Clinical trial NCT00868959: Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
Official title: A 24-Week, Flexible-Dose, Open-Label Extension Study of Lurasidone for the Treatment of Bipolar I Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Depression
Keywords: Bipolar
Depression
Lurasidone
Latuda
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-25
Enrollment: 817
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression


Eligibility criteria: Inclusion Criteria:

* Subject is judged by the investigator to be suitable for participation in a 24-week clinical trial involving open-label lurasidone treatment
* Subject has completed the 6-week treatment period and all required assessments on the final study visit (Day 42, Visit 8) of either Study D1050235, NCT#00868452 or Study D1050236, NCT#008668699.

Exclusion Criteria:

* Imminent risk of suicide, injury to self or to others, or damage to property
* Subject has evidence of severe movement disorders.
* Subject tests positive for drugs of abuse (at Visit 8 in Study D1050235, NCT#00868452 or D1050236, NCT#008688699).

Primary outcomes:
measure: Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment
timeFrame: 24 weeks
Secondary outcomes:
measure: Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: 24 weeks
measure: Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International Research Inc
state: Arkansas
city: Anaheim
country: United States
facility: South Coast Clinical Trials Inc.
state: California
city: Chino
country: United States
facility: Catalina Research Institute
state: California
city: Costa Mesa
country: United States
facility: Clinical Innovations Inc.
state: California
city: Escondido
country: United States
facility: Synergy Escondido
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network Inc
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Maitland
country: United States
facility: Florida Clinical Research Center LLC
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc
state: California
city: Orange
country: United States
facility: University of California at Irvine Medical Center
state: California
city: Pico Rivera
country: United States
facility: CNRI - Los Angeles LLC
state: California
city: Riverside
country: United States
facility: Clinical Innovations Inc.
state: California
city: San Diego
country: United States
facility: California Neuropsychopharmacology Clinical Research Instit
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research LLC
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: Santa Ana
country: United States
facility: Clinical Innovations Inc.
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Network Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers-Colorado Springs
state: Colorado
city: Bradenton
country: United States
facility: Florida Clinical Research Center LLC
state: Florida
city: Fruitland park
country: United States
facility: Florida Clinical Research Center LLC
state: Florida
city: Kissimmee
country: United States
facility: Accurate Clinical Trials
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions INc.
state: Florida
city: Tampa
country: United States
facility: University of South Florida Institute - Tampa
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center for Psychiatric Research
state: Florida
city: Rosewekk
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Smyrna
country: United States
facility: Institute for Behavioral Medicine LLC
state: Georgia
city: Oak Brook
country: United States
facility: American Medical Research
state: Illinois
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials LLC
state: Louisiana
city: Shreveport
country: United States
facility: Booker, J. Gary, MD. APMC
state: Louisiana
city: Baltimore
country: United States
facility: Sheppard Pratt Health System
state: Maryland
city: Rockville
country: United States
facility: Capitol Clinical Research
state: Maryland
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: St. Charles
country: United States
facility: Midwest Research Group
state: Missouri
city: Willingboro
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience Inc.
state: New Mexico
city: Brooklyn
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc
state: New York
city: New York
country: United States
facility: Village Clinical Research Inc.
state: New York
city: New York
country: United States
facility: Medical & Behavioral Health Research PC
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Raleigh
country: United States
facility: Zarzar Psychiatric Associates PLLC
state: North Carolina
city: Raleigh
country: United States
facility: Richard H. Weisler & Associates
state: North Carolina
city: Avon Lake
country: United States
facility: Quest Therapeutics
state: Ohio
city: Cincinnati
country: United States
facility: Psychiatric Professional Services Inc
state: Ohio
city: Cleveland
country: United States
facility: Mood Disorders Program-UHCMC
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth System
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Portland
country: United States
facility: Summit Research Network (Oregon) Inc.
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions Inc.
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Clinical Trials LP
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials
state: Texas
city: Dallas
country: United States
facility: Pillar Clinical Research LLC
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, PA
state: Texas
city: Wharton
country: United States
facility: Wharton Research Center
state: Texas
city: Seattle
country: United States
facility: Summit Research Network (Seattle) LLC
state: Washington
city: Edmonton
country: Canada
facility: Clinical Research Group Edmonton
state: Alberta
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials
state: British Columbia
city: Gatineau
country: Canada
facility: Pierre-Janet Hospital
state: Quebec
city: Montreal
country: Canada
facility: Hopital Louis-H Lafontaine
state: Quebec
city: Barranquilla
country: Colombia
facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations
city: Bello
country: Colombia
facility: E.S.E. Hospital Mental de Antioquia
city: Bogota
country: Colombia
facility: Centro de Investigacion y Atencion para la Salud Mental
city: Bogota
country: Colombia
facility: Centro de Investigaciones del Sistema Nerviosa Limitada-Gr
city: Brno - mesto
country: Czech Republic
facility: Saint Anne, s.r.o., Psychiatricke oddeleni
city: Litomerice
country: Czech Republic
facility: BIALBI s.r.o. Psychiatricke oddeleni
city: Lovosicka
country: Czech Republic
facility: Psychiatricka ambulance Prosek
city: Olomouc
country: Czech Republic
facility: Vojenska nemocnice Olomouc
city: Praha
country: Czech Republic
facility: Clintrial, s.r.o.
city: Praha
country: Czech Republic
facility: Psychiatry Trial s.r.o.
city: Praha
country: Czech Republic
facility: Medical Services Prague s.r.o.
city: Nimes Cedex
country: France
facility: Hopital Caremeau, Service de Psychiatrie A
city: Orvault
country: France
facility: Zans Ritter, Marcel
city: Tirupati
country: India
facility: S V Medical College
state: Andh Prad
city: Vijaywada
country: India
facility: Vijayawada Institute of Mental Health and Neurosciences, Psychiatry
state: Andh Prad
city: Vishakhapatnam
country: India
facility: Brain Mind Behaviour Neurosciences Research Institute
state: Andh Prad
city: Ahmedabad
country: India
facility: Seth K M School of P G Medicine & Research
state: Gujarat
city: Ahmedabad
country: India
facility: Mental Illness Treatment Rehabilitation Foundation (MITR)
state: Gujarat
city: Vadodara
country: India
facility: Brij Psychiatry Hospital & Muskaan Research Centre
state: Gujarat
city: Bangalore
country: India
facility: Spandana Nursing Home
state: Karna
city: Bangalore
country: India
facility: Abhava Hospital
state: Karna
city: Mangalore
country: India
facility: K.S. Hegde Medical Academy
state: Karna
city: Aurangabad
country: India
facility: Shanti Nursing Home
state: Mahara
city: Pune
country: India
facility: Poona Hospital & Research Center
state: Mahara
city: Wardha
country: India
facility: Mahatma Gandhi Institute of Medical Sciences
state: Mahara
city: Jaipur
country: India
facility: Dr. Tambi's Neuropsychiatry Center
state: Rajaasthan
city: Jaipur
country: India
facility: R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry
state: Rajasthan
city: Kanpur
country: India
facility: Mahendru Psychiatric Centre
state: Uttar Prad
city: Lucknow
country: India
facility: Manobal Med. Research Centre
state: Uttar Prad
city: Delhi
country: India
facility: Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry
city: Gujarat
country: India
facility: Shree Hatkesh Health Foundation
city: Gujarat
country: India
facility: Samvedna Hospitals
city: Lucknow
country: India
facility: Chhatrapati Shahuji Maharaj
city: Mahara
country: India
facility: Sujata Dirla Hospital & Research Centre
city: Hachioji-shi
country: Japan
facility: Ongata Hospital
city: Ichikawa-sha
country: Japan
facility: Kohnodai Hp., National Center for Global Health and Medicine
city: Kanzaki-gun
country: Japan
facility: NHO Hizen Psychiatric Center
city: Kodaira-shi
country: Japan
facility: National Center of Neurology and Psychiatry
city: Sakai-shi
country: Japan
facility: Asakayama General Hospital
city: Takatsuki-shi
country: Japan
facility: Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital
city: Kaunas
country: Lithuania
facility: Neuromeda, JSC
city: Kaunas
country: Lithuania
facility: Kaunas Hospital Division Marui Hospital, Public Institution
city: Silute
country: Lithuania
facility: Silutes Mental Health and Psychotherapy Center, JSC
city: Vilnius
country: Lithuania
facility: Seskines Outpatient Clinic, Public Institution
city: Vilnius
country: Lithuania
facility: Zirmunai Mental Health Center, Public Institution
city: Lima
country: Peru
facility: Hospital Nacional Hipolito Unanue
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza
city: Lima
country: Peru
facility: Clinica Vesalio
city: Chelmno
country: Poland
facility: ZOZ Poradnia Zdrowia Psychicznego
city: Skorzewo
country: Poland
facility: Praktyka Lekarska Sensorium S.M.O.
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Urgenta Militar Central
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj
city: Craiova
country: Romania
facility: Spitalul Clinic de Neuropsihiatrie Craiova
city: Gura Ocnitei
country: Romania
facility: Centrul de Recuperare si Reabilitare Gura Ocnitei
city: Oradea
country: Romania
facility: Spitalul Clinic de Neurologie si Psihiatrie Oradea
city: Moscow
country: Russian Federation
facility: Russian State Medical University of RosZdrav
city: Moscow
country: Russian Federation
facility: Moscow Medical Academy name I.M. Sechenov
city: St. Petersburg
country: Russian Federation
facility: City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
city: St. Petersburg
country: Russian Federation
facility: Bekhterev Scientific Research Psychoneurological Institute
city: St. Petersburg
country: Russian Federation
facility: Psychoneurology Dispensary #4
city: St. Petersburg
country: Russian Federation
facility: LLC International Medical Centre "SOGAZ"
city: Bojnice
country: Slovakia
facility: Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach Psychiatricke oddelenie
city: Bratislava
country: Slovakia
facility: Psychiatricka ambulancia Mentum, s.r.o.
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov Psychiatricka klinika
city: Liptovsky Mikulas
country: Slovakia
facility: Nemocnica s poliklinikou Liptovsky Mikulas Psychiatricke oddelenie
city: Rimavska Sobota
country: Slovakia
facility: PsychoLine s.r.o. Psychiatricka ambulancia
city: Roznava
country: Slovakia
facility: Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie
city: Svidnik
country: Slovakia
facility: Centrum zdravia R. B.K. s.r.o. Psychiatricka ambulancia
city: Trencin
country: Slovakia
facility: Pro mente sana s.r.o. Psychiaricka ambulancia
city: Cape Town, W. Cape
country: South Africa
facility: Cape Trial Centre
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
city: Paarl, W. Cape
country: South Africa
facility: Paarl Medical Centre
city: Port Elizabeth
country: South Africa
facility: Clinika, Murray and Roberts Building
city: Pretoria, Gauteng
country: South Africa
facility: Dey Clinic
city: Vereeniging, Free State
country: South Africa
facility: Vereeniging Medi-Clinic
city: Dnipropetrovsk
country: Ukraine
facility: Regional Clinical Hospital n.a.l.l.
city: Dnipropetrovsk
country: Ukraine
facility: Com. Inst. "Dnipropetrovsk Reg. Cl. Psych. Hosp." DSMA
city: Donetsk
country: Ukraine
facility: Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy
city: Kharkiv
country: Ukraine
facility: St.In."Inst. of Neurol., Psych. and Narcol. of the AMSU"
city: Kherson
country: Ukraine
facility: Kherson Regional Psychiatric Hospital
city: Kviv
country: Ukraine
facility: Kyiv City Psychoneurological Hospital #2
city: Lviv
country: Ukraine
facility: Lviv Reg.St.Cl.Psych.Hosp.Dept.#20, LNMU n.a.D. Halytskiy Chair of Psychiatry, Psychology and Sexololgy
city: Odessa
country: Ukraine
facility: Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1
city: Poltava
country: Ukraine
facility: Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM
city: Simferopol
country: Ukraine
facility: Crimean republican Clinical Psychiatric Hospital
city: Ternopil
country: Ukraine
facility: Ternopil Regional Municipal Dispensary, Narcology Dept., Ch. of Neurol. Psych. Narcol. & Med. Psychol.
city: Vinnitsia
country: Ukraine
facility: Reg. Psych. Hosp.n.a. O.Yuschenko, Dept. #121 VNMI
city: Zaporizhzhia
country: Ukraine
facility: Zapor Reg. Cl. Hosp., Zaporizhzhia SMU, ENT Dept.
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: Forester BP, Sajatovic M, Tsai J, Pikalov A, Cucchiaro J, Loebel A. Safety and Effectiveness of Long-Term Treatment with Lurasidone in Older Adults with Bipolar Depression: Post-Hoc Analysis of a 6-Month, Open-Label Study. Am J Geriatr Psychiatry. 2018 Feb;26(2):150-159. doi: 10.1016/j.jagp.2017.08.013. Epub 2017 Oct 10.