drugset / Trial / NCT01254721
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,Study
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2010-12
- Primary completion
- 2012-10
- Completion
- 2012-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lithium | Unknown | 300 mg | Oral |
| Subject | Quetiapine | Small molecule | 50 mg | Oral |
| Subject | Quetiapine | Small molecule | 200 mg | Oral |
| Subject | Quetiapine | Small molecule | 300 mg | Oral |
| Subject | Quetiapine | Small molecule | 400 mg | Oral |