Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
- Registration Number
- NCT00868959
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 817
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description lurasidone lurasidone -
- Primary Outcome Measures
Name Time Method Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment 24 weeks Rate of treatment-emergent adverse events in subjects who have completed (ie, reached 6-week endpoint) of Study D1050235 (NCT00868452), Study D1050236 (NCT00868699) or Study D1050292 (NCT01284517)
- Secondary Outcome Measures
Name Time Method 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) 24 weeks This CGI-BP-S is a clinician-rated assessment of the subjects current severity of depression and ranges from 1="Normal, not ill" to 7="Very severly ill". Higher scores are associated with greater severity.
Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score 24 weeks The MADRS is a clinician-rated assessment of the subject's level of depression. Ten items are rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of ten items: reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
Trial Locations
- Locations (147)
Clinical Innovations Inc.
🇺🇸Santa Ana, California, United States
Accurate Clinical Trials
🇺🇸Kissimmee, Florida, United States
Sheppard Pratt Health System
🇺🇸Baltimore, Maryland, United States
CNRI - Los Angeles LLC
🇺🇸Pico Rivera, California, United States
FutureSearch Trials
🇺🇸Dallas, Texas, United States
Mood Disorders Program-UHCMC
🇺🇸Cleveland, Ohio, United States
Zarzar Psychiatric Associates PLLC
🇺🇸Raleigh, North Carolina, United States
Stanford University School of Medicine
🇺🇸Stanford, California, United States
Woodland International Research Inc
🇺🇸Little Rock, Arkansas, United States
MetroHealth System
🇺🇸Cleveland, Ohio, United States
FutureSearch Clinical Trials LP
🇺🇸Austin, Texas, United States
Institute for Behavioral Medicine LLC
🇺🇸Smyrna, Georgia, United States
Neurobehavioral Research, Inc
🇺🇸Cedarhurst, New York, United States
Summit Research Network (Oregon) Inc.
🇺🇸Portland, Oregon, United States
Clinical Research Group Edmonton
🇨🇦Edmonton, Alberta, Canada
Quest Therapeutics
🇺🇸Avon Lake, Ohio, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
South Coast Clinical Trials Inc.
🇺🇸Anaheim, California, United States
Wharton Research Center
🇺🇸Wharton, Texas, United States
Janus Center for Psychiatric Research
🇺🇸West Palm Beach, Florida, United States
Collaborative Neuroscience Network Inc.
🇺🇸Torrance, California, United States
Social Psychiatry Research Institute
🇺🇸Brooklyn, New York, United States
Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations
🇨🇴Barranquilla, Colombia
Pillar Clinical Research LLC
🇺🇸Dallas, Texas, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Hopital Louis-H Lafontaine
🇨🇦Montreal, Quebec, Canada
Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital
🇯🇵Takatsuki-shi, Japan
E.S.E. Hospital Mental de Antioquia
🇨🇴Bello, Colombia
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Clinical Neuroscience Solutions Inc.
🇺🇸Memphis, Tennessee, United States
Asakayama General Hospital
🇯🇵Sakai-shi, Japan
Richard H. Weisler & Associates
🇺🇸Raleigh, North Carolina, United States
Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy
🇺🇦Donetsk, Ukraine
Crimean republican Clinical Psychiatric Hospital
🇺🇦Simferopol, Ukraine
Reg. Psych. Hosp.n.a. O.Yuschenko, Dept. #121 VNMI
🇺🇦Vinnitsia, Ukraine
Moscow Medical Academy name I.M. Sechenov
🇷🇺Moscow, Russian Federation
National Center of Neurology and Psychiatry
🇯🇵Kodaira-shi, Japan
Psychoneurology Dispensary #4
🇷🇺St. Petersburg, Russian Federation
Dey Clinic
🇿🇦Pretoria, Gauteng, South Africa
Zans Ritter, Marcel
🇫🇷Orvault, France
Hopital Caremeau, Service de Psychiatrie A
🇫🇷Nimes Cedex, France
Praktyka Lekarska Sensorium S.M.O.
🇵🇱Skorzewo, Poland
Ongata Hospital
🇯🇵Hachioji-shi, Japan
NHO Hizen Psychiatric Center
🇯🇵Kanzaki-gun, Japan
Bekhterev Scientific Research Psychoneurological Institute
🇷🇺St. Petersburg, Russian Federation
LLC International Medical Centre "SOGAZ"
🇷🇺St. Petersburg, Russian Federation
Russian State Medical University of RosZdrav
🇷🇺Moscow, Russian Federation
Mental Illness Treatment Rehabilitation Foundation (MITR)
🇮🇳Ahmedabad, Gujarat, India
Kyiv City Psychoneurological Hospital #2
🇺🇦Kviv, Ukraine
Ternopil Regional Municipal Dispensary, Narcology Dept., Ch. of Neurol. Psych. Narcol. & Med. Psychol.
🇺🇦Ternopil, Ukraine
Shree Hatkesh Health Foundation
🇮🇳Gujarat, India
Zirmunai Mental Health Center, Public Institution
🇱🇹Vilnius, Lithuania
St.In."Inst. of Neurol., Psych. and Narcol. of the AMSU"
🇺🇦Kharkiv, Ukraine
Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1
🇺🇦Odessa, Ukraine
Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM
🇺🇦Poltava, Ukraine
ZOZ Poradnia Zdrowia Psychicznego
🇵🇱Chelmno, Poland
Clinika, Murray and Roberts Building
🇿🇦Port Elizabeth, South Africa
Kherson Regional Psychiatric Hospital
🇺🇦Kherson, Ukraine
Lviv Reg.St.Cl.Psych.Hosp.Dept.#20, LNMU n.a.D. Halytskiy Chair of Psychiatry, Psychology and Sexololgy
🇺🇦Lviv, Ukraine
Zapor Reg. Cl. Hosp., Zaporizhzhia SMU, ENT Dept.
🇺🇦Zaporizhzhia, Ukraine
Vereeniging Medi-Clinic
🇿🇦Vereeniging, Free State, South Africa
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
Psychiatric Professional Services Inc
🇺🇸Cincinnati, Ohio, United States
Red Oak Psychiatry Associates, PA
🇺🇸Houston, Texas, United States
Summit Research Network (Seattle) LLC
🇺🇸Seattle, Washington, United States
R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry
🇮🇳Jaipur, Rajasthan, India
Brain Mind Behaviour Neurosciences Research Institute
🇮🇳Vishakhapatnam, Andh Prad, India
K.S. Hegde Medical Academy
🇮🇳Mangalore, Karna, India
Shanti Nursing Home
🇮🇳Aurangabad, Mahara, India
Manobal Med. Research Centre
🇮🇳Lucknow, Uttar Prad, India
Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry
🇮🇳Delhi, India
Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie
🇸🇰Roznava, Slovakia
Centrum zdravia R. B.K. s.r.o. Psychiatricka ambulancia
🇸🇰Svidnik, Slovakia
Clintrial, s.r.o.
🇨🇿Praha, Czech Republic
Dr. Tambi's Neuropsychiatry Center
🇮🇳Jaipur, Rajaasthan, India
BIALBI s.r.o. Psychiatricke oddeleni
🇨🇿Litomerice, Czech Republic
Psychiatricka ambulance Prosek
🇨🇿Lovosicka, Czech Republic
Spandana Nursing Home
🇮🇳Bangalore, Karna, India
Poona Hospital & Research Center
🇮🇳Pune, Mahara, India
Seth K M School of P G Medicine & Research
🇮🇳Ahmedabad, Gujarat, India
Saint Anne, s.r.o., Psychiatricke oddeleni
🇨🇿Brno - mesto, Czech Republic
Mahendru Psychiatric Centre
🇮🇳Kanpur, Uttar Prad, India
Centro de Investigacion y Atencion para la Salud Mental
🇨🇴Bogota, Colombia
Centro de Investigaciones del Sistema Nerviosa Limitada-Gr
🇨🇴Bogota, Colombia
Vijayawada Institute of Mental Health and Neurosciences, Psychiatry
🇮🇳Vijaywada, Andh Prad, India
Abhava Hospital
🇮🇳Bangalore, Karna, India
Sujata Dirla Hospital & Research Centre
🇮🇳Mahara, India
Hospital Nacional Hipolito Unanue
🇵🇪Lima, Peru
Clinica Vesalio
🇵🇪Lima, Peru
Spitalul Clinic Judetean de Urgenta Cluj
🇷🇴Cluj-Napoca, Romania
Mahatma Gandhi Institute of Medical Sciences
🇮🇳Wardha, Mahara, India
Samvedna Hospitals
🇮🇳Gujarat, India
Neuromeda, JSC
🇱🇹Kaunas, Lithuania
Pro mente sana s.r.o. Psychiaricka ambulancia
🇸🇰Trencin, Slovakia
Chhatrapati Shahuji Maharaj
🇮🇳Lucknow, India
Kaunas Hospital Division Marui Hospital, Public Institution
🇱🇹Kaunas, Lithuania
Silutes Mental Health and Psychotherapy Center, JSC
🇱🇹Silute, Lithuania
Seskines Outpatient Clinic, Public Institution
🇱🇹Vilnius, Lithuania
Hospital Nacional Arzobispo Loayza
🇵🇪Lima, Peru
Spitalul Clinic de Neuropsihiatrie Craiova
🇷🇴Craiova, Romania
Centrul de Recuperare si Reabilitare Gura Ocnitei
🇷🇴Gura Ocnitei, Romania
Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach Psychiatricke oddelenie
🇸🇰Bojnice, Slovakia
Psychiatricka ambulancia Mentum, s.r.o.
🇸🇰Bratislava, Slovakia
Spitalul Clinic de Neurologie si Psihiatrie Oradea
🇷🇴Oradea, Romania
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov Psychiatricka klinika
🇸🇰Bratislava, Slovakia
PsychoLine s.r.o. Psychiatricka ambulancia
🇸🇰Rimavska Sobota, Slovakia
Village Clinical Research Inc.
🇺🇸New York, New York, United States
Medical & Behavioral Health Research PC
🇺🇸New York, New York, United States
Catalina Research Institute
🇺🇸Chino, California, United States
Synergy Escondido
🇺🇸Escondido, California, United States
Collaborative Neuroscience Network Inc
🇺🇸Garden Grove, California, United States
Excell Research, Inc
🇺🇸Oceanside, California, United States
Florida Clinical Research Center LLC
🇺🇸Fruitland park, Florida, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of California at Irvine Medical Center
🇺🇸Orange, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
MCB Clinical Research Centers-Colorado Springs
🇺🇸Colorado Springs, Colorado, United States
Clinical Neuroscience Solutions INc.
🇺🇸Orlando, Florida, United States
Booker, J. Gary, MD. APMC
🇺🇸Shreveport, Louisiana, United States
American Medical Research
🇺🇸Oak Brook, Illinois, United States
University of South Florida Institute - Tampa
🇺🇸Tampa, Florida, United States
Northwest Behavioral Research Center
🇺🇸Rosewekk, Georgia, United States
Lake Charles Clinical Trials LLC
🇺🇸Lake Charles, Louisiana, United States
Albuquerque Neuroscience Inc.
🇺🇸Albuquerque, New Mexico, United States
Midwest Research Group
🇺🇸St. Charles, Missouri, United States
Capitol Clinical Research
🇺🇸Rockville, Maryland, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
CRI Worldwide, LLC
🇺🇸Willingboro, New Jersey, United States
Okanagan Clinical Trials
🇨🇦Kelowna, British Columbia, Canada
Pierre-Janet Hospital
🇨🇦Gatineau, Quebec, Canada
Vojenska nemocnice Olomouc
🇨🇿Olomouc, Czech Republic
Psychiatry Trial s.r.o.
🇨🇿Praha, Czech Republic
S V Medical College
🇮🇳Tirupati, Andh Prad, India
Medical Services Prague s.r.o.
🇨🇿Praha, Czech Republic
Kohnodai Hp., National Center for Global Health and Medicine
🇯🇵Ichikawa-sha, Japan
Spitalul Clinic de Urgenta Militar Central
🇷🇴Bucuresti, Romania
Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia
🇷🇴Bucuresti, Romania
City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
🇷🇺St. Petersburg, Russian Federation
Nemocnica s poliklinikou Liptovsky Mikulas Psychiatricke oddelenie
🇸🇰Liptovsky Mikulas, Slovakia
Cape Trial Centre
🇿🇦Cape Town, W. Cape, South Africa
Groote Schuur Hospital
🇿🇦Cape Town, South Africa
Paarl Medical Centre
🇿🇦Paarl, W. Cape, South Africa
Regional Clinical Hospital n.a.l.l.
🇺🇦Dnipropetrovsk, Ukraine
Com. Inst. "Dnipropetrovsk Reg. Cl. Psych. Hosp." DSMA
🇺🇦Dnipropetrovsk, Ukraine
Brij Psychiatry Hospital & Muskaan Research Centre
🇮🇳Vadodara, Gujarat, India