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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Harmonex Neuroscience Research
Dothan, Alabama, United States
Behavioral Research Specialists, LLC
Glendale, California, United States
AXIS Clinical Trials
Los Angeles, California, United States
Excell Research, Inc
Oceanside, California, United States
Stanford University School of Medicine Research Program VA Palo Alto Health Care System
Palo Alto, California, United States
SF-Care, Inc.
San Francisco, California, United States
Neuropsychiatric Research Center of Orange County
Santa Ana, California, United States
Stanford University School of Medicine
Stanford, California, United States
Florida Clinical Research LLC
Bradenton, Florida, United States
Clinical Neuroscience Solutions Inc.
Jacksonville, Florida, United States
Start Date
June 1, 2012
Primary Completion Date
July 1, 2015
Completion Date
July 1, 2015
Last Updated
August 22, 2016
377
ACTUAL participants
Lurasidone
DRUG
Lead Sponsor
Sumitomo Pharma America, Inc.
NCT05303064
NCT07172516
Data Source & Attribution
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