The Young Adult and Pediatric Bipolar Study

Inclusion criteria

• Key Inclusion Criteria:

• DSM-IV diagnosis of bipolar I disorder, most recent episode manic or mixed.
• A lifetime history of bipolar disorder symptoms for at least 2 months.
• YMRS score greater than or equal to 16.
• CGI-S score greater than or equal to 4.
• Male or female outpatient aged between 10-17 years old inclusive at the time of consent.
• Functioning at an age-appropriate level intellectually, as deemed by the Investigator.
• The subject has no co-morbid illness that could affect efficacy, safety, or tolerability or in any way interfere with the subject's participation in the study.
• Must have a satisfactory medical assessment with no clinically significant and relevant abnormalities.

Exclusion criteria

• Key Exclusion Criteria:

• Current controlled or uncontrolled, co-morbid psychiatric diagnosis that could interfere with clinical assessments or study conduct.
• A history of lack of therapeutic response or hypersensitivity to the study drug.
• A greater than or equal to 50% reduction in YMRS between Screening and Baseline.
• Acutely at risk for suicidal or violent behavior or a history of suicide attempts requiring medical intervention.
• A history of aplastic anemia, agranulocytosis or bone marrow depression.
• A history of seizure disorder, other than a single childhood febrile seizure.
• A history of severe, unstable asthma.
• Current hospitalization for psychiatric symptoms.
• History of alcohol or other substance abuse or dependence.
• Pregnant or lactating females.
• Body weight less than or equal to 25 kg.