Conditions: Bipolar Disorder Bipolar Affective Psychosis Mania Manic Disorder Manic State
Keywords: Bipolar Disorder Bipolar Affective Psychosis Mania Manic Disorder Manic State
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 88
Healthy volunteers: no

Brief summary:
The primary purpose of the study is to assess the efficacy of Quetiapine extended release 600mg per day either as monotherapy or combined therapy in the treatment of patients with mania associated to Bipolar disorder. This trial will also assess the life quality and productivity loss improvement for patients from baseline to day 21.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Quetiapine 600mg
Intervention descriptions: intervention 1: 300 mg quetiapine fumarate tablets for oral use.

Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.

Protocol document: