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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics
ClinicalTrials.gov Identifier:
NCT00637494
First received: March 11, 2008
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Psychotic Depression
Major Depression With Psychotic Features
Psychosis
Drug: mifepristone
Drug: placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Corcept Therapeutics:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 450
Study Start Date: March 2008
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Other Name: Korlym
Placebo Comparator: 2
Placebo followed by an antidepressant
Drug: placebo
Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days
Other Name: control

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

Ages Eligible for Study:   22 Years and older
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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637494

  Show 43 Study Locations
Sponsors and Collaborators
Corcept Therapeutics
Investigators
Study Director: Thaddeus Block, MD Corcept Therapeutics
  More Information

Additional Information:
Publications:
Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT00637494     History of Changes
Other Study ID Numbers: C-1073-14
Study First Received: March 11, 2008
Last Updated: July 1, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Depressive Disorder, Major
Mental Disorders
Psychotic Disorders
Affective Disorders, Psychotic
Behavioral Symptoms
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Mifepristone
Abortifacient Agents
Abortifacient Agents, Steroidal
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital
Contraceptives, Postcoital, Synthetic
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014