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Sponsored by: |
Corcept Therapeutics |
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Information provided by: | Corcept Therapeutics |
ClinicalTrials.gov Identifier: | NCT00130676 |
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 |
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Major Depressive Disorder Psychotic Disorders |
Drug: Mifepristone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Individuals eligible for enrollment into this study are male and female adult patients who:
Exclusion Criteria:
Individuals not eligible to be enrolled into the study are those who:
Study Director: | Katherine Beebe, PhD | Corcept Therapeutics |
Study ID Numbers: | C-1073-07 |
Study First Received: | August 12, 2005 |
Last Updated: | September 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00130676 |
Health Authority: | United States: Food and Drug Administration |
PMD Psychotic Major Depression Depression |
Major Depression Psychosis Psychotic Major Depression |
Schizophrenia Depression Mental Disorders Mood Disorders Mifepristone |
Psychotic Disorders Depressive Disorder, Major Depressive Disorder Schizophrenia and Disorders with Psychotic Features Behavioral Symptoms |
Abortifacient Agents, Steroidal Contraceptives, Postcoital, Synthetic Disease Contraceptive Agents Hormone Antagonists Contraceptives, Oral Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female |
Reproductive Control Agents Luteolytic Agents Contraceptives, Postcoital Pharmacologic Actions Pathologic Processes Therapeutic Uses Abortifacient Agents Menstruation-Inducing Agents Contraceptives, Oral, Synthetic |