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| Sponsor: | 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: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 | |
| Vihra Milanova M.D. | |
| Sofia, Bulgaria | |
| Georgi Popov M.D. | |
| Varna, Bulgaria | |
| Croatia | |
| Pavo Filakovic M.D./Ph.D. | |
| Osijek, Croatia | |
| Ljiljana Moro M.D./Ph.D. | |
| Rijeka, Croatia | |
| Goran Dodig M.D./Ph.D. | |
| Split, Croatia | |
| Vera Folnegovic-Smalc M.D/Ph.D | |
| Zagreb, Croatia | |
| Miro Jakovljevic M.D. | |
| Zagreb, Croatia | |
| Dubravka Kocijan-Hercigonja M.D. | |
| Zagreb, Croatia | |
| Former Serbia and Montenegro | |
| Jelena Martinovic M.D. | |
| Belgrade, Former Serbia and Montenegro | |
| Vladimir Diligenski M.D. | |
| Belgrade, Former Serbia and Montenegro | |
| Ivana Timotijevic M.D. | |
| Belgrade, Former Serbia and Montenegro | |
| Vladimir Paunovic M.D. | |
| Belgrade, Former Serbia and Montenegro | |
| Dragana Ignjatovic-Ristic M.D. | |
| Kragujevac, Former Serbia and Montenegro | |
| Ratomir Lisulov M.D. | |
| Novi Sad, Former Serbia and Montenegro | |
| Romania | |
| Mihai Dumitru Gheorge | |
| Bucharest, Romania | |
| Aurel Nirestean M.D./Ph.D | |
| Targu Mures, Romania | |
| Study Director: | Katherine Beebe, PhD | Corcept Therapeutics |
More Information
| ClinicalTrials.gov Identifier: | NCT00128505 History of Changes |
| Other Study ID Numbers: | C-1073-13 |
| Study First Received: | August 8, 2005 |
| Last Updated: | February 22, 2007 |
| 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 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 |