Clinical trial NCT01575561: 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
Official title: A Multi-center, Open Label, Flexible Dose, Extension Study of Lurasidone Adjunctive to Lithium or Divalproex in Subjects With Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar I Disorder
Keywords: Lurasidone
Latuda
Bipolar Disorder
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-04-11
Enrollment: 377
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Treatment-emergent Adverse Events and Treatment-emergent Adverse Events Leading to Discontinuation and Serious Adverse Events
timeFrame: 12 weeks
Secondary outcomes:
measure: Change From Baseline to Week 12 (LOCF) in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) Total Score
timeFrame: baseline, 12 weeks (LOCF)
measure: Change From Baseline to Week 12 (LOCF) in the Positive and Negative Syndrome Scale Positive Subscale (PANSS P) Score
timeFrame: baseline, 12 weeks (LOCF)
measure: Change From Baseline to Week 12 (LOCF) in the YMRS Total Score -Mania as Assessed by Young Mania Rating Scale (YMRS)
timeFrame: Baseline, 12 weeks (LOCF)
measure: Change From Baseline to Week 12 (LOCF) in the MADRS Total Score- Depression as Assessed by Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: baseline ,Week 12 (LOCF)
measure: 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)
timeFrame: baseline, week 12 (LOCF)
measure: Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Mania Score
timeFrame: baseline, week 12 (LOCF)
measure: Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Depression Scale
timeFrame: baseline, week 12 (LOCF)
measure: Change From Baseline to Week 12 (LOCF) in the SDS Total Score
timeFrame: baseline, week 12 (LOCF)
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research
state: Alabama
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Los Angeles
country: United States
facility: AXIS Clinical Trials
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc
state: California
city: Palo Alto
country: United States
facility: Stanford University School of Medicine Research Program VA Palo Alto Health Care System
state: California
city: San Francisco
country: United States
facility: SF-Care, Inc.
state: California
city: Santa Ana
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Bradenton
country: United States
facility: Florida Clinical Research LLC
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions Inc.
state: Florida
city: Miami Springs
country: United States
facility: Galiz Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Terre Haute
country: United States
facility: Clinco
state: Indiana
city: Haverhill
country: United States
facility: Activ Med Practices & Research
state: Massachusetts
city: St. Louis
country: United States
facility: Psych Care Consultants Research
state: Missouri
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Garlield Heights
country: United States
facility: Charak Clincial Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Lincoln
country: United States
facility: Lincoln Research
state: Rhode Island
city: Charleston
country: United States
facility: Carolina Clinical Trials
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions Inc.
state: Tennessee
city: Dallas
country: United States
facility: Psychoneuroendocrinology Research Group, Dept of Psychiatry, UT Southwestern Medical Center
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: Buenos Aires
country: Argentina
facility: Clinica Privada de Salud Mental Santa Teresa de Avila
city: Buenos Aires
country: Argentina
facility: Novain Neurociencias Group
city: Buenos Aires
country: Argentina
facility: Instituto Nacional de Psicopatología (INAPSI)
city: Buenos Aires
country: Argentina
facility: Fundacion para el estudio y tratamiento de las enfermedades mentales (FETEM)
city: Cordoba
country: Argentina
facility: Instituto DAMIC SRL
city: Rosario
country: Argentina
facility: Centro de Investigacion y Asistencia en Psiquiatria (CIAP)
city: Rousse
country: Bulgaria
facility: Center for Mental Health
city: Sofia
country: Bulgaria
facility: Multiprofiled Hospital for Active Treatment "Alexandrovska"
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Santiago
country: Chile
facility: Hospital El Pino
city: Santiago
country: Chile
facility: Clinica Pedro Montt
city: Brno - mesto
country: Czech Republic
facility: Saint Anne, s.r.o., Psychiatricke oddeleni
city: Havirov
country: Czech Republic
facility: Psychiatricka ambulance
city: Pisek
country: Czech Republic
facility: Psychiatricka lecebna U Honzicka
city: Prague
country: Czech Republic
facility: Psychiatricka ambulance
city: Praha
country: Czech Republic
facility: Clintrial s.r.o.
city: Praha
country: Czech Republic
facility: Psychiatricka ambulance
city: Praha
country: Czech Republic
facility: Psychiatricka ambulance Prosek
city: Prerov
country: Czech Republic
facility: Telemens, s.r.o.
city: Dijon cedex
country: France
facility: CHS La Chartreuse - Pôle 6
city: Dole
country: France
facility: Centre Hospitalier Spécialisé du Jura - Centre Médico Psychiatrique
city: Nimes
country: France
facility: Centre Hospitalier Régional Universitaire
city: Budapest
country: Hungary
facility: Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika
city: Budapest
country: Hungary
facility: Nyiro Gyula Korhaz, I. Pszichiatria
city: Budapest
country: Hungary
facility: Nyiro Gyula Korhaz, II. Pszichiatria
city: Budapest
country: Hungary
facility: Nyiro Gyula Korhaz
city: Sapporo-shi
country: Japan
facility: Goryokai Medical Corporation
state: Hokkaido
city: Sakai
country: Japan
facility: Asakayama General Hospital
state: Osaka
city: Kumamoto
country: Japan
facility: Yuge Hospital
city: Tokyo
country: Japan
facility: Nishigahara Hospital
city: Toyama
country: Japan
facility: Kawada Hospital
city: Gdynia
country: Poland
facility: NZOZ Syntonia
city: Kielce
country: Poland
facility: NZOZ BioMed
city: Tuszyn
country: Poland
facility: NZOZ Prywatna Klinika Psychiatryczna Inventiva
city: Izhevsk
country: Russian Federation
facility: State Healthcare and Forensic Psychiatric Expertise Institution
city: Novgorod
country: Russian Federation
facility: Nizhny Novgorod Regional State Institution of Healthcare
city: St Petersburg
country: Russian Federation
facility: St Petersburg State Government Healthcare Institution
city: St. Petersburg
country: Russian Federation
facility: Saint Petersburg State Healthcare Institution "City psycho-neurology Dispanser #7"
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Healthcare Institution "City Clinical Hospital #4"
city: Tomsk
country: Russian Federation
facility: Mental Health Research Institute of Siberian Branch of RAMS
city: Belgrade
country: Serbia
facility: Clinical Hospital Centre Dragisa Misovic
city: Kragujevac
country: Serbia
facility: Clinical Centre Kragujevac, Psychiatric Hospital
city: Nis
country: Serbia
facility: Clinic for Mental Health Protection, Clinical Centre Nis
city: Novi Knezevac
country: Serbia
facility: Specialized Hospital for Psychiatric Diseased "Sveti Vracevi"
city: Rimavska Sobota
country: Slovakia
facility: Psychiatricke oddelenie, Vseobecna nemocnica Rimavska Sobota NaP n.o.
city: Zlate Moravce
country: Slovakia
facility: Psychiatricka ambulancia
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Lurasidone Medical Director, MD
role: STUDY_DIRECTOR
References: