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| Sponsored by: |
Corcept Therapeutics |
|---|---|
| Information provided by: | Corcept Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00128505 |
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 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 |
|---|---|---|
|
Major Depressive Disorder Psychotic Disorders |
Drug: Mifepristone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety Study |
| Official Title: | An International, 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: | August 2005 |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Bulgaria | |
| Svetlozar H Haralanov Ph.D. | |
| Sofia, Bulgaria | |
| Luchezar G Hranov M.D. | |
| Sofia, Bulgaria | |
| Georgy Koychev M.D. | |
| Sofia, Bulgaria | |
| Georgi Popov M.D. | |
| Varna, Bulgaria | |
| Vihra Milanova M.D. | |
| Sofia, Bulgaria | |
| Croatia | |
| Goran Dodig M.D./Ph.D. | |
| Split, Croatia | |
| Pavo Filakovic M.D./Ph.D. | |
| Osijek, Croatia | |
| Vera Folnegovic-Smalc M.D/Ph.D | |
| Zagreb, Croatia | |
| Miro Jakovljevic M.D. | |
| Zagreb, Croatia | |
| Ljiljana Moro M.D./Ph.D. | |
| Rijeka, Croatia | |
| Dubravka Kocijan-Hercigonja M.D. | |
| Zagreb, Croatia | |
| Romania | |
| Aurel Nirestean M.D./Ph.D | |
| Targu Mures, Romania | |
| Mihai Dumitru Gheorge | |
| Bucharest, Romania | |
| Serbia and Montenegro | |
| Vladimir Diligenski M.D. | |
| Belgrade, Serbia and Montenegro | |
| Jelena Martinovic M.D. | |
| Belgrade, Serbia and Montenegro | |
| Ratomir Lisulov M.D. | |
| Novi Sad, Serbia and Montenegro | |
| Vladimir Paunovic M.D. | |
| Belgrade, Serbia and Montenegro | |
| Ivana Timotijevic M.D. | |
| Belgrade, Serbia and Montenegro | |
| Dragana Ignjatovic-Ristic M.D. | |
| Kragujevac, Serbia and Montenegro | |
| Study Director: | Katherine Beebe, PhD | Corcept Therapeutics |
More Information
| Study ID Numbers: | C-1073-13 |
| Study First Received: | August 8, 2005 |
| Last Updated: | February 22, 2007 |
| ClinicalTrials.gov Identifier: | NCT00128505 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Croatia: Ministry of Health and Social Care; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Romania: Ministry of Health, National Medicines Agency; Bulgaria: Ministry of Health |
|
PMD Depression Psychosis Psychotic Major Depression Major Depression |
|
Depression Contraceptive Agents Hormone Antagonists Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Mifepristone Depressive Disorder, Major Contraceptives, Postcoital |
Depressive Disorder Hormones Recurrence Behavioral Symptoms Schizophrenia Mental Disorders Mood Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
|
Contraceptives, Postcoital, Synthetic Contraceptive Agents Hormone Antagonists Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Depressive Disorder, Major Reproductive Control Agents Pathologic Processes Mental Disorders Therapeutic Uses Abortifacient Agents Menstruation-Inducing Agents |
Contraceptives, Oral, Synthetic Psychotic Disorders Schizophrenia and Disorders with Psychotic Features Abortifacient Agents, Steroidal Disease Depression Mifepristone Depressive Disorder Contraceptives, Postcoital Luteolytic Agents Pharmacologic Actions Behavioral Symptoms Mood Disorders |