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

Phase 3

Completed

Conditions: Bipolar I Disorder

Interventions: Drug: Lurasidone

Registration Number: NCT01575561

Lead Sponsor: Sumitomo Pharma America, Inc.

Brief Summary: 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

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 377

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lurasidone	Lurasidone	Lurasidone 20, 40, 60,80 mg flexible dose

Primary Outcome Measures

Name	Time	Method
Treatment-emergent Adverse Events and Treatment-emergent Adverse Events Leading to Discontinuation and Serious Adverse Events	12 weeks	Number of subjects with treatment emergent AEs, SAEs, and TEAEs leading to discontinuation

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Week 12 (LOCF) in the YMRS Total Score -Mania as Assessed by Young Mania Rating Scale (YMRS)	Baseline, 12 weeks (LOCF)	Movement disorders as assessed by Young Mania Rating Scale (YMRS) The YMRS is an 11-item instrument used to assess the severity of mania in subjects with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score). The YMRS total score is calculated as the sum of the 11 items. The YMRS total score ranges from 0 to 60. Higher scores are associated with greater severity of mania.
Change From Baseline to Week 12 (LOCF) in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) Total Score	baseline, 12 weeks (LOCF)	The QIDS-SR16 is a 16-item self-report measure of depressive symptomatology which uses a computerized assessment interface for administration. The scoring system for the QIDS-SR16 converts responses to 16 separate items into nine DSM-IV symptom criterion domains. The nine domains comprise: depressed mood (Item 5); concentration/decision making (Item 10); self outlook (Item 11); suicidal ideation (Item 12); decreased interest (Item 13); decreased energy (Item 14); sleep disturbance (initial, middle, and late insomnia or hypersomnia) (highest score of Items 1 to 4); appetite/weight disturbance (highest score of Items 6 to 9); and psychomotor disturbance (highest score of Items 15 and 16). The QIDS-SR16 total score is calculated as the sum of the 9 domain scores. The QIDS-SR16 total score ranges from 0 to 27 with a high score indicating more severe symptoms.
Change From Baseline to Week 12 (LOCF) in the Positive and Negative Syndrome Scale Positive Subscale (PANSS P) Score	baseline, 12 weeks (LOCF)	The PANSS-P is a subset of items in the PANSS, an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS-P subscale score is the sum of the 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.
Change From Baseline to Week 12 (LOCF) in the MADRS Total Score- Depression as Assessed by Montgomery-Asberg Depression Rating Scale (MADRS)	baseline ,Week 12 (LOCF)	Depression as assessed by Montgomery-Asberg Depression Rating Scale (MADRS) -The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity of depression.
Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Overall Score- Severity of Illness as Assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S)	baseline, week 12 (LOCF)	Severity of illness as assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) -The CGI-BP-S overall score is a single value, clinician-rated assessment of overall bipolar illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.
Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Mania Score	baseline, week 12 (LOCF)	The CGI-BP-S mania score is a single value, clinician-rated assessment of mania illness severity and ranges from 1=Normal, not at all ill to 7= Among the most extremely ill patients. A higher score is associated with greater illness severity
Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Depression Scale	baseline, week 12 (LOCF)	The CGI-BP-S depression score is a single value, clinician-rated assessment of depression illness severity and range from 1=normal, not at all ill to 7=Among the most extremely ill patients. A higher score is associated with greater illness severity.
Change From Baseline to Week 12 (LOCF) in the SDS Total Score	baseline, week 12 (LOCF)	The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient's life are impaired by depressive symptoms. The SDS total score is calculated as the sum of the 3 items. The SDS total score ranges from 0 to 30. Higher scores are associated with greater severity of global functional impairments. If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing.

Trial Locations

Locations (68): Atlanta Center for Medical Research
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Atlanta, Georgia, United States
Psychoneuroendocrinology Research Group, Dept of Psychiatry, UT Southwestern Medical Center
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Dallas, Texas, United States
NZOZ BioMed
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Kielce, Poland
NZOZ Prywatna Klinika Psychiatryczna Inventiva
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Tuszyn, Poland
Psychiatricka ambulancia
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Zlate Moravce, Slovakia
Nyiro Gyula Korhaz, I. Pszichiatria
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Budapest, Hungary
NZOZ Syntonia
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Gdynia, Poland
Psychiatricka lecebna U Honzicka
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Pisek, Czech Republic
Clintrial s.r.o.
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Praha, Czech Republic
Psychiatricka ambulance Prosek
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Praha, Czech Republic
Center for Mental Health
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Rousse, Bulgaria
Saint Anne, s.r.o., Psychiatricke oddeleni
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Brno - mesto, Czech Republic
Clinical Centre Kragujevac, Psychiatric Hospital
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Kragujevac, Serbia
Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika
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Budapest, Hungary
State Healthcare and Forensic Psychiatric Expertise Institution
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Izhevsk, Russian Federation
Novain Neurociencias Group
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Buenos Aires, Argentina
Instituto DAMIC SRL
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Cordoba, Argentina
Centro de Investigacion y Asistencia en Psiquiatria (CIAP)
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Rosario, Argentina
Clinical Hospital Centre Dragisa Misovic
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Belgrade, Serbia
Hospital El Pino
🇨🇱
Santiago, Chile
Clinica Pedro Montt
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Santiago, Chile
Neuropsychiatric Research Center of Orange County
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Santa Ana, California, United States
Behavioral Research Specialists, LLC
🇺🇸
Glendale, California, United States
Florida Clinical Research LLC
🇺🇸
Bradenton, Florida, United States
AXIS Clinical Trials
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Los Angeles, California, United States
Telemens, s.r.o.
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Prerov, Czech Republic
CHS La Chartreuse - Pôle 6
🇫🇷
Dijon cedex, France
Nyiro Gyula Korhaz, II. Pszichiatria
🇭🇺
Budapest, Hungary
Clinical Neuroscience Solutions Inc.
🇺🇸
Memphis, Tennessee, United States
Psychiatricke oddelenie, Vseobecna nemocnica Rimavska Sobota NaP n.o.
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Rimavska Sobota, Slovakia
Galiz Research
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Miami Springs, Florida, United States
Finger Lakes Clinical Research
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Rochester, New York, United States
Goryokai Medical Corporation
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Sapporo-shi, Hokkaido, Japan
Centre Hospitalier Régional Universitaire
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Nimes, France
Nizhny Novgorod Regional State Institution of Healthcare
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Novgorod, Russian Federation
Mental Health Research Institute of Siberian Branch of RAMS
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Tomsk, Russian Federation
Yuge Hospital
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Kumamoto, Japan
Kawada Hospital
🇯🇵
Toyama, Japan
Suburban Research Associates
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Media, Pennsylvania, United States
Clinica Privada de Salud Mental Santa Teresa de Avila
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Buenos Aires, Argentina
Cutting Edge Research Group
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Oklahoma City, Oklahoma, United States
Carolina Clinical Trials
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Charleston, South Carolina, United States
Nyiro Gyula Korhaz
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Budapest, Hungary
Centre Hospitalier Spécialisé du Jura - Centre Médico Psychiatrique
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Dole, France
Instituto Nacional de Psicopatología (INAPSI)
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Buenos Aires, Argentina
St. Petersburg State Healthcare Institution "City Clinical Hospital #4"
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St. Petersburg, Russian Federation
Harmonex Neuroscience Research
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Dothan, Alabama, United States
Excell Research, Inc
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Oceanside, California, United States
SF-Care, Inc.
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San Francisco, California, United States
Stanford University School of Medicine
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Stanford, California, United States
Stanford University School of Medicine Research Program VA Palo Alto Health Care System
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Palo Alto, California, United States
Clinco
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Terre Haute, Indiana, United States
Activ Med Practices & Research
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Haverhill, Massachusetts, United States
Psych Care Consultants Research
🇺🇸
St. Louis, Missouri, United States
Lincoln Research
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Lincoln, Rhode Island, United States
Charak Clincial Research Center
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Garlield Heights, Ohio, United States
Fundacion para el estudio y tratamiento de las enfermedades mentales (FETEM)
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Buenos Aires, Argentina
R/D Clinical Research, Inc.
🇺🇸
Lake Jackson, Texas, United States
Multiprofiled Hospital for Active Treatment "Alexandrovska"
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Sofia, Bulgaria
Military Medical Academy
🇧🇬
Sofia, Bulgaria
Psychiatricka ambulance
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Praha, Czech Republic
Asakayama General Hospital
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Sakai, Osaka, Japan
Nishigahara Hospital
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Tokyo, Japan
St Petersburg State Government Healthcare Institution
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St Petersburg, Russian Federation
Saint Petersburg State Healthcare Institution "City psycho-neurology Dispanser #7"
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St. Petersburg, Russian Federation
Clinic for Mental Health Protection, Clinical Centre Nis
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Nis, Serbia
Specialized Hospital for Psychiatric Diseased "Sveti Vracevi"
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Novi Knezevac, Serbia
Clinical Neuroscience Solutions
🇺🇸
Orlando, Florida, United States