Trial record 10 of 866 for:
Completed, Suspended, Withdrawn Studies | Depression Psychotic | Industry
A United States Study of Corlux for Psychotic Symptoms in Psychotic Major Depression
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00130676 |
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Recruitment Status :
Completed
First Posted : August 16, 2005
Last Update Posted : February 15, 2012
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Sponsor:
Corcept Therapeutics
Information provided by (Responsible Party):
Corcept Therapeutics
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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).
| 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Depression
Drug Information available for:
Mifepristone
| Arm | Intervention/treatment |
|---|---|
| Experimental: mifepristone 600 mg |
Drug: Mifepristone
daily for 7 days |
| Placebo Comparator: matching placebo |
Drug: matching placebo
daily for 7 days |
Primary Outcome Measures :
- The change in a measure of psychosis [ Time Frame: screening and on Days 0, 7, 14, 28, 42, and 56 ]
Secondary Outcome Measures :
- The change in a measure of depression [ Time Frame: screening and on Days 0, 7, 14, 28, 42, and 56 ]
Information from the National Library of Medicine
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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 |
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)
Information from the National Library of Medicine
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
Locations
Show 23 study locations
Sponsors and Collaborators
Corcept Therapeutics
Investigators
| Study Director: | Katherine Beebe, PhD | Corcept Therapeutics |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Keywords provided by Corcept Therapeutics:
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PMD Psychotic Major Depression Depression Major Depression Psychosis |
Additional relevant MeSH terms:
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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 Menstruation-Inducing Agents |