Conditions: Manic or Mixed Episode Associated With Bipolar I Disorder
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 139
Healthy volunteers: no

Brief summary:
The efficacy and safety of the extended treatment to patients with most recent episode manic or mixed who completed previous double blind study (F1D-JE-BMAC \[Study BMAC\]) will be examined.

Detailed description:

Arms:
arm 1: Olanzapine extension for Study BMAC patients who completed Visit 8.

Patients received olanzapine 5-20 mg for 18 weeks. arm 2: Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5.

Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks.

Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.

Interventions: intervention 1: olanzapine intervention 2: lithium intervention 3: valproate intervention 4: carbamazepine
Intervention descriptions: intervention 1: oral, daily intervention 2: Dose adjusted according to local package insert intervention 3: Dose adjusted according to local package insert intervention 4: Dose adjusted according to local package insert

Protocol document: