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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00637494
Recruitment Status : Terminated (DRC recommended stopping study as it had missed its primary endpoint)
First Posted : March 18, 2008
Results First Posted : February 16, 2017
Last Update Posted : June 5, 2017
Information provided by (Responsible Party):
Corcept Therapeutics

Brief Summary:
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 or disease Intervention/treatment Phase
Psychotic Depression Severe Major Depression With Psychotic Features Psychosis Drug: mifepristone Drug: placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2008
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Proportion of Mifepristone vs. Placebo Treated Patients With at Least a 50% Reduction From Baseline in Brief Psychiatric Rating Scale-Positive Symptom Subscale (BPRS-PSS) at Days 7 and 56 [ Time Frame: 56 days ]
    Response as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group administered mifepristone

Secondary Outcome Measures :
  1. Proportion of Mifepristone Treated Patients With Plasma Drug Concentrations Equal to or Above 1637 ng/mL vs. Placebo Treated Patients Who Achieve a ≤ 50% Reduction in BPRS-PSS at Days 7 and 56 [ Time Frame: 56 days ]
    Response as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group who achieved a sufficiently high plasma level of mifepristone

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • Have a history of an allergic reaction to mifepristone
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00637494

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United States, Arkansas
K&S Professional Research Services, LLC
Little Rock, Arkansas, United States, 72201
Woodland International Research Group, Inc.
Little Rock, Arkansas, United States, 72211
United States, California
South Coast Clinical Trials, Inc
Anaheim, California, United States, 92804
Diligent Clinical Trials
Downey, California, United States, 90241
Synergy Clinical Research Center
Escondido, California, United States, 92025
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States, 92845
Pacific Research Partners
Oakland, California, United States, 94612
North County Clinical Research
Oceanside, California, United States, 92056
Breakthrough Clinical Trials
San Bernardino, California, United States, 92408
Sharp Mesa Vista Hospital
San Diego, California, United States, 92123
Cnri, Llc
San Diego, California, United States, 92126
United States, Florida
Professional Clinical Research, Inc.
Aventura, Florida, United States, 33180
University of Florida
Gainesville, Florida, United States, 32606
Segal Institute for Clinical Research
Hollywood, Florida, United States, 33021
Accurate Clinical Trials
Kissimmee, Florida, United States, 34741
AMB Research Center
Miami, Florida, United States, 33144
Lakeside Behavioral Health
Orlando, Florida, United States, 32810
University of South Florida Dept of Psychiatry and Neurosciences
Tampa, Florida, United States, 33613
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
United States, Illinois
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States, 60169
United States, Mississippi
Precise Research Centers
Flowood, Mississippi, United States, 39232
United States, Missouri
Millennium Psychiatric Associate
Creve Coeur, Missouri, United States, 63141
PsychCare Consultants Research
Saint Louis, Missouri, United States, 63128
United States, New Jersey
CRI Lifetree
Marlton, New Jersey, United States, 08053
United States, New York
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States, 11516
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
United States, North Carolina
Inquest Clinical Group/ Global Research Associates
Hope Mills, North Carolina, United States, 28348
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Midwest Clinical Research Center
Dayton, Ohio, United States, 45417
United States, Oklahoma
Oklahoma Clinical Research Center
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States, 18104
Belmont Center for Comprehensive Treatment
Philadelphia, Pennsylvania, United States, 19131
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Carolina Clinical Trials, Inc.
Charleston, South Carolina, United States, 29405
United States, Texas
FutureSearch Clinical Trials, L.P.
Austin, Texas, United States, 78731
Pillar Clinical Research, LLC
Dallas, Texas, United States, 75243
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
InSite Clinical Research, LLC
DeSoto, Texas, United States, 75115
Claghorn-Lesem Research Clinic
Houston, Texas, United States, 77008
Clinical Trial Network
Houston, Texas, United States, 77074
Fein-Jennings Clinic, Inc.
Houston, Texas, United States, 77074
United States, Utah
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Corcept Therapeutics
Study Director: Thaddeus Block, MD Corcept Therapeutics

Additional Information:
Responsible Party: Corcept Therapeutics Identifier: NCT00637494     History of Changes
Other Study ID Numbers: C-1073-14
First Posted: March 18, 2008    Key Record Dates
Results First Posted: February 16, 2017
Last Update Posted: June 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Depressive Disorder
Psychotic Disorders
Mental Disorders
Depressive Disorder, Major
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents