Conditions: Acute Mania
Keywords: Acute Mania Mania, Adults Seroquel Acute Mania in Adult Patients
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 356
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if lithium 600-1800 mg/day is effective when added to quetiapine fumarate extended release (quetiapine XR or SEROQUEL® XR) 400-800 mg/day in treating acute mania and if so, how it compares with placebo (a non-active capsule, like a sugar pill, that looks like lithium).

Detailed description:

Arms:
arm 1: Seroquel XR and Lithium arm 2: Seroquel XR and placebo

Interventions: intervention 1: Quetiapine fumarate XR intervention 2: Lithium intervention 3: Placebo
Intervention descriptions: intervention 1: Oral treatment, once daily, Day 1 = 300 mg, Day 2 and thereafter 600 mg. Dose might be adjusted as from Day 3 by the discretion of the investigator. intervention 2: Oral treatment, twice daily, Days 1 and 2 = 600 mg/day, Days 3-8 = 900 mg/day. Dose adjustment from day 9 to end of study will be at the discretion of the investigator. intervention 3: Oral treatment twice daily.

Protocol document: