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

Phase 3

Completed

• Conditions: Major Depressive Disorder; Psychotic Disorders
• Interventions: Drug: mifepristone 1200 mg; Drug: mifepristone matched placebo; Drug: mifepristone 600 mg; Drug: mifepristone

• Registration Number: NCT00128479
• Lead Sponsor: Corcept Therapeutics

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-08-08
• Study First Submitted QC: 2005-08-08
• Study First Posted: 2005-08-10
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-14
• Last Update Posted: 2012-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 443

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mifepristone 1200 mg	mifepristone 1200 mg	-
placebo	mifepristone matched placebo	-
mifepristone 600 mg	mifepristone 600 mg	-
mifepristone 300 mg	mifepristone	-

Primary Outcome Measures

Name	Time	Method
The change in a measure of psychosis	screen, Days 0, 7, 14, 28, 42, 56

Secondary Outcome Measures

Name	Time	Method
The change in a measure of depression	screen, Days 0,7, 14, 28, 42, 56

Trial Locations

Locations (44)

K&S Research Services; 🇺🇸 Little Rock, Arkansas, United States

Center for Emotional Fitness; 🇺🇸 Cerritos, California, United States

Harbor Medical Associates, Inc.; 🇺🇸 Fountain Valley, California, United States

Synergy Clinical Research Center; 🇺🇸 National City, California, United States

Excell Research; 🇺🇸 Oceanside, California, United States

Pacific Clinical Research Medical Group; 🇺🇸 Riverside, California, United States

AV Institute, Inc.; 🇺🇸 Torrance, California, United States

Neuropsychiatric Institute of Orange County; 🇺🇸 Westminster, California, United States

Geriatric and Adult Psych; 🇺🇸 Hamden, Connecticut, United States

Comprehensive NeuroScience, Inc.; 🇺🇸 Washington, District of Columbia, United States

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