Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351169
Status:
COMPLETED
Last Update Posted:
2008-12-22
First Post:
2006-07-11
Brief Title:
Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Multi-Centre Double-Blind Randomised Parallel Group Placebo- Controlled and Active Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release Seroquel SRTM as Mono- Therapy in the Treatment of Adult Patients With Major Depressive Disorder
Status:
COMPLETED
Status Verified Date:
2007-12
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:
AMBER
Brief Summary:
To evaluate the efficacy and safety of quetiapine fumarate sustained release Seroquel SR in the treatment of Major Depressive Disorder
PLEASE NOTE Seroquel SR and Seroquel XR refer to the same formulation The SR designation was changed to XR after consultation with FDA
PLEASE NOTE Seroquel SR and Seroquel XR refer to the same formulation The SR designation was changed to XR after consultation with FDA
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT No 2005-005052-40 | None | None | None |
| AMBER | None | None | None |