Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)
NCT ID: NCT00868452
Last Updated: 2014-04-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
348 participants
INTERVENTIONAL
2009-04-30
2012-01-31
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
lurasidone + (lithium or divalproex)
lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
Placebo
Placebo + (lithium or divalproex)
20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
Interventions
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lurasidone + (lithium or divalproex)
lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
Placebo + (lithium or divalproex)
20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
Eligibility Criteria
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Inclusion Criteria
* Subject must have a lifetime history of at least one bipolar manic or mixed episode
* Subject must be taking lithium or divalproex at least 28 days prior to screening
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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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
Synergy Escondido
Escondido, California, United States
Collaborative Neuroscience Network Inc.,12772 Valley View Street
Garden Grove, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California at Irvine Medical Center
Orange, California, United States
CNRI - Los Angeles LLC,8309 Telegraph Road
Pico Rivera, California, United States
CNRI - San Diego, LLC
San Diego, California, United States
Stanford University School of Medicine
Stanford, California, United States
University of Colorado
Aurora, Colorado, United States
Depression and Anxiety Disorders Research Institue
Tampa, Florida, United States
American Medical Research Inc.,1200 Harger Road Suite 415
Oak Brook, Illinois, United States
American Medical Research, Inc., 1200 Harger Road Suite 415
Oak Brook, Illinois, United States
J. Gary Booker, MD
Shreveport, Louisiana, United States
Sheppard Pratt Health System,6501 North Charles Street
Baltimore, Maryland, United States
Capital Clinical Research,5515 Security Lane, Suite 525
Rockville, Maryland, United States
Midwest Research Group
Saint Charles, Missouri, United States
Albuquerque Neuroscience Inc.,101 Hospital Loop, Suite 209
Albuquerque, New Mexico, United States
Lake Charles Clinical Trials LLC,700 Spring Forest Road
Raleigh, North Carolina, United States
Richard H. Weisler , M.D., PA.,& Associates, 700 Spring Forest Road, Suite 125
Raleigh, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Mood Disorders Program-UHCMC
Cleveland, Ohio, United States
MetroHealth System
Cleveland, Ohio, United States
Midwest Clinical research Center, One Elizabeth Place, Suite G-3
Dayton, Ohio, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, United States
FutureSearch Clinical Trials, LLC., 4200 Marathon Blvd., Suite 200
Austin, Texas, United States
Psychiatricka ambulance
Brno - Mesto, , Czechia
BIALBI s.r.o. Psychiatricke oddeleni
Litoměřice, , Czechia
Clintrial, s.r.o.
Prague, , Czechia
Medical Services Prague s.r.o.
Prague, , Czechia
Psychiatricka ambulance Prosek
Prague, , Czechia
Hopital Caremeau, Service de Psychiatrie A
Nîmes, , France
Zans Ritter, Marcel
Orvault, , France
Jana Thomsen
Berlin BE, , Germany
SV Medical College
Tirupati, Andh Prad, India
Vijayawada Institute of Mental Health and Neurosciences, Psychiatry
Vijaywada, Andh Prad, India
Samvedna Hospitals
Ahmedabad, Gujarat, India
Sheth Vadilal Sarabhai General Hospital
Ahmedabad, Gujarat, India
Mental Illness Treatment Rehabilitation Foundation (MITR)
Ahmedabad, Gujarat, India
Shree Hatkesh Health Foundation
Jūnāgadh, Gujarat, India
Spandana Nursing Home
Bangalore, Karna, India
Sujata Birla Hospital & Research Centre
Nashik, Mahara, India
Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry
Delhi, National Capital Territory of Delhi, India
R.K. Yadav Memorial Mental Health & De-Addiction Hospital
Jaipur, Rajasthan, India
Manobal Med. Research Centre
Lucknow, Uttar Prad, India
ZOZ Poradnia Zdrowia Psychicznego
Chełmno, , Poland
Praktyka Lekarska Sensorium S.M.O.
Skorzewo, , Poland
Wojewodzki Szpital Brodnowski SP ZOZ
Warsaw, , Poland
Spitalul Clinic de Urgenta Militar Central "Prof. Dr. Carol" Psihiatrie
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
Spitalul Clinic de Neurologie si Psihiatrie Oradea
Oradea, , Romania
Spitalul Judetean de Urgenta Pitesti Sectia de Psihiatric
Piteşti, , Romania
Russian State Medical University
Moscow, , Russia
Moscow Medical Academy named 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
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
Reg. Clinic Psych. Hosp., Dept 11, DNMU n.a.M. Gorkiy
Donetsk, , Ukraine
Odesa Regional Psychoneurological Dispensary
Odesa, , Ukraine
Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM
Poltava, , Ukraine
CRI"Cl. Psych.Hosp.#1, Fem Psych.Dept.#2, Male Psych.Dept.#1
Simferopol, , Ukraine
Reg. Psych. Hosp. n.a. O.Yuschenko, Dept. #21, VNMUn.a.M. Pirog
Vinnitsia, , Ukraine
Countries
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References
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Loebel A, Cucchiaro J, Silva R, Kroger H, Sarma K, Xu J, Calabrese JR. Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb;171(2):169-77. doi: 10.1176/appi.ajp.2013.13070985.
Tocco M, Mao Y. Efficacy and Safety of Adding Lurasidone to Ongoing Therapy With Lithium or Valproate for the Treatment of an Acute Bipolar Depressive Episode: A Post Hoc Analysis of 2 Placebo-Controlled Trials. J Clin Psychopharmacol. 2024 Jul-Aug 01;44(4):345-352. doi: 10.1097/JCP.0000000000001850. Epub 2024 Apr 19.
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.
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.
Other Identifiers
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EUDRACT No. 2008-007482-23
Identifier Type: -
Identifier Source: secondary_id
D1050235
Identifier Type: -
Identifier Source: org_study_id
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