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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 by Corcept Therapeutics, December 2008
Sponsored by: Corcept Therapeutics
Information provided by: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT00637494
  Purpose

Approximately 450 patients will be randomized to receive CORLUX™ (Mifepristone) or placebo for 7 days followed by antidepressant. The purpose is to compare the efficacy of CORLUX followed by antidepressant versus placebo followed by antidepressant in reducing psychotic symptoms in patients with a diagnosis of psychotic depression.


Condition Intervention Phase
Psychotic Depression
Major Depression With Psychotic Features
Psychosis
Drug: mifepristone
Drug: placebo
Phase III

MedlinePlus related topics: Depression Psychotic Disorders
Drug Information available for: Mifepristone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of CORLUX (Mifepristone) vs. Placebo in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features

Further study details as provided by Corcept Therapeutics:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 450
Study Start Date: March 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
CORLUX (mifepristone) followed by an antidepressant
Drug: mifepristone
1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days
2: Placebo Comparator
Placebo followed by an antidepressant
Drug: placebo
Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days

Detailed Description:

Up to 450 patients with psychotic depression will be randomly assigned to receive either CORLUX 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

Ages Eligible for Study:   22 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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 had ongoing psychosis with no significant remission for 2 years or longer
  • 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 CORLUX (C-1073, mifepristone)
  • Have a history of an allergic reaction to CORLUX (C-1073, 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637494

Contacts
Contact: Thaddeus Block, MD 650-327-3270 tblock@corcept.com
Contact: Janet Diehl, BS 650-327-3270

  Show 39 Study Locations
Sponsors and Collaborators
Corcept Therapeutics
Investigators
Study Director: Thaddeus Block, MD Corcept Therapeutics
  More Information

Corcept Therapeutics  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Corcept Therapeutics ( Thaddeus Block, M.D., Medical Director )
Study ID Numbers: C-1073-14
Study First Received: March 11, 2008
Last Updated: December 17, 2008
ClinicalTrials.gov Identifier: NCT00637494  
Health Authority: United States: Food and Drug Administration

Keywords provided by Corcept Therapeutics:
psychotic depression
major depression with psychotic features
psychosis

Study placed in the following topic categories:
Schizophrenia
Affective Disorders, Psychotic
Depression
Mental Disorders
Bipolar Disorder
Mood Disorders
Mifepristone
Psychotic Disorders
Depressive Disorder, Major
Depressive Disorder
Schizophrenia and Disorders with Psychotic Features
Behavioral Symptoms

Additional relevant MeSH terms:
Abortifacient Agents, Steroidal
Contraceptives, Postcoital, Synthetic
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Contraceptives, Postcoital
Luteolytic Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Menstruation-Inducing Agents
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on January 16, 2009