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

This study is currently recruiting participants.
Verified July 2013 by Corcept Therapeutics
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics
ClinicalTrials.gov Identifier:
NCT00637494
First received: March 11, 2008
Last updated: July 31, 2013
Last verified: July 2013

March 11, 2008
July 31, 2013
March 2008
March 2014   (final data collection date for primary outcome measure)
The proportion of Mifepristone versus placebo treated patients who achieve a score reduction from baseline on a standardized psychiatric rating scale. [ Time Frame: 56 days ] [ Designated as safety issue: No ]
The proportion of CORLUX™ versus placebo treated patients who achieve a score reduction from baseline on a standardized psychiatric rating scale. [ Time Frame: 56 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00637494 on ClinicalTrials.gov Archive Site
  • 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. [ Time Frame: 56 days ] [ Designated as safety issue: No ]
  • The change in a standardized psychiatric rating scale score. [ Time Frame: 56 days ] [ Designated as safety issue: No ]
  • The proportion of CORLUX™ 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. [ Time Frame: 56 days ] [ Designated as safety issue: No ]
  • The change in a standardized psychiatric rating scale score. [ Time Frame: 56 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Psychotic Depression
  • Major Depression With Psychotic Features
  • Psychosis
  • Drug: mifepristone
    1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days
    Other Name: Korlym
  • Drug: placebo
    Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days
    Other Name: control
  • Active Comparator: 1
    Mifepristone followed by an antidepressant
    Intervention: Drug: mifepristone
  • Placebo Comparator: 2
    Placebo followed by an antidepressant
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
March 2014
March 2014   (final data collection date for primary outcome measure)

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.
Both
22 Years and older
No
Not Provided
United States
 
NCT00637494
C-1073-14
No
Corcept Therapeutics
Corcept Therapeutics
Not Provided
Study Director: Thaddeus Block, MD Corcept Therapeutics
Corcept Therapeutics
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP