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

Primary Purpose

Major Depressive Disorder, Psychotic Disorders

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
mifepristone
mifepristone matched placebo
mifepristone 600 mg
mifepristone 1200 mg
Sponsored by
Corcept Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring PMD, Psychotic Depression, Psychosis, Major Depression, Depression, Psychotic Major Depression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • K&S Research Services
  • Center for Emotional Fitness
  • Harbor Medical Associates, Inc.
  • Synergy Clinical Research Center
  • Excell Research
  • Pacific Clinical Research Medical Group
  • AV Institute, Inc.
  • Neuropsychiatric Institute of Orange County
  • Geriatric and Adult Psych
  • Comprehensive NeuroScience, Inc.
  • Professional Clinical Research Inc.
  • Amit Vijapura, MD
  • Tukoi Inst for Clinical Research
  • Bioquan Research Group, Inc.
  • Scientific Clinical Research, Inc.
  • Mark Ashby, MD
  • Stedman Clinical Trials, LLC
  • Hawaii Clinical Research Center
  • Midwest Center for Neurobehavioral Medicine
  • Peryam and Kroll Health Care Research
  • Clintell, Inc.
  • CTT Research
  • Lake Charles Clinical Trials
  • Louisiana Research Associates, Inc
  • LSU Health Sciences Center
  • Saaid Khojasteh & Assoc, Inc
  • Medex Healthcare Research
  • Albuquerque Neuroscience, Inc.
  • Anxiety and Depression Clinic at Montefiore Medical Center
  • Brooklyn Medical Institute
  • Advanced Bio-Behavioral Science, Inc
  • Saint Vincent Catholic Medical Centers of New York
  • Lutheran Hospital
  • Southwest Cleveland Sleep Center, Inc.
  • IPS Research Company
  • Crossroads Counseling & Consulting Associates
  • CNS Research Institute (CRI)
  • Segal Institute
  • Harmony Research
  • UT Southwestern Medical Center
  • The Cedars Hospital, InSite Clinical Research
  • Felin-Jennings Clinic
  • R&D Clinical Research, Inc.
  • America's Doctor/Essential Doctor, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

mifepristone 300 mg

placebo

mifepristone 600 mg

mifepristone 1200 mg

Arm Description

Outcomes

Primary Outcome Measures

The change in a measure of psychosis

Secondary Outcome Measures

The change in a measure of depression

Full Information

First Posted
August 8, 2005
Last Updated
February 14, 2012
Sponsor
Corcept Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00128479
Brief Title
A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corcept Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Psychotic Disorders
Keywords
PMD, Psychotic Depression, Psychosis, Major Depression, Depression, Psychotic Major Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
443 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mifepristone 300 mg
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
mifepristone 600 mg
Arm Type
Experimental
Arm Title
mifepristone 1200 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
mifepristone
Intervention Description
mifepristone 300 mg daily for 7 dats
Intervention Type
Drug
Intervention Name(s)
mifepristone matched placebo
Intervention Description
daily for 7 days
Intervention Type
Drug
Intervention Name(s)
mifepristone 600 mg
Intervention Description
mifepristone 600 mg daily for 7 days
Intervention Type
Drug
Intervention Name(s)
mifepristone 1200 mg
Intervention Description
mifepristone 1200 mg daily for 7 days
Primary Outcome Measure Information:
Title
The change in a measure of psychosis
Time Frame
screen, Days 0, 7, 14, 28, 42, 56
Secondary Outcome Measure Information:
Title
The change in a measure of depression
Time Frame
screen, Days 0,7, 14, 28, 42, 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Beebe, PhD
Organizational Affiliation
Corcept Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
K&S Research Services
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
Facility Name
Center for Emotional Fitness
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Harbor Medical Associates, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Synergy Clinical Research Center
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Excell Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
AV Institute, Inc.
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Neuropsychiatric Institute of Orange County
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Facility Name
Geriatric and Adult Psych
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Comprehensive NeuroScience, Inc.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Professional Clinical Research Inc.
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Amit Vijapura, MD
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Tukoi Inst for Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Bioquan Research Group, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Scientific Clinical Research, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Mark Ashby, MD
City
Sebring
State/Province
Florida
ZIP/Postal Code
33870
Country
United States
Facility Name
Stedman Clinical Trials, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Hawaii Clinical Research Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Midwest Center for Neurobehavioral Medicine
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
Facility Name
Peryam and Kroll Health Care Research
City
Schaumburg
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
Facility Name
Clintell, Inc.
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
CTT Research
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Lake Charles Clinical Trials
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Louisiana Research Associates, Inc
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
LSU Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Saaid Khojasteh & Assoc, Inc
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Medex Healthcare Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Albuquerque Neuroscience, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Anxiety and Depression Clinic at Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Brooklyn Medical Institute
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11223
Country
United States
Facility Name
Advanced Bio-Behavioral Science, Inc
City
Elmsford
State/Province
New York
ZIP/Postal Code
10523
Country
United States
Facility Name
Saint Vincent Catholic Medical Centers of New York
City
Staten Island
State/Province
New York
ZIP/Postal Code
10304
Country
United States
Facility Name
Lutheran Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Southwest Cleveland Sleep Center, Inc.
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73101
Country
United States
Facility Name
Crossroads Counseling & Consulting Associates
City
Moon Township
State/Province
Pennsylvania
ZIP/Postal Code
15108
Country
United States
Facility Name
CNS Research Institute (CRI)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19149
Country
United States
Facility Name
Segal Institute
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Harmony Research
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
The Cedars Hospital, InSite Clinical Research
City
Desoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Felin-Jennings Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
R&D Clinical Research, Inc.
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
America's Doctor/Essential Doctor, Inc
City
Seattle
State/Province
Washington
ZIP/Postal Code
98126
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7682909
Citation
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.
Results Reference
background
PubMed Identifier
12242054
Citation
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.
Results Reference
background
PubMed Identifier
11593077
Citation
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.
Results Reference
background
PubMed Identifier
34875106
Citation
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.
Results Reference
derived
PubMed Identifier
29523415
Citation
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.
Results Reference
derived
Links:
URL
http://www.corcept.com
Description
Corcept Therapeutics

Learn more about this trial

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

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