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

Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00637494
• Other study ID #: C-1073-14
• Status: Terminated
• Phase: Phase 3
• First received: March 11, 2008
• Last updated: April 22, 2016
• Start date: March 2008
• Est. completion date: June 2014

Study information

• Verified date: April 2016
• Source: Corcept Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 292
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Mental Disorders
• Psychosis
• Psychotic Depression
• Psychotic Disorders
• Severe Major Depression With Psychotic Features

Intervention

Drug:
• mifepristone
1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days
• placebo
Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Epub 2006 Aug 4. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of Mifepristone versus placebo treated patients who achieve a score reduction from baseline on a standardized psychiatric rating scale.		56 days	No
Secondary	The proportion of Mifepristone treated patients with plasma drug concentrations above a specified amount versus placebo treated patients who achieve a score reduction from baseline on a standardized psychiatric rating scale.		56 days	No
Secondary	The change in a standardized psychiatric rating scale score.		56 days	No

External Links

•   Corcept Therapeutics