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Sponsored by: |
Corcept Therapeutics |
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Information provided by: | Corcept Therapeutics |
ClinicalTrials.gov Identifier: | NCT00208156 |
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 study is to allow patients who have already participated in an earlier 8 week study of Corlux versus placebo (an inactive pill) to receive additional courses of treatment with Corlux periodically if a psychotic episode should reappear during a period of one year.
Condition | Intervention | Phase |
---|---|---|
Depressive Disorder, Major |
Drug: Mifepristone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment |
Official Title: | An Open-Label Extension Study of the Safety and Tolerability of CORLUX™ (Mifepristone) for Recurrent Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features |
Estimated Enrollment: | 110 |
Study Start Date: | May 2005 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
CNRI, LLC | |
San Diego, California, United States, 92126 | |
United States, Georgia | |
Atlanta Center for Medical Research | |
Atlanta, Georgia, United States, 30308 | |
United States, Nevada | |
Robert Horne M.D. | |
Las Vegas, Nevada, United States, 89102 | |
United States, New Jersey | |
New Jersey Medical School - UMDNJ | |
Newark, New Jersey, United States, 07101 | |
BioBehavioral Health | |
Toms River, New Jersey, United States, 08755 | |
CNS Research Institute (CRI) | |
Clementon, New Jersey, United States, 08021 | |
United States, New York | |
Neurobehavioral Research, Inc. | |
Lawrence, New York, United States, 11559 | |
Zucker Hillside Hospital | |
Glen Oaks, New York, United States, 11004 | |
United States, Oklahoma | |
IPS Research Company | |
Oklahoma City, Oklahoma, United States, 73101 | |
United States, Pennsylvania | |
CNS Research Institute (CRI) | |
Philadelphia, Pennsylvania, United States, 19149 | |
United States, Texas | |
Claghorn-Lesem Research Clinic | |
Bellaire, Texas, United States, 77401 | |
United States, Virginia | |
International Clinical Research Associates | |
Richmond, Virginia, United States, 23229 | |
United States, Washington | |
Northwest Clinical Research Center | |
Bellevue, Washington, United States, 98004 |
Study Director: | Katherine Beebe, PhD | Corcept Therapeutics |
Study ID Numbers: | C-1073-10 |
Study First Received: | September 13, 2005 |
Last Updated: | February 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00208156 |
Health Authority: | United States: Food and Drug Administration |
Depression Major Depression Psychotic Major Depression PMD Psychosis |
Schizophrenia Depression Mental Disorders Mood Disorders Mifepristone Psychotic Disorders |
Depressive Disorder, Major Depressive Disorder Schizophrenia and Disorders with Psychotic Features Recurrence 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 |