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

NCT00637494 | Terminated Phase 3 Results DMC

• 1 other identifier: C-1073-14
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 42

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.

Conditions

Psychotic Depression; Severe Major Depression With Psychotic Features; Psychosis

Keywords

psychotic depression; major depression with psychotic features; psychosis

Outcome Measures

Primary Outcomes (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

  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

  56 days

Secondary Outcomes (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

  56 days

Study Arms (2)

1

ACTIVE COMPARATOR

Mifepristone followed by an antidepressant

Drug: mifepristone

2

PLACEBO COMPARATOR

Placebo followed by an antidepressant

Drug: placebo

Interventions

mifepristone DRUG

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

Also known as: Korlym

1

placebo DRUG

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

Also known as: control

2

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (42)

K&S Professional Research Services, LLC

Little Rock, Arkansas, 72201, United States

Location

Woodland International Research Group, Inc.

Little Rock, Arkansas, 72211, United States

Location

South Coast Clinical Trials, Inc

Anaheim, California, 92804, United States

Location

Diligent Clinical Trials

Downey, California, 90241, United States

Location

Synergy Clinical Research Center

Escondido, California, 92025, United States

Location

Collaborative Neuroscience Network, Inc.

Garden Grove, California, 92845, United States

Location

Pacific Research Partners

Oakland, California, 94612, United States

Location

North County Clinical Research

Oceanside, California, 92056, United States

Location

Breakthrough Clinical Trials

San Bernardino, California, 92408, United States

Location

Sharp Mesa Vista Hospital

San Diego, California, 92123, United States

Location

Cnri, Llc

San Diego, California, 92126, United States

Location

Professional Clinical Research, Inc.

Aventura, Florida, 33180, United States

Location

University of Florida

Gainesville, Florida, 32606, United States

Location

Segal Institute for Clinical Research

Hollywood, Florida, 33021, United States

Location

Accurate Clinical Trials

Kissimmee, Florida, 34741, United States

Location

AMB Research Center

Miami, Florida, 33144, United States

Location

Lakeside Behavioral Health

Orlando, Florida, 32810, United States

Location

University of South Florida Dept of Psychiatry and Neurosciences

Tampa, Florida, 33613, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

Alexian Brothers Center for Psychiatric Research

Hoffman Estates, Illinois, 60169, United States

Location

Precise Research Centers

Flowood, Mississippi, 39232, United States

Location

Millennium Psychiatric Associate

Creve Coeur, Missouri, 63141, United States

Location

PsychCare Consultants Research

St Louis, Missouri, 63128, United States

Location

CRI Lifetree

Marlton, New Jersey, 08053, United States

Location

Neurobehavioral Research, Inc.

Cedarhurst, New York, 11516, United States

Location

The Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

Inquest Clinical Group/ Global Research Associates

Hope Mills, North Carolina, 28348, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Oklahoma Clinical Research Center

Oklahoma City, Oklahoma, 73112, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

Belmont Center for Comprehensive Treatment

Philadelphia, Pennsylvania, 19131, United States

Location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

Location

Carolina Clinical Trials, Inc.

Charleston, South Carolina, 29405, United States

Location

FutureSearch Clinical Trials, L.P.

Austin, Texas, 78731, United States

Location

Pillar Clinical Research, LLC

Dallas, Texas, 75243, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

InSite Clinical Research, LLC

DeSoto, Texas, 75115, United States

Location

Claghorn-Lesem Research Clinic

Houston, Texas, 77008, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Fein-Jennings Clinic, Inc.

Houston, Texas, 77074, United States

Location

Lifetree Clinical Research

Salt Lake City, Utah, 84106, United States

Location

Related Publications (5)

• 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.

  PMID: 16889757 BACKGROUND

• 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.

  PMID: 16160710 BACKGROUND

• 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.

  PMID: 12242054 BACKGROUND

• 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.

  PMID: 11593077 BACKGROUND

• 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.

  PMID: 29523415 DERIVED

Related Links

• Corcept Therapeutics

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Thaddeus S. Block, MD
• Organization: Corcept Therapeutics

tblock@corcept.com

(650) 688-8816

Study Officials

• Thaddeus Block, MD

  Corcept Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 18, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 5, 2017
• Results First Posted: February 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (42)