drugset / Trial / NCT01128114
Study of the Broad Clinical Benefit for Seroquel XR With Flexible Dose as an add-on Therapy in the Treatment of Acute Bipolar Mania Patients With Partial Response to Current Therapy
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of this study is to evaluate the broad clinical benefit of dosing Seroquel XR with flexible in the treatment of acute bipolar mania patients with partial response to existing therapy. Clinical benefit will be assessed with the Clinical Global Impression-Clinical Benefit (CGI-CB) score, according to a classification based on the principles outlined in the CGI efficacy index. Improvement in clinical benefit will be defined as a decrease from baseline in CGI-CB.
Timeline
- Start
- 2010-06
- Primary completion
- 2011-03
- Completion
- 2011-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |