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
NCT ID: NCT01575561
Last Updated: 2016-08-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
377 participants
INTERVENTIONAL
2012-06-30
2015-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lurasidone
Lurasidone 20, 40, 60,80 mg flexible dose
Lurasidone
Lurasidone 20-80 mg taken orally once daily
Interventions
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Lurasidone
Lurasidone 20-80 mg taken orally once daily
Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lurasidone Medical Director, MD
Role: STUDY_DIRECTOR
Sumitomo Pharma America, Inc.
Locations
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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
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
Clinica Privada de Salud Mental Santa Teresa de Avila
Buenos Aires, , Argentina
Novain Neurociencias Group
Buenos Aires, , Argentina
Instituto Nacional de Psicopatología (INAPSI)
Buenos Aires, , Argentina
Fundacion para el estudio y tratamiento de las enfermedades mentales (FETEM)
Buenos Aires, , Argentina
Instituto DAMIC SRL
Córdoba, , Argentina
Centro de Investigacion y Asistencia en Psiquiatria (CIAP)
Rosario, , Argentina
Center for Mental Health
Rousse, , Bulgaria
Multiprofiled Hospital for Active Treatment "Alexandrovska"
Sofia, , Bulgaria
Military Medical Academy
Sofia, , Bulgaria
Hospital El Pino
Santiago, , Chile
Clinica Pedro Montt
Santiago, , Chile
Saint Anne, s.r.o., Psychiatricke oddeleni
Brno - Mesto, , Czechia
Psychiatricka ambulance
Havířov, , Czechia
Psychiatricka lecebna U Honzicka
Písek, , Czechia
Clintrial s.r.o.
Prague, , Czechia
Psychiatricka ambulance
Prague, , Czechia
Psychiatricka ambulance
Prague, , Czechia
Psychiatricka ambulance Prosek
Prague, , Czechia
Telemens, s.r.o.
Přerov, , Czechia
CHS La Chartreuse - Pôle 6
Dijon, , France
Centre Hospitalier Spécialisé du Jura - Centre Médico Psychiatrique
Dole, , France
Centre Hospitalier Régional Universitaire
Nîmes, , France
Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika
Budapest, , Hungary
Nyiro Gyula Korhaz, I. Pszichiatria
Budapest, , Hungary
Nyiro Gyula Korhaz, II. Pszichiatria
Budapest, , Hungary
Nyiro Gyula Korhaz
Budapest, , Hungary
Goryokai Medical Corporation
Sapporo, Hokkaido, Japan
Asakayama General Hospital
Sakai, Osaka, Japan
Yuge Hospital
Kumamoto, , Japan
Nishigahara Hospital
Tokyo, , Japan
Kawada Hospital
Toyama, , Japan
NZOZ Syntonia
Gdynia, , Poland
NZOZ BioMed
Kielce, , Poland
NZOZ Prywatna Klinika Psychiatryczna Inventiva
Tuszyn, , Poland
State Healthcare and Forensic Psychiatric Expertise Institution
Izhevsk, , Russia
Saint Petersburg State Healthcare Institution "City psycho-neurology Dispanser #7"
Saint Petersburg, , Russia
St Petersburg State Government Healthcare Institution
Saint Petersburg, , Russia
St. Petersburg State Healthcare Institution "City Clinical Hospital #4"
Saint Petersburg, , Russia
Mental Health Research Institute of Siberian Branch of RAMS
Tomsk, , Russia
Nizhny Novgorod Regional State Institution of Healthcare
Veliky Novgorod, , Russia
Clinical Hospital Centre Dragisa Misovic
Belgrade, , Serbia
Clinical Centre Kragujevac, Psychiatric Hospital
Kragujevac, , Serbia
Clinic for Mental Health Protection, Clinical Centre Nis
Niš, , Serbia
Specialized Hospital for Psychiatric Diseased "Sveti Vracevi"
Novi Kneževac, , Serbia
Psychiatricke oddelenie, Vseobecna nemocnica Rimavska Sobota NaP n.o.
Rimavská Sobota, , Slovakia
Psychiatricka ambulancia
Zlaté Moravce, , Slovakia
Countries
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Other Identifiers
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2011-004789-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D1050308
Identifier Type: -
Identifier Source: org_study_id
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