Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex

This study is to evaluate the efficacy and safety of lurasidone (in combination with lithium
or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or
without rapid cycling and/or psychotic features.

Inclusion Criteria:

Open-label Phase

- 18 years of age or older

- Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision
(DSM-IV-TR) diagnosis of bipolar I disorder

•≥ 1 manic, mixed manic, or depressed episode in past 2 years

- YMRS or MADRS total score ≥ 14 if on lithium or divalproex; ≥ 18 if not on lithium or
divalproex

Double-blind Phase

Inclusion Criteria:

- Subjects must achieve consistent clinical stability, defined as total scores ≤ 12 on
the YMRS and MADRS over at least 12 weeks, with the allowance of two excursions (YMRS
and/or MADRS total scores up to 13 or 14, respectively) except during the last 4
weeks before randomization

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