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



Status:Terminated
Conditions:Depression, Major Depression Disorder (MDD), Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:22 - Any
Updated:4/21/2016
Start Date:March 2008
End Date:June 2014

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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

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.

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.

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 (C-1073)

- Have a history of an allergic reaction to Mifepristone (C-1073)

- 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.
We found this trial at
43
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Little Rock, Arkansas 72211
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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3838 South 700 East
Salt Lake City, Utah 84106
801-269-8200
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Allentown, Pennsylvania 18104
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Anaheim, California 92804
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Austin, Texas 78756
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Aventura, Florida 33180
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Cedarhurst, New York 11516
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Charleston, South Carolina 29405
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Creve Coeur, Missouri 63141
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dallas, Texas 75243
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DeSoto, Texas 75115
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DeSoto, Texas 75115
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Downey, California 90241
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Escondido, California 92025
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Flowood, Mississippi 39232
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Garden Grove, California 92845
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Glen Oaks, New York 11004
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Hoffman Estates, Illinois 60169
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Hollywood, Florida 33021
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Hope Mills, North Carolina 28348
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Houston, Texas 77074
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Houston, Texas 77008
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Houston, Texas 77074
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Kissimmee, Florida 34741
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Little Rock, Arkansas 72201
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Marlton, New Jersey 08053
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Miami, Florida 33144
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Oakland, California 94612
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Oceanside, California 92056
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Oklahoma City, Oklahoma 73112
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Orlando, Florida 32810
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Philadelphia, Pennsylvania 19131
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Pittsburgh, Pennsylvania 15213
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San Bernardino, California 92408
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San Diego, California 92123
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San Diego, California 92126
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St. Louis, Missouri 63128
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Baptist Medical Center Welcome to Wake Forest Baptist Medical Center, a fully...
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