Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128505
Status:
COMPLETED
Last Update Posted:
2012-02-15
First Post:
2005-08-08
Brief Title:
An International Extension Study of Corlux for Recurrent Psychotic Symptoms in Psychotic Major Depression
Sponsor:
Corcept Therapeutics
Organization:
Corcept Therapeutics
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Corlux mifepristone is a new medication that modulates the bodys 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 bodys 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None