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

Completed · Phase 3

Conditions studied: Bipolar I Disorder

In brief

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

Key facts

Study ID

NCT01575561

Run by

Sumitomo Pharma America, Inc.

People needed

377

Starts

2012-06-01

Expected to finish

2015-07-01

Last updated by the study team

2016-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• 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
• Galiz Research — Miami Springs, Florida, United States
• Clinical Neuroscience Solutions — Orlando, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Clinco — Terre Haute, Indiana, United States
• Activ Med Practices & Research — Haverhill, Massachusetts, United States
• Psych Care Consultants Research — St Louis, Missouri, United States
• Finger Lakes Clinical Research — Rochester, New York, United States
• Charak Clincial Research Center — Garlield Heights, Ohio, United States
• Cutting Edge Research Group — Oklahoma City, Oklahoma, United States
• Suburban Research Associates — Media, Pennsylvania, United States
• Lincoln Research — Lincoln, Rhode Island, United States
• Carolina Clinical Trials — Charleston, South Carolina, United States
• Clinical Neuroscience Solutions Inc. — Memphis, Tennessee, United States
• Psychoneuroendocrinology Research Group, Dept of Psychiatry, UT Southwestern Medical Center — Dallas, Texas, United States
• R/D Clinical Research, Inc. — Lake Jackson, Texas, United States
• Harmonex Neuroscience Research — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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