This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296 (PERSISTExt)

• Physical examination - general appearance, head, eyes, ears/nose/throat, neck, lymph nodes, skin, lungs, heart, abdomen, musculoskeletal, and neurologic evaluations. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  Physical examination - general appearance, head, eyes, ears/nose/throat, neck, lymph nodes, skin, lungs, heart, abdomen, musculoskeletal, and neurologic evaluations.
• Weight - Body Mass Index (BMI) will be calculated in kg/m2. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  Weight - Body Mass Index (BMI) will be calculated in kg/m2.
• Colombia Suicide Severity Rating Scale C-SSRS [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  Colombia Suicide Severity Rating Scale C-SSRS
• Movement disorders assessed by Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  Movement disorders assessed by Abnormal Involuntary Movement Scale (AIMS)
• Young Mania Rating Scale (YMRS) total score Montgomery-Asberg Depression Rating Scale (MADRS) total score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Young Mania Rating Scale (YMRS) total score Montgomery-Asberg Depression Rating Scale (MADRS) total score
• Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) total score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) total score
• Positive and Negative Syndrome Scale Positive Subscale (PANSS P) score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Positive and Negative Syndrome Scale Positive Subscale (PANSS P) score
• Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (overall, depression, mania) Sheehan Disability Scale (SDS) total score and SDS subscales [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (overall, depression, mania) Sheehan Disability Scale (SDS) total score and SDS subscales
• Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
• Pittsburgh Insomnia Rating Scale (PIRS-2) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Pittsburgh Insomnia Rating Scale (PIRS-2)
• Health Services Utilization Questionnaire (HSUQ) (US sites only) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Health Services Utilization Questionnaire (HSUQ) (US sites only)
• SF-12 Health Survey [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  SF-12 Health Survey
• Medication Satisfaction Questionnaire (MSQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Medication Satisfaction Questionnaire (MSQ)
• Intend to attend assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Intend to attend assessment
• Laboratory measures [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  Blood Chemistry Tests, Endocrine Tests, Hematology Tests, Urinalysis Tests, Urine Drug Screen
• Vital Signs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  Orthostatic changes in blood pressure and heart rate, blood pressure, pulse, respiratory rate, and temperature
• Electrocardiogram [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  12-lead ECG
• Movement disorders assessed by Barnes Akathisia Rating Scale (BARS) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  Movement disorders assessed by Barnes Akathisia Rating Scale (BARS)
• Movement disorders as assessed by Simpson-Angus Scale (SAS) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  Movement disorders as assessed by Simpson-Angus Scale (SAS)
• Mania as assessed by Young Mania Rating Scale (YMRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Movement disorders as assessed by Young Mania Rating Scale (YMRS)
• Depression as assessed by Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Depression as assessed by Montgomery-Asberg Depression Rating Scale (MADRS)
• Severity of illness as assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Severity of illness as assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S)
• Functionality as assessed by Sheehan Disability Scale (SDS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Functionality as assessed by Sheehan Disability Scale (SDS)

This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D1050296 or experienced a protocol defined recurrence of a mood event in the double-blind phase of the core study D1050296

To evaluate the longer term safety of lurasidone (20, 40, 60 or 80 mg/day) in subjects with bipolar I disorder.

Subjects will be initially treated with open-label lurasidone 40 mg/day (Day 1).

Dose adjustment of study drug (20, 40, 60 or 80 mg /day) should occur at the regularly scheduled visits and in increments/decrements of 1 dose level.

Inclusion Criteria:

• Subject has agreed to participate by providing written informed consent.
• Subject has completed the 28 week Double-blind Phase of Study D1050296 and all required assessments on the final study visit (Week 28, Visit 28); OR
• Subject has experienced a protocol-defined recurrence of any mood event during the Double blind Phase of Study D1050296 and has completed all required assessments on the final study visit; OR
• Subject had at least entered the Open-label Phase of Study D1050296 when the Sponsor stopped the study and has completed all required assessments on the final study visit.
• Subject is judged by the Investigator to be suitable for participation in a 12 week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.

Exclusion Criteria:

• Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.
• Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the Columbia Suicide Severity Rating Scale (C-SSRS) at the extension baseline visit (final study visit in Study D1050296).