Clinical trial NCT00637494: A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Psychotic Depression
Severe Major Depression With Psychotic Features
Psychosis
Keywords: psychotic depression
major depression with psychotic features
psychosis
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-03-18
Enrollment: 292
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 56 days
Secondary outcomes:
measure: 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
timeFrame: 56 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: K&S Professional Research Services, LLC
state: Arkansas
city: Little Rock
country: United States
facility: Woodland International Research Group, Inc.
state: Arkansas
city: Anaheim
country: United States
facility: South Coast Clinical Trials, Inc
state: California
city: Downey
country: United States
facility: Diligent Clinical Trials
state: California
city: Escondido
country: United States
facility: Synergy Clinical Research Center
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: Oakland
country: United States
facility: Pacific Research Partners
state: California
city: Oceanside
country: United States
facility: North County Clinical Research
state: California
city: San Bernardino
country: United States
facility: Breakthrough Clinical Trials
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: San Diego
country: United States
facility: Cnri, Llc
state: California
city: Aventura
country: United States
facility: Professional Clinical Research, Inc.
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Hollywood
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Kissimmee
country: United States
facility: Accurate Clinical Trials
state: Florida
city: Miami
country: United States
facility: AMB Research Center
state: Florida
city: Orlando
country: United States
facility: Lakeside Behavioral Health
state: Florida
city: Tampa
country: United States
facility: University of South Florida Dept of Psychiatry and Neurosciences
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Hoffman Estates
country: United States
facility: Alexian Brothers Center for Psychiatric Research
state: Illinois
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Creve Coeur
country: United States
facility: Millennium Psychiatric Associate
state: Missouri
city: Saint Louis
country: United States
facility: PsychCare Consultants Research
state: Missouri
city: Marlton
country: United States
facility: CRI Lifetree
state: New Jersey
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: Glen Oaks
country: United States
facility: The Zucker Hillside Hospital
state: New York
city: Hope Mills
country: United States
facility: Inquest Clinical Group/ Global Research Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Clinical Research Center
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Belmont Center for Comprehensive Treatment
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC)
state: Pennsylvania
city: Charleston
country: United States
facility: Carolina Clinical Trials, Inc.
state: South Carolina
city: Austin
country: United States
facility: FutureSearch Clinical Trials, L.P.
state: Texas
city: Dallas
country: United States
facility: Pillar Clinical Research, LLC
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research, LLC
state: Texas
city: Houston
country: United States
facility: Claghorn-Lesem Research Clinic
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Houston
country: United States
facility: Fein-Jennings Clinic, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
Study officials:
affiliation: Corcept Therapeutics
name: Thaddeus Block, MD
role: STUDY_DIRECTOR
References:
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. doi: 10.1016/j.biopsych.2006.05.034. Epub 2006 Aug 4.
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. doi: 10.1038/sj.npp.1300884.
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. doi: 10.1016/s0006-3223(02)01432-4.
citation: 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.
citation: 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.