Depressive Disorder, Major Clinical Trial
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
Verified date | February 2012 |
Source | Corcept Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 87 |
Est. completion date | November 2006 |
Est. primary completion date | November 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Completed participation through Day 56 in Corcept Therapeutics Protocol C-1073-07 - Are 18 to 75 years of age - Have a diagnosis of major depressive disorder with psychotic features (DSM-IV 296.24 or 296.34) - Are able to provide written informed consent Exclusion Criteria: - Have a major medical problem - Have a history of an allergic reaction to Corlux (C-1073, mifepristone) |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Atlanta Center for Medical Research | Atlanta | Georgia |
United States | Claghorn-Lesem Research Clinic | Bellaire | Texas |
United States | Northwest Clinical Research Center | Bellevue | Washington |
United States | CNS Research Institute (CRI) | Clementon | New Jersey |
United States | Zucker Hillside Hospital | Glen Oaks | New York |
United States | Robert Horne M.D. | Las Vegas | Nevada |
United States | Neurobehavioral Research, Inc. | Lawrence | New York |
United States | New Jersey Medical School - UMDNJ | Newark | New Jersey |
United States | IPS Research Company | Oklahoma City | Oklahoma |
United States | CNS Research Institute (CRI) | Philadelphia | Pennsylvania |
United States | International Clinical Research Associates | Richmond | Virginia |
United States | Cnri, Llc | San Diego | California |
United States | BioBehavioral Health | Toms River | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Corcept Therapeutics |
United States,
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 | To evaluate the safety and tolerability of Corlux (mifepristone) for the treatment of recurrent psychotic symptoms with major depression with psychotic features (PMD) who previously participated in Corcept Therapeutics Protocol C-1073-07 | |||
Secondary | To assess the frequency of retreatment with Corlux in patients with PMD and qualitatively describe the psychotic symptoms for which retreatment is clinically indicated |
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