Conditions: Bipolar Disorder
Keywords: Manic or mixed episode associated with bipolar I disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 224
Healthy volunteers: no

Brief summary:
The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar I disorder.

Detailed description:

Arms:
arm 1: olanzapine: 5 to 20 mg per day for 6 weeks arm 2: haloperidol: 2.5 to 10 mg per day for 6 weeks arm 3: placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks

Interventions: intervention 1: olanzapine intervention 2: haloperidol intervention 3: placebo
Intervention descriptions: intervention 1: 5-20 mg, oral, once daily (evening), for 6 weeks intervention 2: 2.5-10 mg, oral, twice daily (morning and evening), for 6 weeks. intervention 3: placebo, oral tablets, twice daily (morning and evening), for 3 weeks

Protocol document: