Major Depressive Disorder Clinical Trial
Official title:
An International, Double-Blind, Placebo-Controlled, Study of the Efficacy and Safety of CORLUX™ (Mifepristone) vs. Placebo in the Treatment of Psychotic Symptoms in Patients With Psychotic Major Depression (PMD)
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).
Status | Completed |
Enrollment | 247 |
Est. completion date | July 2006 |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Are 18 to 75 years of age - Have a diagnosis of major depressive disorder with psychotic features (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM IV] 296.24 or 296.34) - Are able to provide written informed consent. Exclusion Criteria: - Have a major medical problem - Have previously participated in a Corlux (C-1073, mifepristone) clinical trial - Have a history of an allergic reaction to Corlux (C-1073, mifepristone). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Bulgaria | Georgy Koychev M.D. | Sofia | |
Bulgaria | Luchezar G Hranov M.D. | Sofia | |
Bulgaria | Svetlozar H Haralanov Ph.D. | Sofia | |
Bulgaria | Vihra Milanova M.D. | Sofia | |
Bulgaria | Georgi Popov M.D. | Varna | |
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 | Dubravka Kocijan-Hercigonja M.D. | Zagreb | |
Croatia | Miro Jakovljevic M.D. | Zagreb | |
Croatia | Vera Folnegovic-Smalc M.D./Ph.D. | Zagreb | |
Former Serbia and Montenegro | Ivana Timotijevic M.D. | Belgrade | |
Former Serbia and Montenegro | Jelena Martinovic M.D. | Belgrade | |
Former Serbia and Montenegro | Vladimir Diligenski 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 | |
Romania | Mihai Dumitru Gheorge | Bucharest | |
Romania | Aurel Nirestean M.D./Ph.D. | Targu Mures |
Lead Sponsor | Collaborator |
---|---|
Corcept Therapeutics |
Bulgaria, Croatia, Former Serbia and Montenegro, Romania,
Belanoff JK, Flores BH, Kalezhan M, Sund B, Schatzberg AF. Rapid reversal of psychotic depression using mifepristone. J Clin Psychopharmacol. 2001 Oct;21(5):516-21. — View Citation
Belanoff JK, Rothschild AJ, Cassidy F, DeBattista C, Baulieu EE, Schold C, Schatzberg AF. An open label trial of C-1073 (mifepristone) for psychotic major depression. Biol Psychiatry. 2002 Sep 1;52(5):386-92. — View Citation
Brogden RN, Goa KL, Faulds D. Mifepristone. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential. Drugs. 1993 Mar;45(3):384-409. Review. Erratum in: Drugs 1993 Aug;46(2):268. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change in a measure of psychosis | screening and on Days 0, 7, 14, 28, 42, and 56 | Yes | |
Secondary | The change in a measure of depression | screening and on Days 0, 7, 14, 28, 42, and 56 | Yes |
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