Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
A 24-Week, Flexible-Dose, Open-Label Extension Study of Lurasidone for the Treatment of Bipolar I Depression
2 other identifiers
interventional
817
15 countries
151
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2009
Typical duration for phase_3
151 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2009
CompletedFirst Posted
Study publicly available on registry
March 25, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
April 1, 2014
CompletedApril 14, 2016
March 1, 2016
3.8 years
March 23, 2009
February 17, 2014
March 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment
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)
24 weeks
Secondary Outcomes (2)
Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
24 weeks
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
Study Arms (1)
lurasidone
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (151)
Woodland International Research Inc
Little Rock, Arkansas, 72211, United States
South Coast Clinical Trials Inc.
Anaheim, California, 92804, United States
Catalina Research Institute
Chino, California, 91710, United States
Clinical Innovations Inc.
Costa Mesa, California, 92626, United States
Synergy Escondido
Escondido, California, 92025, United States
Collaborative Neuroscience Network Inc
Garden Grove, California, 92645, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Florida Clinical Research Center LLC
Maitland, California, 32751, United States
Excell Research, Inc
Oceanside, California, 92056, United States
University of California at Irvine Medical Center
Orange, California, 92868, United States
CNRI - Los Angeles LLC
Pico Rivera, California, 90660, United States
Clinical Innovations Inc.
Riverside, California, 92506, United States
California Neuropsychopharmacology Clinical Research Instit
San Diego, California, 92102, United States
Artemis Institute for Clinical Research LLC
San Diego, California, 92123, United States
Sharp Mesa Vista Hospital
San Diego, California, 92123, United States
Clinical Innovations Inc.
Santa Ana, California, 92705, United States
Stanford University School of Medicine
Stanford, California, 94305, United States
Collaborative Neuroscience Network Inc.
Torrance, California, 90502, United States
University of Colorado
Aurora, Colorado, 80045, United States
MCB Clinical Research Centers-Colorado Springs
Colorado Springs, Colorado, 80917, United States
Florida Clinical Research Center LLC
Bradenton, Florida, 34208, United States
Florida Clinical Research Center LLC
Fruitland Park, Florida, 34731, United States
Accurate Clinical Trials
Kissimmee, Florida, 34741, United States
Clinical Neuroscience Solutions INc.
Orlando, Florida, 32806, United States
University of South Florida Institute - Tampa
Tampa, Florida, 33613, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407, United States
Northwest Behavioral Research Center
Rosewekk, Georgia, 30076, United States
Institute for Behavioral Medicine LLC
Smyrna, Georgia, 30080, United States
American Medical Research
Oak Brook, Illinois, 60523, United States
Lake Charles Clinical Trials LLC
Lake Charles, Louisiana, 70601, United States
Booker, J. Gary, MD. APMC
Shreveport, Louisiana, 71104, United States
Sheppard Pratt Health System
Baltimore, Maryland, 21285, United States
Capitol Clinical Research
Rockville, Maryland, 20852, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
Midwest Research Group
Saint Charles, Missouri, 63301, United States
CRI Worldwide, LLC
Willingboro, New Jersey, 08046, United States
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, 87109, United States
Social Psychiatry Research Institute
Brooklyn, New York, 11235, United States
Neurobehavioral Research, Inc
Cedarhurst, New York, United States
Village Clinical Research Inc.
New York, New York, 10003, United States
Medical & Behavioral Health Research PC
New York, New York, 10023, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Zarzar Psychiatric Associates PLLC
Raleigh, North Carolina, 27607, United States
Richard H. Weisler & Associates
Raleigh, North Carolina, 27609, United States
Quest Therapeutics
Avon Lake, Ohio, 44012, United States
Psychiatric Professional Services Inc
Cincinnati, Ohio, 45267, United States
Mood Disorders Program-UHCMC
Cleveland, Ohio, 44106, United States
MetroHealth System
Cleveland, Ohio, 44122, United States
Midwest Clinical Research Center
Dayton, Ohio, 45408, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, 97210, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, 38119, United States
FutureSearch Clinical Trials LP
Austin, Texas, 78756, United States
FutureSearch Trials
Dallas, Texas, 75231, United States
Pillar Clinical Research LLC
Dallas, Texas, 75243, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090, United States
Wharton Research Center
Wharton, Texas, 77488, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, 98104, United States
Clinical Research Group Edmonton
Edmonton, Alberta, T6L 6W6, Canada
Okanagan Clinical Trials
Kelowna, British Columbia, V1Y 2H4, Canada
Pierre-Janet Hospital
Gatineau, Quebec, J9A 1K7, Canada
Hopital Louis-H Lafontaine
Montreal, Quebec, H1N 3M5, 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, 602 00, Czechia
BIALBI s.r.o. Psychiatricke oddeleni
Litoměřice, 412 01, Czechia
Psychiatricka ambulance Prosek
Lovosicka, Czechia
Vojenska nemocnice Olomouc
Olomouc, 779 00, Czechia
Clintrial, s.r.o.
Prague, 10 100 00, Czechia
Psychiatry Trial s.r.o.
Prague, 158 00, Czechia
Medical Services Prague s.r.o.
Prague, 6 160 00, Czechia
Hopital Caremeau, Service de Psychiatrie A
Nîmes, 30 30029, France
Zans Ritter, Marcel
Orvault, 44700, France
S V Medical College
Tirupati, Andh Prad, 517507, India
Vijayawada Institute of Mental Health and Neurosciences, Psychiatry
Vijaywada, Andh Prad, 520002, India
Brain Mind Behaviour Neurosciences Research Institute
Visakhapatnam, Andh Prad, 530002, India
Seth K M School of P G Medicine & Research
Ahmedabad, Gujarat, 380006, India
Mental Illness Treatment Rehabilitation Foundation (MITR)
Ahmedabad, Gujarat, 380013, India
Brij Psychiatry Hospital & Muskaan Research Centre
Vadodara, Gujarat, 390001, India
Spandana Nursing Home
Bangalore, Karna, 560010, India
Abhava Hospital
Bangalore, Karna, 560027, India
K.S. Hegde Medical Academy
Mangalore, Karna, 575018, India
Shanti Nursing Home
Aurangabad, Mahara, 431001, India
Poona Hospital & Research Center
Pune, Mahara, 411 030, India
Mahatma Gandhi Institute of Medical Sciences
Wardha, Mahara, 442001, India
Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry
Delhi, National Capital Territory of Delhi, 110092, India
Dr. Tambi's Neuropsychiatry Center
Jaipur, Rajaasthan, 302017, India
R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry
Jaipur, Rajasthan, 302021, India
Mahendru Psychiatric Centre
Kanpur, Uttar Prad, 208005, India
Manobal Med. Research Centre
Lucknow, Uttar Prad, 226006, India
Shree Hatkesh Health Foundation
Gujarat, 362002, India
Samvedna Hospitals
Gujarat, 380006, India
Chhatrapati Shahuji Maharaj
Lucknow, 22603, India
Sujata Dirla Hospital & Research Centre
Mahara, 422101, India
Ongata Hospital
Hachioji-shi, 192-0153, Japan
Kohnodai Hp., National Center for Global Health and Medicine
Ichikawa-sha, 272-8516, Japan
NHO Hizen Psychiatric Center
Kanzaki-gun, 842-0192, Japan
National Center of Neurology and Psychiatry
Kodaira-shi, 187-8551, Japan
Asakayama General Hospital
Sakaishi, 590-0018, Japan
Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital
Takatsuki-shi, 569-1041, Japan
Neuromeda, JSC
Kaunas, 50185, Lithuania
Kaunas Hospital Division Marui Hospital, Public Institution
Kaunas, 53136, Lithuania
Silutes Mental Health and Psychotherapy Center, JSC
Šilutė, 99142, Lithuania
Seskines Outpatient Clinic, Public Institution
Vilnius, 07156, Lithuania
Zirmunai Mental Health Center, Public Institution
Vilnius, 09112, Lithuania
Hospital Nacional Hipolito Unanue
Lima, 10, Peru
Hospital Nacional Arzobispo Loayza
Lima, 1, Peru
Clinica Vesalio
Lima, 41, Peru
ZOZ Poradnia Zdrowia Psychicznego
Chełmno, 86-200, Poland
Praktyka Lekarska Sensorium S.M.O.
Skorzewo, 60-185, Poland
Spitalul Clinic de Urgenta Militar Central
Bucharest, 010825, Romania
Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia
Bucharest, 041914, Romania
Spitalul Clinic Judetean de Urgenta Cluj
Cluj-Napoca, 400012, Romania
Spitalul Clinic de Neuropsihiatrie Craiova
Craiova, 200620, Romania
Centrul de Recuperare si Reabilitare Gura Ocnitei
Gura Ocniței, 130083, Romania
Spitalul Clinic de Neurologie si Psihiatrie Oradea
Oradea, 410154, Romania
Russian State Medical University of RosZdrav
Moscow, 117997, Russia
Moscow Medical Academy name I.M. Sechenov
Moscow, 11935, Russia
City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
Saint Petersburg, 190121, Russia
Bekhterev Scientific Research Psychoneurological Institute
Saint Petersburg, 193019, Russia
Psychoneurology Dispensary #4
Saint Petersburg, 197110, Russia
LLC International Medical Centre "SOGAZ"
Saint Petersburg, 198035, Russia
Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach Psychiatricke oddelenie
Bojnice, 92701, Slovakia
Psychiatricka ambulancia Mentum, s.r.o.
Bratislava, 82007, Slovakia
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov Psychiatricka klinika
Bratislava, 82606, Slovakia
Nemocnica s poliklinikou Liptovsky Mikulas Psychiatricke oddelenie
Liptovský Mikuláš, 03123, Slovakia
PsychoLine s.r.o. Psychiatricka ambulancia
Rimavská Sobota, 97901, Slovakia
Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie
Rožňava, 048 01, Slovakia
Centrum zdravia R. B.K. s.r.o. Psychiatricka ambulancia
Svidník, 08901, Slovakia
Pro mente sana s.r.o. Psychiaricka ambulancia
Trenčín, 91101, Slovakia
Groote Schuur Hospital
Cape Town, 7925, South Africa
Cape Trial Centre
Cape Town, W. Cape, 7530, South Africa
Paarl Medical Centre
Paarl, W. Cape, 7646, South Africa
Clinika, Murray and Roberts Building
Port Elizabeth, 6000, South Africa
Dey Clinic
Pretoria, Gauteng, 0181, South Africa
Vereeniging Medi-Clinic
Vereeniging, Free State, 1941, South Africa
Regional Clinical Hospital n.a.l.l.
Dnipropetrovsk, 49005, Ukraine
Com. Inst. "Dnipropetrovsk Reg. Cl. Psych. Hosp." DSMA
Dnipropetrovsk, 49115, Ukraine
Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy
Donetsk, 83037, Ukraine
St.In."Inst. of Neurol., Psych. and Narcol. of the AMSU"
Kharkiv, 61068, Ukraine
Kherson Regional Psychiatric Hospital
Kherson, 73488, Ukraine
Kyiv City Psychoneurological Hospital #2
Kviv, 02660, Ukraine
Lviv Reg.St.Cl.Psych.Hosp.Dept.#20, LNMU n.a.D. Halytskiy Chair of Psychiatry, Psychology and Sexololgy
Lviv, 79021, Ukraine
Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1
Odesa, 65006, Ukraine
Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM
Poltava, 36006, Ukraine
Crimean republican Clinical Psychiatric Hospital
Simferopol, Ukraine
Ternopil Regional Municipal Dispensary, Narcology Dept., Ch. of Neurol. Psych. Narcol. & Med. Psychol.
Ternopil, 46020, Ukraine
Reg. Psych. Hosp.n.a. O.Yuschenko, Dept. #121 VNMI
Vinnitsia, 21018, Ukraine
Zapor Reg. Cl. Hosp., Zaporizhzhia SMU, ENT Dept.
Zaporizhzhia, 69032, Ukraine
Related Publications (1)
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.
PMID: 29146409DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director, CNS
- Organization
- Sunovion
Study Officials
- STUDY DIRECTOR
Medical Director, MD
Sumitomo Pharma America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2009
First Posted
March 25, 2009
Study Start
April 1, 2009
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
April 14, 2016
Results First Posted
April 1, 2014
Record last verified: 2016-03