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OpenTrials
Completed

NCT Number: NCT00128479

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

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).

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

K&S Research Services, Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mifepristone

Drug

mifepristone 300 mg daily for 7 dats

mifepristone matched placebo

Drug

daily for 7 days

mifepristone 600 mg

Drug

mifepristone 600 mg daily for 7 days

mifepristone 1200 mg

Drug

mifepristone 1200 mg daily for 7 days

Primary outcomes

  1. The change in a measure of psychosis

    Time frame: screen, Days 0, 7, 14, 28, 42, 56

Secondary outcomes

  1. The change in a measure of depression

    Time frame: screen, Days 0,7, 14, 28, 42, 56

Sponsors and collaborators

Lead sponsor

Corcept Therapeutics

Industry

Registry information

Official study 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)

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Aug 10, 2005
Registry last updated
Feb 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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