Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)
NCT ID: NCT00868699
Last Updated: 2014-04-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
505 participants
INTERVENTIONAL
2009-04-30
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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lurasidone low arm
lurasidone
lurasidone 20 mg/day for Days 1-7
Placebo
Placebo
Placebo Comparator
lurasidone high arm
lurasidone
lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
Interventions
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lurasidone
lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
lurasidone
lurasidone 20 mg/day for Days 1-7
Placebo
Placebo Comparator
Eligibility Criteria
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Inclusion Criteria
* Subject must have a lifetime history of at least one bipolar manic or mixed episode
Exclusion Criteria
* Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization
* Imminent risk of suicide or injury to self, others, or property
18 Years
75 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director, MD
Role: STUDY_DIRECTOR
Sumitomo Pharma America, Inc.
Locations
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Synergy Escondido,710 East Grand Ave.
Escondido, California, United States
Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3
Garden Grove, California, United States
Excell Research, Inc,3998 Vista Way,Suite 100
Oceanside, California, United States
University of California at Irvine Medical Center
Orange, California, United States
California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road
Pico Rivera, California, United States
California Neuropsychopharmacology Clinical Research Institute, LLC,466 26th Street,6th Floor
San Diego, California, United States
University of Colorado
Aurora, Colorado, United States
Florida Clinical Research Center, LLC,3914 State Road 64 East
Bradenton, Florida, United States
Florida Clinical Research Center, LLC,2300 Maitland Center Parkway,Suite 230
Maitland, Florida, United States
Depression and Anxiety Disorders Research Institute
Tampa, Florida, United States
Janus Center for Psychiatric Research,5601 Corporate Way,Suite 103
West Palm Beach, Florida, United States
American Medical Research Inc.,1200 Harger Road Suite 415
Oak Brook, Illinois, United States
Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340
Lake Charles, Louisiana, United States
Sheppard Pratt Health System,6501 North Charles Street
Baltimore, Maryland, United States
Albuquerque Neuroscience Inc., 101 Hospital Loop, NE, Suite 209
Albuquerque, New Mexico, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Richard H. Weisler., M.D., P.A., & Associates,700 Spring Forest Road,Suite 125
Raleigh, North Carolina, United States
Mood Disorders Program-UHCMC
Cleveland, Ohio, United States
MetroHealth System
Cleveland, Ohio, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, United States
FutureSearch Clinical Trials, LLC.,4200 Marathon Blvd.,Suite 200
Austin, Texas, United States
Medical Services Prague s.r.o.
Kolejni 429-5, Prague, Czechia
Psychiatricka ambulance
Brno - Mesto, , Czechia
BIALBI s.r.o., Psychiatricke Oddeleni
Litoměřice, , Czechia
Clintrial, 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
Samvedna Hospitals
Ahmedabad, Gujarat, India
Seth K M School of P G Medicine & Research
Ahmedabad, Gujarat, India
Mental Illness Treatment Rehabilitationi Foundation
Ahmedabad, Gujarat, India
Spandana Nursing Home
Bangalore, Karna, India
Sujata Birla Hospital & Research Centre
Nashik, Mahara, India
R.K. Yadav Memorial Mental Health & De-Addiction Hospital
Jaipur, Rajasthan, India
Manobal Med. Research Centre
Lucknow, Uttar Prad, India
Spitalul Clinic de Urgenta Militar Central
Bucdresti, , 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
Spitalul Clinic de Neurologie si Psihiatrie Oradea
Oradea, , Romania
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
Cape Trial Centre
Cape Town, W. Cape, , South Africa
Paarl Medical Centre
Paarl, W. Cape, , South Africa
Clinika
Port Elizabeth, E. Cape, , South Africa
Dey Clinic
Pretoria, Gauteng, , South Africa
Vereeniging Medi-Clinic
Vereeniging, Free State, , South Africa
Chair of Psychiatry and Medical Psychology
Donetsk, Donetsk Oblast, Ukraine
Reg. Psychiatric Hospital
Odesa, , Ukraine
Reg Cl.Ps.H.n.a.O.F. Malstev, Fem.Ac. Gen. Ps.D.5B
Poltava, , Ukraine
CRI Cl.Psych.Hosp. #1, Fem. Psych. Dept. #2, Male I
Simferopol, , Ukraine
Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21
Vinnitsia, , Ukraine
Countries
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References
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Loebel A, Cucchiaro J, Silva R, Kroger H, Hsu J, Sarma K, Sachs G. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb;171(2):160-8. doi: 10.1176/appi.ajp.2013.13070984.
Goldberg JF, Siu C, Tocco M, Pikalov A, Loebel A. The Effect of Lurasidone on Anxiety Symptoms in Patients With Bipolar Depression: A Post Hoc Analysis. J Clin Psychiatry. 2023 Jun 7;84(4):22m14732. doi: 10.4088/JCP.22m14732.
Raison CL, Pikalov A, Siu C, Tsai J, Koblan K, Loebel A. C-reactive protein and response to lurasidone in patients with bipolar depression. Brain Behav Immun. 2018 Oct;73:717-724. doi: 10.1016/j.bbi.2018.08.009. Epub 2018 Aug 10.
Sajatovic M, Forester BP, Tsai J, Kroger H, Pikalov A, Cucchiaro J, Loebel A. Efficacy of Lurasidone in Adults Aged 55 Years and Older With Bipolar Depression: Post Hoc Analysis of 2 Double-Blind, Placebo-Controlled Studies. J Clin Psychiatry. 2016 Oct;77(10):e1324-e1331. doi: 10.4088/JCP.15m10261.
Rajagopalan K, Bacci ED, Ng-Mak D, Wyrwich K, Pikalov A, Loebel A. Effects on health-related quality of life in patients treated with lurasidone for bipolar depression: results from two placebo controlled bipolar depression trials. BMC Psychiatry. 2016 May 23;16:157. doi: 10.1186/s12888-016-0865-y.
Chapel S, Chiu YY, Hsu J, Cucchiaro J, Loebel A. Lurasidone Dose Response in Bipolar Depression: A Population Dose-response Analysis. Clin Ther. 2016 Jan 1;38(1):4-15. doi: 10.1016/j.clinthera.2015.11.013. Epub 2015 Dec 22.
Loebel A, Siu C, Rajagopalan K, Pikalov A, Cucchiaro J, Ketter TA. Recovery in bipolar depression: Post-hoc analysis of a placebo-controlled lurasidone trial followed by a long-term continuation study. J Affect Disord. 2015 Nov 1;186:376-82. doi: 10.1016/j.jad.2015.07.033. Epub 2015 Aug 5.
McIntyre RS, Cucchiaro J, Pikalov A, Kroger H, Loebel A. Lurasidone in the treatment of bipolar depression with mixed (subsyndromal hypomanic) features: post hoc analysis of a randomized placebo-controlled trial. J Clin Psychiatry. 2015 Apr;76(4):398-405. doi: 10.4088/JCP.14m09410.
Other Identifiers
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EUDRACT No. 2008-007457-13
Identifier Type: -
Identifier Source: secondary_id
D1050236
Identifier Type: -
Identifier Source: org_study_id
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