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| Sponsor: | Corcept Therapeutics |
|---|---|
| Information provided by: | Corcept Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00130676 |
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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
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 23 Study Locations| Study Director: | Katherine Beebe, PhD | Corcept Therapeutics |
More Information
| ClinicalTrials.gov Identifier: | NCT00130676 History of Changes |
| Other Study ID Numbers: | C-1073-07 |
| Study First Received: | August 12, 2005 |
| Last Updated: | September 18, 2006 |
| Health Authority: | United States: Food and Drug Administration |
|
PMD Psychotic Major Depression Depression Major Depression Psychosis |
|
Depression Depressive Disorder Psychotic Disorders Mental Disorders Depressive Disorder, Major Behavioral Symptoms Mood Disorders Schizophrenia and Disorders with Psychotic Features Mifepristone Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents |
Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptives, Postcoital, Synthetic Contraceptives, Postcoital Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Luteolytic Agents Menstruation-Inducing Agents Abortifacient Agents, Steroidal Abortifacient Agents |