Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex

Exclusion Criteria

• •Open Label Phase
• •Diagnosis of an Axis I or Axis II disorder, other than bipolar I disorder, that is the primary focus of treatment within 3 months of screening
• •Subjects for whom diagnostic agreement between the Investigator and United BioSource Corporation (Boston) (UBC) cannot be reached
• •Ultra-fast rapid cycling (defined as ≥ 8 mood episodes over the previous 12-month period)
• •Subjects who test positive for drugs of abuse at screening. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to abstain from cannabis during the study
• •Unstable/inadequately treated medical illness
• •The subjects answers "yes" to "Suicidal Ideation" items 4 or 5 on the C-SSRS (at time of evaluation)
• •Double Blind Phase
• •Subjects who in the Investigator's judgment have not been compliant with study medication during the stabilization phase
• •Subjects who have not stabilized during the open-label phase (within 20 weeks)
• •Subjects who test positive for drugs of abuse at double-blind phase baseline. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to abstain from cannabis during the study