A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Efficacy of Three Dose Levels of CORLUX™ (Mifepristone) Plus an Antidepressant vs. Placebo Plus an Antidepressant in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features (PMD)

Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol. Under normal conditions, cortisol and other hormones are created by the body in response to physical and emotional stress, triggering a healthy stress response. People who suffer from psychotic major depression may have unusually high levels of cortisol circulating within them or abnormal patterns of cortisol levels, overloading the stress response mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If Corlux can keep the body's cortisol receptors from being overloaded, the stress response system may return to normal function, which may result in improvement of symptoms. The purpose of this 56 day study is to learn the safety and effectiveness of Corlux in patients who have been diagnosed with psychotic major depression (PMD).

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders; Major Depressive Disorder
• Intervention / Treatment: Drug: mifepristone; Drug: mifepristone matched placebo; Drug: mifepristone 600 mg; Drug: mifepristone 1200 mg

• Study Type: Interventional
• Enrollment (Actual): 443
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72201
      • K&S Research Services
  • California
    • Cerritos, California, United States, 90703
      • Center for Emotional Fitness
    • Fountain Valley, California, United States, 92708
      • Harbor Medical Associates, Inc.
    • National City, California, United States, 91950
      • Synergy Clinical Research Center
    • Oceanside, California, United States, 92056
      • Excell Research
    • Riverside, California, United States, 92506
      • Pacific Clinical Research Medical Group
    • Torrance, California, United States, 90505
      • AV Institute, Inc.
    • Westminster, California, United States, 92683
      • Neuropsychiatric Institute of Orange County
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Geriatric and Adult Psych
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Comprehensive NeuroScience, Inc.
  • Florida
    • Ft. Lauderdale, Florida, United States, 33319
      • Professional Clinical Research Inc.
    • Jacksonville, Florida, United States, 32256
      • Amit Vijapura, MD
    • Miami, Florida, United States, 33180
      • Tukoi Inst for Clinical Research
    • North Miami, Florida, United States, 33161
      • BioQuan Research Group, Inc.
    • North Miami, Florida, United States, 33161
      • Scientific Clinical Research, Inc.
    • Sebring, Florida, United States, 33870
      • Mark Ashby, MD
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials, LLC
  • Hawaii
    • Honolulu, Hawaii, United States, 96826
      • Hawaii Clinical Research Center
  • Illinois
    • Oakbrook Terrace, Illinois, United States, 60181
      • Midwest Center for Neurobehavioral Medicine
    • Schaumburg, Illinois, United States, 60194
      • Peryam and Kroll Health Care Research
    • Skokie, Illinois, United States, 60077
      • Clintell, Inc.
  • Kansas
    • Prairie Village, Kansas, United States, 66206
      • CTT Research
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Lake Charles Clinical Trials
    • New Orleans, Louisiana, United States, 70114
      • Louisiana Research Associates, Inc
    • Shreveport, Louisiana, United States, 71103
      • LSU Health Sciences Center
  • Missouri
    • St. Charles, Missouri, United States, 63301
      • Saaid Khojasteh & Assoc, Inc
    • St. Louis, Missouri, United States, 63108
      • Medex Healthcare Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Neuroscience, Inc.
  • New York
    • Bronx, New York, United States, 10467
      • Anxiety and Depression Clinic at Montefiore Medical Center
    • Brooklyn, New York, United States, 11223
      • Brooklyn Medical Institute
    • Elmsford, New York, United States, 10523
      • Advanced Bio-Behavioral Science, Inc
    • Staten Island, New York, United States, 10304
      • Saint Vincent Catholic Medical Centers of New York
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • Lutheran Hospital
    • Middleburg Heights, Ohio, United States, 44130
      • Southwest Cleveland Sleep Center, Inc.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73101
      • IPS Research Company
  • Pennsylvania
    • Moon Township, Pennsylvania, United States, 15108
      • Crossroads Counseling & Consulting Associates
    • Philadelphia, Pennsylvania, United States, 19149
      • CNS Research Institute (CRI)
  • South Carolina
    • Charleston, South Carolina, United States, 29405
      • Segal Institute
  • Tennessee
    • Johnson City, Tennessee, United States, 37601
      • Harmony Research
  • Texas
    • Dallas, Texas, United States, 75235
      • UT Southwestern Medical Center
    • Desoto, Texas, United States, 75115
      • The Cedars Hospital, InSite Clinical Research
    • Houston, Texas, United States, 77074
      • Felin-Jennings Clinic
    • Lake Jackson, Texas, United States, 77566
      • R&D Clinical Research, Inc.
  • Washington
    • Seattle, Washington, United States, 98126
      • America's Doctor/Essential Doctor, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Individuals eligible for enrollment into this study are male and female adult patients who:

• Are 18 to 75 years of age
• Have a diagnosis of major depressive disorder with psychotic features (DSM-IV 296.24 or 296.34)
• Are able to provide written informed consent.

Exclusion Criteria:

Individuals not eligible to be enrolled into the study are those who:

• Have a major medical problem
• Have previously participated in a CORLUX (C-1073, mifepristone) clinical trial
• Have a history of an allergic reaction to CORLUX (C-1073, mifepristone).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: mifepristone matched placebo; daily for 7 days
Experimental: mifepristone 300 mg	Drug: mifepristone; mifepristone 300 mg daily for 7 dats
Experimental: mifepristone 600 mg	Drug: mifepristone 600 mg; mifepristone 600 mg daily for 7 days
Experimental: mifepristone 1200 mg	Drug: mifepristone 1200 mg; mifepristone 1200 mg daily for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change in a measure of psychosis	screen, Days 0, 7, 14, 28, 42, 56

Secondary Outcome Measures

Outcome Measure	Time Frame
The change in a measure of depression	screen, Days 0,7, 14, 28, 42, 56

Collaborators and Investigators

• Sponsor: Corcept Therapeutics

Publications and helpful links

General Publications

• Brogden RN, Goa KL, Faulds D. Mifepristone. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential. Drugs. 1993 Mar;45(3):384-409. doi: 10.2165/00003495-199345030-00007. Erratum In: Drugs 1993 Aug;46(2):268.
• 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.
• 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.
• Kruizinga J, Liemburg E, Burger H, Cipriani A, Geddes J, Robertson L, Vogelaar B, Nolen WA. Pharmacological treatment for psychotic depression. Cochrane Database Syst Rev. 2021 Dec 7;12(12):CD004044. doi: 10.1002/14651858.CD004044.pub5.
• 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.

Helpful Links

• Corcept Therapeutics

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: August 8, 2005
• First Submitted That Met QC Criteria: August 8, 2005
• First Posted (Estimate): August 10, 2005

Study Record Updates

• Last Update Posted (Estimate): February 15, 2012
• Last Update Submitted That Met QC Criteria: February 14, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Depression; Psychosis; Major Depression; PMD; Psychotic Depression; Psychotic Major Depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Depression; Depressive Disorder; Disease; Psychotic Disorders; Mental Disorders; Depressive Disorder, Major; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Abortifacient Agents; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Mifepristone
• Other Study ID Numbers: C-1073-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No