Conditions: Acute Bipolar Mania
Keywords: Acute bipolar mania Seroquel XR Seroquel XR plus lithium Quetiapine fumarate
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 131
Healthy volunteers: no

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.

Arms:
arm 1: Seroquel XR tablet arm 2: Seroquel XR + lithium

Interventions: intervention 1: Quetiapine fumarate intervention 2: lithium
Intervention descriptions: intervention 1: eXtended Release(XR) 50mg, 200mg, 300mg and/or 400mg tablet, oral, once daily in the evening, from assignment to the end of the study. intervention 2: 300mg tablet, oral

Protocol document: