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

NCT ID: NCT00637494

Last Updated: 2017-06-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2014-06-30

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.

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.

Conditions

Psychotic Depression; Severe Major Depression With Psychotic Features; Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Mifepristone followed by an antidepressant

Group Type: ACTIVE_COMPARATOR

mifepristone

Intervention Type: DRUG

1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days

2

Placebo followed by an antidepressant

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days

Interventions

mifepristone

1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days

Intervention Type: DRUG

placebo

Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days

Intervention Type: DRUG

Other Intervention Names

Korlym; control

Eligibility 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
• 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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corcept Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thaddeus Block, MD

Role: STUDY_DIRECTOR

Corcept Therapeutics

Locations

K&S Professional Research Services, LLC

Little Rock, Arkansas, United States

Woodland International Research Group, Inc.

Little Rock, Arkansas, United States

South Coast Clinical Trials, Inc

Anaheim, California, United States

Diligent Clinical Trials

Downey, California, United States

Synergy Clinical Research Center

Escondido, California, United States

Collaborative Neuroscience Network, Inc.

Garden Grove, California, United States

Pacific Research Partners

Oakland, California, United States

North County Clinical Research

Oceanside, California, United States

Breakthrough Clinical Trials

San Bernardino, California, United States

Sharp Mesa Vista Hospital

San Diego, California, United States

Cnri, Llc

San Diego, California, United States

Professional Clinical Research, Inc.

Aventura, Florida, United States

University of Florida

Gainesville, Florida, United States

Segal Institute for Clinical Research

Hollywood, Florida, United States

Accurate Clinical Trials

Kissimmee, Florida, United States

AMB Research Center

Miami, Florida, United States

Lakeside Behavioral Health

Orlando, Florida, United States

University of South Florida Dept of Psychiatry and Neurosciences

Tampa, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Alexian Brothers Center for Psychiatric Research

Hoffman Estates, Illinois, United States

Precise Research Centers

Flowood, Mississippi, United States

Millennium Psychiatric Associate

Creve Coeur, Missouri, United States

PsychCare Consultants Research

St Louis, Missouri, United States

CRI Lifetree

Marlton, New Jersey, United States

Neurobehavioral Research, Inc.

Cedarhurst, New York, United States

The Zucker Hillside Hospital

Glen Oaks, New York, United States

Inquest Clinical Group/ Global Research Associates

Hope Mills, North Carolina, United States

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Midwest Clinical Research Center

Dayton, Ohio, United States

Oklahoma Clinical Research Center

Oklahoma City, Oklahoma, United States

Lehigh Center for Clinical Research

Allentown, Pennsylvania, United States

Belmont Center for Comprehensive Treatment

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, United States

Carolina Clinical Trials, Inc.

Charleston, South Carolina, United States

FutureSearch Clinical Trials, L.P.

Austin, Texas, United States

Pillar Clinical Research, LLC

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

InSite Clinical Research, LLC

DeSoto, Texas, United States

Claghorn-Lesem Research Clinic

Houston, Texas, United States

Clinical Trial Network

Houston, Texas, United States

Fein-Jennings Clinic, Inc.

Houston, Texas, United States

Lifetree Clinical Research

Salt Lake City, Utah, United States

Countries

United States

References

DeBattista C, Belanoff J, Glass S, Khan A, Horne RL, Blasey C, Carpenter LL, Alva G. Mifepristone versus placebo in the treatment of psychosis in patients with psychotic major depression. Biol Psychiatry. 2006 Dec 15;60(12):1343-9. doi: 10.1016/j.biopsych.2006.05.034. Epub 2006 Aug 4.

Reference Type: BACKGROUND

PMID: 16889757 (View on PubMed)

Flores BH, Kenna H, Keller J, Solvason HB, Schatzberg AF. Clinical and biological effects of mifepristone treatment for psychotic depression. Neuropsychopharmacology. 2006 Mar;31(3):628-36. doi: 10.1038/sj.npp.1300884.

Reference Type: BACKGROUND

PMID: 16160710 (View on PubMed)

Belanoff JK, Rothschild AJ, Cassidy F, DeBattista C, Baulieu EE, Schold C, Schatzberg AF. An open label trial of C-1073 (mifepristone) for psychotic major depression. Biol Psychiatry. 2002 Sep 1;52(5):386-92. doi: 10.1016/s0006-3223(02)01432-4.

Reference Type: BACKGROUND

PMID: 12242054 (View on PubMed)

Belanoff JK, Flores BH, Kalezhan M, Sund B, Schatzberg AF. Rapid reversal of psychotic depression using mifepristone. J Clin Psychopharmacol. 2001 Oct;21(5):516-21. doi: 10.1097/00004714-200110000-00009.

Reference Type: BACKGROUND

PMID: 11593077 (View on PubMed)

Block TS, Kushner H, Kalin N, Nelson C, Belanoff J, Schatzberg A. Combined Analysis of Mifepristone for Psychotic Depression: Plasma Levels Associated With Clinical Response. Biol Psychiatry. 2018 Jul 1;84(1):46-54. doi: 10.1016/j.biopsych.2018.01.008. Epub 2018 Jan 31.

Reference Type: DERIVED

PMID: 29523415 (View on PubMed)

Related Links

http://www.corcept.com

Corcept Therapeutics

Other Identifiers

C-1073-14

Identifier Type: -

Identifier Source: org_study_id