Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128479
Status:
COMPLETED
Last Update Posted:
2012-02-15
First Post:
2005-08-08
Brief Title:
A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression
Sponsor:
Corcept Therapeutics
Organization:
Corcept Therapeutics
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel Group Study of the Safety and Efficacy of Three Dose Levels of CORLUX Mifepristone Plus an Antidepressant vs Placebo Plus an Antidepressant in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features PMD
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 56 day study is to learn the safety and effectiveness of Corlux in patients who have been diagnosed with psychotic major depression PMD
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