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
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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Dallas, Texas 75235
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Palo Alto, California 94304
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