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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Psychotic Depression, Severe Major Depression With Psychotic Features, Psychosis

In brief

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.

Key facts

Study ID

NCT00637494

Run by

Corcept Therapeutics

People needed

292

Starts

2008-03-01

Expected to finish

2014-06-01

Last updated by the study team

2017-06-05

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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