Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081380
Status:
COMPLETED
Last Update Posted:
2008-12-22
First Post:
2004-04-09
Brief Title:
Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Multicenter Randomized Parallel-Group Double-Blind Phase 3 Comparison of the Efficacy Safety of Quetiapine Fumarate to Placebo as Adjunct to Mood Stabilizers Lithium or Divalproex in the Maintenance Treatment of Bipolar I Disorder in Adult Patients Abbreviated
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder The study consists of enrollment and 2 phases the Open-label treatment Phase and the Randomized treatment Phase
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