Ignite Creation Date:
2024-05-05 @ 11:07 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01254721
Status:
TERMINATED
Last Update Posted:
2014-05-08
First Post:
2010-12-03
Brief Title:
A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania An Open-label Randomized Parallel Groups Rater-blinded 4 Week Multicenter ComparativeStudy
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania An Open-label Randomized Parallel Groups Rater-blinded 4 Week Multicenter Comparative Phase 4 Study
Status:
TERMINATED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty of recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR
Brief Summary:
The primary objective of this study is to compare the efficacy of Seroquel XR monotherapy compared with Seroquel XR plus lithium in the treatment of acute bipolar mania by evaluation of the changes from baseline in Young Mania Ratings Scale YMRS total score to Day 29 using the last observation carried forward method
Detailed Description:
A comparison of the effectiveness of Seroquel XR and Seroquel XR plus lithium in patients with acute bipolar mania An open-label randomized parallel groups rater-blinded 4 week multicenter comparative phase 4 study
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