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| Sponsored by: |
Corcept Therapeutics |
|---|---|
| Information provided by: | Corcept Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00128479 |
Purpose
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 |
|---|---|---|
|
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, 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) |
Eligibility| 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:
Contacts and Locations
Show 44 Study Locations| Study Director: | Katherine Beebe, PhD | Corcept Therapeutics |
More Information
| Study ID Numbers: | C-1073-06 |
| Study First Received: | August 8, 2005 |
| Last Updated: | February 22, 2007 |
| ClinicalTrials.gov Identifier: | NCT00128479 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
PMD Psychotic Depression Psychosis |
Major Depression Depression Psychotic Major Depression |
|
Depression Contraceptive Agents Hormone Antagonists Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Psychotropic Drugs Mifepristone Depressive Disorder, Major Contraceptives, Postcoital |
Depressive Disorder Hormones Behavioral Symptoms Schizophrenia Mental Disorders Mood Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features Antidepressive Agents |
|
Contraceptives, Postcoital, Synthetic Contraceptive Agents Hormone Antagonists Contraceptives, Oral Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Psychotropic Drugs Contraceptive Agents, Female Depressive Disorder, Major Reproductive Control Agents Pathologic Processes Mental Disorders Therapeutic Uses Abortifacient Agents Menstruation-Inducing Agents |
Contraceptives, Oral, Synthetic Psychotic Disorders Antidepressive Agents Schizophrenia and Disorders with Psychotic Features Abortifacient Agents, Steroidal Disease Depression Mifepristone Luteolytic Agents Depressive Disorder Contraceptives, Postcoital Pharmacologic Actions Behavioral Symptoms Mood Disorders Central Nervous System Agents |