A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features
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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 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 CORLUX (Mifepristone) vs. Placebo in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features |
- 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 ]
- 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: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
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
Other Name: CORLUX
|
|
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 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 |
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 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
Show 63 Study Locations| 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: | April 30, 2013 |
| 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:
|
Depression Depressive Disorder Mental Disorders Psychotic Disorders Depressive Disorder, Major Bipolar Disorder Behavioral Symptoms Mood Disorders Schizophrenia and Disorders with Psychotic Features Affective Disorders, Psychotic Mifepristone Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female |
Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptives, Postcoital, Synthetic Contraceptives, Postcoital Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Luteolytic Agents Menstruation-Inducing Agents Abortifacient Agents, Steroidal Abortifacient Agents |
ClinicalTrials.gov processed this record on May 16, 2013