United States, 63118
Scientella LLC Withdrawn
St. Louis, Missouri, United States, 63141
PsychCare Consultants Research Recruiting
St. Louis, Missouri, United States, 63128
Contact: Mohd A. Malik, MD    314-629-9356    pccresearch@aol.com   
Principal Investigator: Mohd A Malik, MD         
United States, New Jersey
CRI Lifetree Recruiting
Marlton, New Jersey, United States, 08053
Contact: Steven Glass, M.D.    866-549-3112      
Principal Investigator: Steven Glass, MD         
BioBehavioral Health Withdrawn
Toms River, New Jersey, United States, 08755
United States, New York
Neurobehavioral Research, Inc. Terminated
Cedarhurst, New York, United States, 11516
Advanced Bio-Behavioral Sciences, Inc Withdrawn
Elmsford, New York, United States, 10523
The Zucker Hillside Hospital Recruiting
Glen Oaks, New York, United States, 11004
Contact: Petrides, M.D.    718-470-8165      
Principal Investigator: Georgios Petrides, MD         
United States, North Carolina
Inquest Clinical Group/ Global Research Associates Recruiting
Hope Mills, North Carolina, United States, 28348
Contact: Antonio Cusi, MD    910-484-3148    icg@inquestclinicalgroup.com   
Principal Investigator: Antonio Cusi, MD         
Central Regional Hospital Withdrawn
Raleigh, North Carolina, United States, 27603
Wake Forest University Baptist Medical Center Terminated
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Rakesh Ranjan MD & Associates, Inc. Withdrawn
Beachwood, Ohio, United States, 44122
Psychiatric Professional Services, Inc. Withdrawn
Cincinnati, Ohio, United States, 45267
Midwest Clinical Research Center Recruiting
Dayton, Ohio, United States, 45417
Contact: Bernadette B D'Souza, MD    937-424-1050      
Principal Investigator: Bernadette B D'Souza, MD         
United States, Oklahoma
Oklahoma Clinical Research Center Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: M. Lane Peyton, MD    405-753-4994      
Principal Investigator: M. Lane Peyton, MD         
United States, Pennsylvania
Lehigh Center for Clinical Research Recruiting
Allentown, Pennsylvania, United States, 18104
Contact: Gross, M.D.    610-820-0342      
Contact    610-776-5157      
Principal Investigator: Paul Gross, MD         
CRI Worldwide, LLC Withdrawn
Philadelphia, Pennsylvania, United States, 19139
Belmont Center for Comprehensive Treatment Terminated
Philadelphia, Pennsylvania, United States, 19131
University of Pittsburgh Medical Center (UPMC) Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Robert Howland, MD    888-796-8226    howlandrh@upmc.edu   
Principal Investigator: Robert Howland, MD         
United States, South Carolina
Carolina Clinical Trials, Inc. Terminated
Charleston, South Carolina, United States, 29405
United States, Texas
Community Clinical Research Withdrawn
Austin, Texas, United States, 78754
FutureSearch Clinical Trials, L.P. Recruiting
Austin, Texas, United States, 78731
Contact: Donald J Garcia, MD    512-380-9595      
Principal Investigator: Donald J Garcia, MD         
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Mustafa Husain, MD    214-648-2806      
Principal Investigator: Mustafa Husain, MD         
Pillar Clinical Research, LLC Terminated
Dallas, Texas, United States, 75243
InSite Clinical Resesearch Recruiting
DeSoto, Texas, United States, 75115
Contact: Rajinder Shiwach, MD MRCP    972-283-6286    rshiwach@aol.com   
Principal Investigator: Raj Shiwach, MD         
InSite Clinical Research, LLC Recruiting
DeSoto, Texas, United States, 75115
Contact: Rajinder Shiwach, MD MRCP    972-283-6286    rshiwach@aol.com   
Principal Investigator: Rajinder Shiwach, MD MRCP         
Fein-Jennings Clinic, Inc. Terminated
Houston, Texas, United States, 77074
Claghorn-Lesem Research Clinic Recruiting
Houston, Texas, United States, 77008
Contact: Michael Lesem, MD    713-965-7900      
Principal Investigator: Michael Lesem, MD         
Clinical Trial Network Recruiting
Houston, Texas, United States, 77074
Contact: Jorge Raichman, MD    713-484-6947      
Principal Investigator: Jorge Raichman, MD         
Alamo Superior Research Withdrawn
San Antonio, Texas, United States, 78229
United States, Utah
Clark Johnson, MD Withdrawn
Salt Lake City, Utah, United States, 84107
Lifetree Clinical Research Recruiting
Salt Lake City, Utah, United States, 84106
Contact: Clark Johnson, M.D.    801-269-8200      
Principal Investigator: Clark Johnson, M.D.         
United States, Virginia
Alliance Research Group Withdrawn
Richmond, Virginia, United States, 23230
United States, Washington
Eastside Therapeutic Resource Withdrawn
Kirkland, Washington, United States, 98033
Scientella, LLC. Withdrawn
Richland, Washington, United States, 99352
Sponsors and Collaborators
Corcept Therapeutics
Investigators
Study Director: Thaddeus Block, MD Corcept Therapeutics
  More Information

Additional Information:
Publications:
Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT00637494     History of Changes
Other Study ID Numbers: C-1073-14
Study First Received: March 11, 2008
Last Updated: July 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Corcept Therapeutics:
psychotic depression
major depression with psychotic features
psychosis

Additional relevant MeSH terms:
Depression
Depressive Disorder
Mental Disorders
Psychotic Disorders
Depressive Disorder, Major
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Affective Disorders, Psychotic
Mifepristone
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on April 15, 2014