Conditions: Acute Mania in Bipolar Disorder
Keywords: Acute Mania Bipolar Disorder Quetiapine Fumarate Lithium
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 376
Healthy volunteers: no

Brief summary:
To compare the efficacy and safety of quetiapine fumarate given as mono-therapy or adjunct therapy to lithium in the treatment of patients with acute mania in bipolar disorder. Patients with a documented clinical diagnosis of bipolar mania according to DSM-IV criteria (296.4X Bipolar I Disorder, Most Recent Episode Manic; 296.0X Bipolar I Disorder, Single Manic Episode) are required to have a YMRS total score of ≥20 at enrolment and randomisation

Detailed description:

Arms:
arm 1: Quetiapine Fumarate - tablets arm 2: Quetiapine Fumarate - tablets and Lithium

Interventions: intervention 1: Quetiapine Fumarate intervention 2: Lithium
Intervention descriptions: intervention 1: Oral treatment, twice daily. 100 mg/day at Day 1, 200 mg/day at Day 2, 300 mg/day at Day 3, 400 mg/day at Day 4, from 400 mg/day to 600 mg/day before Day 8, from 600 mg/day to 800 thereafter, judged by the investigator.

Tablets intervention 2: Oral treatment, twice daily. 250 mg/day to 2000mg/day from Day1 to Day 7, 500mg/day to 2000mg/day thereafter, judged by the investigator.

Protocol document: