Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00326105
Status:
COMPLETED
Last Update Posted:
2009-03-25
First Post:
2006-05-15
Brief Title:
Efficacy and Safety of Quetiapine Fumarate Sustained Release SEROQUEL SR in Combination With an Antidepressant in the Treatment of Major Depressive Disorders
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Multicenter Double-Blind Randomized Parallel-Group Placebo- Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release Seroquel SRTM in Combination With an Antidepressant in the Treatment of Patients With Major Depressive Disorder With Inadequate Response to an Antidepressant Treatment PEARL STUDY
Status:
COMPLETED
Status Verified Date:
2009-03
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:
PEARL
Brief Summary:
The purpose of this study is to evaluate the efficacy of quetiapine SR in combination with an antidepressant versus an antidepressant alone in patients with MDD with inadequate response to an antidepressant treatment
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 |
|---|---|---|---|
| PEARL | None | None | None |