Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder

Exclusion Criteria

• •Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of investigational product
• •A diagnosis of delirium, dementia, amnesia or other cognitive disorder, or a psychotic disorder
• •Current diagnosis of delirium, dementia, a cognitive disorder (ie, amnesia), or a psychotic disorder (ie, schizophrenia or schizoaffective disorder)
• •Current diagnosis of bipolar II disorder, bipolar disorder not otherwise specified, or any other primary psychiatric disorder other than bipolar I disorder mania
• •Thyroid pathology
• •Demonstrated cocaine abuse or dependence within the past 3 months prior to screening.
• •History of neuroleptic malignant syndrome from antipsychotic agents
• •Manic symptoms that investigator considers refractory to treatment
• •Previous nonresponsive (by investigator judgment) to aripiprazole for manic symptoms
• •Significant risk of suicide based on history, mental status exam, or investigator judgment.