Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
NCT ID: NCT00868959
Last Updated: 2016-04-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
817 participants
INTERVENTIONAL
2009-04-30
2013-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)
NCT00868699
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)
NCT00868452
A Study of Lurasidone Compared With Placebo for the Treatment of Bipolar I Depression
NCT04383691
Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
NCT01284517
Biosignatures of Latuda for Bipolar Depression
NCT02239094
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
lurasidone
lurasidone
Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
lurasidone
Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director, MD
Role: STUDY_DIRECTOR
Sumitomo Pharma America, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Woodland International Research Inc
Little Rock, Arkansas, United States
South Coast Clinical Trials Inc.
Anaheim, California, United States
Catalina Research Institute
Chino, California, United States
Clinical Innovations Inc.
Costa Mesa, California, United States
Synergy Escondido
Escondido, California, United States
Collaborative Neuroscience Network Inc
Garden Grove, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Florida Clinical Research Center LLC
Maitland, California, United States
Excell Research, Inc
Oceanside, California, United States
University of California at Irvine Medical Center
Orange, California, United States
CNRI - Los Angeles LLC
Pico Rivera, California, United States
Clinical Innovations Inc.
Riverside, California, United States
California Neuropsychopharmacology Clinical Research Instit
San Diego, California, United States
Artemis Institute for Clinical Research LLC
San Diego, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
Clinical Innovations Inc.
Santa Ana, California, United States
Stanford University School of Medicine
Stanford, California, United States
Collaborative Neuroscience Network Inc.
Torrance, California, United States
University of Colorado
Aurora, Colorado, United States
MCB Clinical Research Centers-Colorado Springs
Colorado Springs, Colorado, United States
Florida Clinical Research Center LLC
Bradenton, Florida, United States
Florida Clinical Research Center LLC
Fruitland Park, Florida, United States
Accurate Clinical Trials
Kissimmee, Florida, United States
Clinical Neuroscience Solutions INc.
Orlando, Florida, United States
University of South Florida Institute - Tampa
Tampa, Florida, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, United States
Northwest Behavioral Research Center
Rosewekk, Georgia, United States
Institute for Behavioral Medicine LLC
Smyrna, Georgia, United States
American Medical Research
Oak Brook, Illinois, United States
Lake Charles Clinical Trials LLC
Lake Charles, Louisiana, United States
Booker, J. Gary, MD. APMC
Shreveport, Louisiana, United States
Sheppard Pratt Health System
Baltimore, Maryland, United States
Capitol Clinical Research
Rockville, Maryland, United States
Precise Research Centers
Flowood, Mississippi, United States
Midwest Research Group
Saint Charles, Missouri, United States
CRI Worldwide, LLC
Willingboro, New Jersey, United States
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, United States
Social Psychiatry Research Institute
Brooklyn, New York, United States
Neurobehavioral Research, Inc
Cedarhurst, New York, United States
Village Clinical Research Inc.
New York, New York, United States
Medical & Behavioral Health Research PC
New York, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Zarzar Psychiatric Associates PLLC
Raleigh, North Carolina, United States
Richard H. Weisler & Associates
Raleigh, North Carolina, United States
Quest Therapeutics
Avon Lake, Ohio, United States
Psychiatric Professional Services Inc
Cincinnati, Ohio, United States
Mood Disorders Program-UHCMC
Cleveland, Ohio, United States
MetroHealth System
Cleveland, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, United States
FutureSearch Clinical Trials LP
Austin, Texas, United States
FutureSearch Trials
Dallas, Texas, United States
Pillar Clinical Research LLC
Dallas, Texas, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, United States
Wharton Research Center
Wharton, Texas, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, United States
Clinical Research Group Edmonton
Edmonton, Alberta, Canada
Okanagan Clinical Trials
Kelowna, British Columbia, Canada
Pierre-Janet Hospital
Gatineau, Quebec, Canada
Hopital Louis-H Lafontaine
Montreal, Quebec, Canada
Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations
Barranquilla, , Colombia
E.S.E. Hospital Mental de Antioquia
Bello, , Colombia
Centro de Investigacion y Atencion para la Salud Mental
Bogotá, , Colombia
Centro de Investigaciones del Sistema Nerviosa Limitada-Gr
Bogotá, , Colombia
Saint Anne, s.r.o., Psychiatricke oddeleni
Brno - Mesto, , Czechia
BIALBI s.r.o. Psychiatricke oddeleni
Litoměřice, , Czechia
Psychiatricka ambulance Prosek
Lovosicka, , Czechia
Vojenska nemocnice Olomouc
Olomouc, , Czechia
Clintrial, s.r.o.
Prague, , Czechia
Psychiatry Trial s.r.o.
Prague, , Czechia
Medical Services Prague s.r.o.
Prague, , Czechia
Hopital Caremeau, Service de Psychiatrie A
Nîmes, , France
Zans Ritter, Marcel
Orvault, , France
S V Medical College
Tirupati, Andh Prad, India
Vijayawada Institute of Mental Health and Neurosciences, Psychiatry
Vijaywada, Andh Prad, India
Brain Mind Behaviour Neurosciences Research Institute
Visakhapatnam, Andh Prad, India
Seth K M School of P G Medicine & Research
Ahmedabad, Gujarat, India
Mental Illness Treatment Rehabilitation Foundation (MITR)
Ahmedabad, Gujarat, India
Brij Psychiatry Hospital & Muskaan Research Centre
Vadodara, Gujarat, India
Spandana Nursing Home
Bangalore, Karna, India
Abhava Hospital
Bangalore, Karna, India
K.S. Hegde Medical Academy
Mangalore, Karna, India
Shanti Nursing Home
Aurangabad, Mahara, India
Poona Hospital & Research Center
Pune, Mahara, India
Mahatma Gandhi Institute of Medical Sciences
Wardha, Mahara, India
Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry
Delhi, National Capital Territory of Delhi, India
Dr. Tambi's Neuropsychiatry Center
Jaipur, Rajaasthan, India
R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry
Jaipur, Rajasthan, India
Mahendru Psychiatric Centre
Kanpur, Uttar Prad, India
Manobal Med. Research Centre
Lucknow, Uttar Prad, India
Shree Hatkesh Health Foundation
Gujarat, , India
Samvedna Hospitals
Gujarat, , India
Chhatrapati Shahuji Maharaj
Lucknow, , India
Sujata Dirla Hospital & Research Centre
Mahara, , India
Ongata Hospital
Hachioji-shi, , Japan
Kohnodai Hp., National Center for Global Health and Medicine
Ichikawa-sha, , Japan
NHO Hizen Psychiatric Center
Kanzaki-gun, , Japan
National Center of Neurology and Psychiatry
Kodaira-shi, , Japan
Asakayama General Hospital
Sakaishi, , Japan
Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital
Takatsuki-shi, , Japan
Neuromeda, JSC
Kaunas, , Lithuania
Kaunas Hospital Division Marui Hospital, Public Institution
Kaunas, , Lithuania
Silutes Mental Health and Psychotherapy Center, JSC
Šilutė, , Lithuania
Seskines Outpatient Clinic, Public Institution
Vilnius, , Lithuania
Zirmunai Mental Health Center, Public Institution
Vilnius, , Lithuania
Hospital Nacional Hipolito Unanue
Lima, , Peru
Hospital Nacional Arzobispo Loayza
Lima, , Peru
Clinica Vesalio
Lima, , Peru
ZOZ Poradnia Zdrowia Psychicznego
Chełmno, , Poland
Praktyka Lekarska Sensorium S.M.O.
Skorzewo, , Poland
Spitalul Clinic de Urgenta Militar Central
Bucharest, , Romania
Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Cluj
Cluj-Napoca, , Romania
Spitalul Clinic de Neuropsihiatrie Craiova
Craiova, , Romania
Centrul de Recuperare si Reabilitare Gura Ocnitei
Gura Ocniței, , Romania
Spitalul Clinic de Neurologie si Psihiatrie Oradea
Oradea, , Romania
Russian State Medical University of RosZdrav
Moscow, , Russia
Moscow Medical Academy name I.M. Sechenov
Moscow, , Russia
City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
Saint Petersburg, , Russia
Bekhterev Scientific Research Psychoneurological Institute
Saint Petersburg, , Russia
Psychoneurology Dispensary #4
Saint Petersburg, , Russia
LLC International Medical Centre "SOGAZ"
Saint Petersburg, , Russia
Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach Psychiatricke oddelenie
Bojnice, , Slovakia
Psychiatricka ambulancia Mentum, s.r.o.
Bratislava, , Slovakia
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov Psychiatricka klinika
Bratislava, , Slovakia
Nemocnica s poliklinikou Liptovsky Mikulas Psychiatricke oddelenie
Liptovský Mikuláš, , Slovakia
PsychoLine s.r.o. Psychiatricka ambulancia
Rimavská Sobota, , Slovakia
Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie
Rožňava, , Slovakia
Centrum zdravia R. B.K. s.r.o. Psychiatricka ambulancia
Svidník, , Slovakia
Pro mente sana s.r.o. Psychiaricka ambulancia
Trenčín, , Slovakia
Groote Schuur Hospital
Cape Town, , South Africa
Cape Trial Centre
Cape Town, W. Cape, , South Africa
Paarl Medical Centre
Paarl, W. Cape, , South Africa
Clinika, Murray and Roberts Building
Port Elizabeth, , South Africa
Dey Clinic
Pretoria, Gauteng, , South Africa
Vereeniging Medi-Clinic
Vereeniging, Free State, , South Africa
Regional Clinical Hospital n.a.l.l.
Dnipropetrovsk, , Ukraine
Com. Inst. "Dnipropetrovsk Reg. Cl. Psych. Hosp." DSMA
Dnipropetrovsk, , Ukraine
Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy
Donetsk, , Ukraine
St.In."Inst. of Neurol., Psych. and Narcol. of the AMSU"
Kharkiv, , Ukraine
Kherson Regional Psychiatric Hospital
Kherson, , Ukraine
Kyiv City Psychoneurological Hospital #2
Kviv, , Ukraine
Lviv Reg.St.Cl.Psych.Hosp.Dept.#20, LNMU n.a.D. Halytskiy Chair of Psychiatry, Psychology and Sexololgy
Lviv, , Ukraine
Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1
Odesa, , Ukraine
Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM
Poltava, , Ukraine
Crimean republican Clinical Psychiatric Hospital
Simferopol, , Ukraine
Ternopil Regional Municipal Dispensary, Narcology Dept., Ch. of Neurol. Psych. Narcol. & Med. Psychol.
Ternopil, , Ukraine
Reg. Psych. Hosp.n.a. O.Yuschenko, Dept. #121 VNMI
Vinnitsia, , Ukraine
Zapor Reg. Cl. Hosp., Zaporizhzhia SMU, ENT Dept.
Zaporizhzhia, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EUDRACT No. 2008-007483-42
Identifier Type: -
Identifier Source: secondary_id
D1050256
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.