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 |
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
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.
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).
We found this trial at
26
sites
Dallas, Texas 75235
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Stanford University School of Medicine Vast in both its physical scale and its impact on...
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Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Palo Alto, California 94304
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