The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
615
Tablets/capsules, oral, 0 mg, once daily, 3 weeks (switched to arm B for an additional 9 weeks).
Tablets, oral, 15-30 mg, once daily, 12 weeks.
Capsule, oral, 5-15 mg, once daily, 12 weeks.
Change in a mania rating scale at endpoint
Response rate and Clinical Global Impression scale at endpoint
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