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



Status:Completed
Conditions:Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2012
End Date:July 2015

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A Multi-center, Open Label, Flexible Dose, Extension Study of Lurasidone Adjunctive to Lithium or Divalproex in Subjects With Bipolar I Disorder

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).
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291 Campus Dr
Stanford, California 94305
(650) 725-3900
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Bradenton, Florida 34201
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Charleston, South Carolina 29405
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Dothan, Alabama 36303
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Garlield Heights, Ohio 44125
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Glendale, California 91204
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Jacksonville, Florida 32216
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Terre Haute, Indiana 47802
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