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

Phase 3

Terminated

Conditions: Psychotic Depression
Severe Major Depression With Psychotic Features
Psychosis

Interventions: Drug: mifepristone
Drug: placebo

Registration Number: NCT00637494

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 292

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	mifepristone	Mifepristone followed by an antidepressant
2	placebo	Placebo followed by an antidepressant

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
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	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

Trial Locations

Locations (42): Inquest Clinical Group/ Global Research Associates
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Hope Mills, North Carolina, United States
Collaborative Neuroscience Network, Inc.
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Garden Grove, California, United States
Breakthrough Clinical Trials
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San Bernardino, California, United States
Alexian Brothers Center for Psychiatric Research
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Hoffman Estates, Illinois, United States
CRI Lifetree
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Marlton, New Jersey, United States
InSite Clinical Research, LLC
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DeSoto, Texas, United States
Midwest Clinical Research Center
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Dayton, Ohio, United States
Millennium Psychiatric Associate
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Creve Coeur, Missouri, United States
FutureSearch Clinical Trials, L.P.
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Austin, Texas, United States
North County Clinical Research
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Oceanside, California, United States
PsychCare Consultants Research
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Saint Louis, Missouri, United States
Neurobehavioral Research, Inc.
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Cedarhurst, New York, United States
K&S Professional Research Services, LLC
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Little Rock, Arkansas, United States
Diligent Clinical Trials
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Downey, California, United States
Pacific Research Partners
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Oakland, California, United States
Woodland International Research Group, Inc.
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Little Rock, Arkansas, United States
Synergy Clinical Research Center
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Escondido, California, United States
Precise Research Centers
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Flowood, Mississippi, United States
The Zucker Hillside Hospital
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Glen Oaks, New York, United States
University of Florida
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Gainesville, Florida, United States
South Coast Clinical Trials, Inc
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Anaheim, California, United States
Sharp Mesa Vista Hospital
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San Diego, California, United States
Cnri, Llc
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San Diego, California, United States
Professional Clinical Research, Inc.
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Aventura, Florida, United States
Segal Institute for Clinical Research
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Hollywood, Florida, United States
University of South Florida Dept of Psychiatry and Neurosciences
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Tampa, Florida, United States
Accurate Clinical Trials
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Kissimmee, Florida, United States
AMB Research Center
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Miami, Florida, United States
Lakeside Behavioral Health
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Orlando, Florida, United States
Wake Forest University Baptist Medical Center
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Winston-Salem, North Carolina, United States
Oklahoma Clinical Research Center
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Oklahoma City, Oklahoma, United States
Lehigh Center for Clinical Research
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Allentown, Pennsylvania, United States
Belmont Center for Comprehensive Treatment
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Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC)
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Pittsburgh, Pennsylvania, United States
Atlanta Center for Medical Research
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Atlanta, Georgia, United States
Carolina Clinical Trials, Inc.
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Charleston, South Carolina, United States
Pillar Clinical Research, LLC
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Dallas, Texas, United States
University of Texas Southwestern Medical Center
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Dallas, Texas, United States
Claghorn-Lesem Research Clinic
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Houston, Texas, United States
Clinical Trial Network
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Houston, Texas, United States
Fein-Jennings Clinic, Inc.
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Houston, Texas, United States
Lifetree Clinical Research
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Salt Lake City, Utah, United States