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

NCT01128114

Phase 4 Terminated 32 enrolled AstraZeneca
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

EvaluationDrugModalityDoseRoute
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