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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics
ClinicalTrials.gov Identifier:
NCT00128479
First received: August 8, 2005
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

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).


Condition Intervention Phase
Major Depressive Disorder
Psychotic Disorders
Drug: mifepristone
Drug: mifepristone matched placebo
Drug: mifepristone 600 mg
Drug: mifepristone 1200 mg
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Corcept Therapeutics:

Primary Outcome Measures:
  • The change in a measure of psychosis [ Time Frame: screen, Days 0, 7, 14, 28, 42, 56 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The change in a measure of depression [ Time Frame: screen, Days 0,7, 14, 28, 42, 56 ] [ Designated as safety issue: Yes ]

Enrollment: 443
Study Start Date: September 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mifepristone 300 mg Drug: mifepristone
mifepristone 300 mg daily for 7 dats
Placebo Comparator: placebo Drug: mifepristone matched placebo
daily for 7 days
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  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: NCT00128479

  Show 44 Study Locations
Sponsors and Collaborators
Corcept Therapeutics
Investigators
Study Director: Katherine Beebe, PhD Corcept Therapeutics
  More Information

Additional Information:
Publications:
Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT00128479     History of Changes
Other Study ID Numbers: C-1073-06
Study First Received: August 8, 2005
Last Updated: February 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Corcept Therapeutics:
PMD
Psychotic Depression
Psychosis
Major Depression
Depression
Psychotic Major Depression

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

ClinicalTrials.gov processed this record on August 21, 2014