A United States Study of Corlux for Psychotic Symptoms in Psychotic Major Depression
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ClinicalTrials.gov Identifier: NCT00130676 |
Recruitment Status :
Completed
First Posted : August 16, 2005
Last Update Posted : February 15, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder Psychotic Disorders | Drug: Mifepristone Drug: matching placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 257 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of CORLUX™ (Mifepristone) in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features |
Study Start Date : | September 2004 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | June 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: mifepristone 600 mg |
Drug: Mifepristone
daily for 7 days |
Placebo Comparator: matching placebo |
Drug: matching placebo
daily for 7 days |
- The change in a measure of psychosis [ Time Frame: screening and on Days 0, 7, 14, 28, 42, and 56 ]
- The change in a measure of depression [ Time Frame: screening and on Days 0, 7, 14, 28, 42, and 56 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00130676

Study Director: | Katherine Beebe, PhD | Corcept Therapeutics |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Corcept Therapeutics |
ClinicalTrials.gov Identifier: | NCT00130676 |
Other Study ID Numbers: |
C-1073-07 |
First Posted: | August 16, 2005 Key Record Dates |
Last Update Posted: | February 15, 2012 |
Last Verified: | February 2012 |
PMD Psychotic Major Depression Depression Major Depression Psychosis |
Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Disease Pathologic Processes Behavioral Symptoms Mood Disorders Mifepristone 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 Contraceptive Agents, Hormonal Menstruation-Inducing Agents |