Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex
NCT ID: NCT01358357
Last Updated: 2016-09-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
965 participants
INTERVENTIONAL
2011-06-30
2015-04-30
Brief Summary
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This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Lurasidone 20-80 mg flexible dose
Lurasidone
Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
Placebo
Placebo
20-80 mg flexible dose
Interventions
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Lurasidone
Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
Placebo
20-80 mg flexible dose
Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
* Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision (DSM-IV-TR) diagnosis of bipolar I disorder
•≥ 1 manic, mixed manic, or depressed episode in past 2 years
* YMRS or MADRS total score ≥ 14 if on lithium or divalproex; ≥ 18 if not on lithium or divalproex
Double-blind Phase
* Subjects must achieve consistent clinical stability, defined as total scores ≤ 12 on the YMRS and MADRS over at least 12 weeks, with the allowance of two excursions (YMRS and/or MADRS total scores up to 13 or 14, respectively) except during the last 4 weeks before randomization
Exclusion Criteria
* Diagnosis of an Axis I or Axis II disorder, other than bipolar I disorder, that is the primary focus of treatment within 3 months of screening
* Subjects for whom diagnostic agreement between the Investigator and United BioSource Corporation (Boston) (UBC) cannot be reached
* Ultra-fast rapid cycling (defined as ≥ 8 mood episodes over the previous 12-month period)
* Subjects who test positive for drugs of abuse at screening. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to abstain from cannabis during the study
* Unstable/inadequately treated medical illness
* The subjects answers "yes" to "Suicidal Ideation" items 4 or 5 on the C-SSRS (at time of evaluation)
Double Blind Phase
* Subjects who in the Investigator's judgment have not been compliant with study medication during the stabilization phase
* Subjects who have not stabilized during the open-label phase (within 20 weeks)
* Subjects who test positive for drugs of abuse at double-blind phase baseline. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to abstain from cannabis during the study
18 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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Harmonex Neuroscience Research
Dothan, Alabama, United States
Behavioral Research Specialists, LLC
Glendale, California, United States
AXIS Clinical Trials
Los Angeles, California, United States
Excell Research, Inc.
Oceanside, California, United States
Stanford University School of Medicine Research Program VA Palo Alto Health Care System
Palo Alto, California, United States
SF-CARE, Inc.
San Francisco, California, United States
Neuropsychiatric Research Center of Orange County
Santa Ana, California, United States
"Stanford University School of Medicine
Stanford, California, United States
Florida Clinical Research LLC
Bradenton, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Galiz Research
Miami Springs, Florida, United States
Clinical Neuroscience Solutions
Orlando, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Clinco
Terre Haute, Indiana, United States
ActivMed Practices & Research Inc.
Haverhill, Massachusetts, United States
Psych Care Consultants Research
St Louis, Missouri, United States
Village Clinical Research Inc,
New York, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Charak Center for Health and Wellness
Garfield Heights, Ohio, United States
Cutting Edge Research Groupd
Oklahoma City, Oklahoma, United States
Suburban Research Associates
Media, Pennsylvania, United States
Lincoln Research
Lincoln, Rhode Island, United States
Carolina Clinical Trials, Inc.
Charleston, South Carolina, United States
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, United States
Psychoneuroendocrinology Research Group, Dept of Psychiatry, UT Southwestern Medical Center
Dallas, Texas, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States
Sanatorio Morra
Córdoba, Córdoba Province, Argentina
Centro de Atencion E Invest. Clinica (CAICI)
Rosario, Santa Fe Province, Argentina
Novain Neurociencias Group
Buenos Aires, , Argentina
Centro de Neuropsiquiatria
Buenos Aires, , Argentina
IPEM-Instituto de Prevención de las Enfermedades Mentales.
Buenos Aires, , Argentina
Instituto DAMCI
Córdoba, , Argentina
Clinica Privada de Salud Mental Santa Teresa de Avila
La Plata, , Argentina
Centro de Psiquiatria Biologica
Mendoza, , Argentina
The Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
RWF Medic Pty Ltd as Trustee for Farnbach Family Trust at Neurotherapy Victoria
Malvern, Victoria, Australia
The Melbourne Clinic
Richmond, Victoria, Australia
Hollywood Medical Centre
Fremantle, Western Australia, Australia
Psychiatry Dispensary
Burgas, , Bulgaria
University Multiprofiled Hospital for Active Treatment "Sveti Georgi"
Plovdiv, , Bulgaria
Regional Psychiatric Dispensary
Rousse, , Bulgaria
Multiprofiled Hospital for Active Treatment "Alexandrovska"
Sofia, , Bulgaria
Psychiatric Clinic, Military Medical Academy
Sofia, , Bulgaria
Multprofiled Hospital for Active Treatment "Sveta Marina"
Varna, , Bulgaria
CETEP
Santiago, , Chile
Clinica Las Condes
Santiago, , Chile
Psicomedica
Santiago, , Chile
Clinic Hospital Centre Rijeka Clinic for Psychiatry
Rijeka, , Croatia
Clinical Hospital Centre Zagreb
Zagreb, , Croatia
Klinicki Bolnicki Centar Zagreb-Rebro
Zagreb, , Croatia
University Hospital Sestremilosrdnice
Zagreb, , Croatia
University Hospital Centre Zagreb
Zagreg, , Croatia
Saint Anne s.r.o.
Brno, , Czechia
Fakultni Nemocnice Brno
Brno-Bohunice, , Czechia
Psychiatricka ambulance
Havířov, , Czechia
Psychiatricka Iecebna U Honzicka
Písek, , Czechia
Clintrial s.r.o.
Prague, , Czechia
Psychiatricka Ambulance
Prague, , Czechia
Psychiaricka ambulance
Prague, , Czechia
Psychiatricka ambulance Prosek
Prague, , Czechia
Psychiatricke Centrum Praha
Prague 8-Bohunice, , Czechia
Psychosocialni Centrum
Přerov, , Czechia
Psychiatricka ambulance
Ústí nad Labem, , Czechia
CHS La Chartreuse-Pole 6
Dijon, , France
Centre Hospitalier Specialise du Jura-Centre Medico Psychiatrique
Dole, , France
Hopital Lapeyronie
Montpellier, , France
CHRU de Nimes, Service de Psychiatrie adulte
Nîmes, , France
Obudai Egeszsegugyi Centurm Kft.
Budapest, , Hungary
Fovarosi Onkormanyzat Szent Istvan Korhaz es Szent Laszlo Korhaz
Budapest, , Hungary
Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika
Budapest, , Hungary
Nyiro Gyula Korhaz
Budapest, , Hungary
Fovarosi Onkormanyzat Nyiro Gyula Korhaz, I. Pszichiatria
Budapest, , Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, , Hungary
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaz
Gyula, , Hungary
Haruna Hospital
Shibukawa, Gunma, Japan
Goryokai Medical Corporation
Sapporo, Hokkaido, Japan
Sapporokousetsu Hospital
Sapporo, Hokkaido, Japan
Nagano Prefectural Mental Wellness Center-Komagane
Komagane, Nagano, Japan
Shonan Hospital
Matsumoto-shi, Nagano, Japan
Asakayama General Hospital
Sakai, Osaka, Japan
National Hospital Organization Hizen Psychiatric Center
Kanzaki, Saga-ken, Japan
Nishigahara Hospital
Kita-ku, Tokyo, Japan
Okehazama Hospital Fujita Kokoro Care Center
Aichi, , Japan
Ongata Hospital
Hachioji, Tokyo, , Japan
Yuge Hospital
Kumamoto, , Japan
Arakaki Hospital
Okinawa, , Japan
Kawada Hospital
Toyama, , Japan
NZOZ Syntonia
Gdynia, , Poland
NZOZ BioMed
Kielce, , Poland
Wojewodzki Osrodek Lexznictwa Psychiatrycznego w Toruniu
Torun, , Poland
Prywatny Gabinet Lekarski Jaroslaw Strzelec
Tuszyn, , Poland
Przychodnia Lekarsko-Psychologiczna "Persona" Spolka Partnerska Lekarzy
Wroclaw, , Poland
State Healthcare and Forensic Psychiatric Expertise Institution
Izhevsk, , Russia
Nizhny Novgorod Regional State Institution of Healthcare
Nizhny Novgorod, , Russia
St. Petersburg State Healthcare Institution (SPSHI)
Saint Petersburg, , Russia
St.Petersburg State Healthcare Institution (SPSHI)
Saint Petersburg, , Russia
St Petersburg State Government Healthcare Institution
Saint Petersburg, , Russia
Mental Health Research Institute of Rams
Tomsk, , Russia
Clinical Centre of Serbia
Belgrade, , Serbia
Clinical Hospital Centre Dragisa Misovic
Belgrade, , Serbia
Psychiatric Clinic Clinical Center Kragujevac
Kragujevac, , Serbia
Clinical Centre Nis
Niš, , Serbia
Specialized Hospital for Psychiatric Diseased "Sveti Vracevi"
Novi Kneževac, , Serbia
Vseobecna Nemocnica Rimavska Sobota, NaP, n.o. Bratislava
Rimavská Sobota, , Slovakia
Psychiatricka ambulancia
Zlaté Moravce, , Slovakia
Countries
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Other Identifiers
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2011-000986-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D1050296
Identifier Type: -
Identifier Source: org_study_id
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