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

PHASE3CompletedINTERVENTIONAL
Enrollment

377

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

July 31, 2015

Study Completion Date

July 31, 2015

Conditions
Bipolar I Disorder
Interventions
DRUG

Lurasidone

Lurasidone 20-80 mg taken orally once daily

Trial Locations (71)

1125

Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika, Budapest

1135

Nyiro Gyula Korhaz, I. Pszichiatria, Budapest

Nyiro Gyula Korhaz, II. Pszichiatria, Budapest

Nyiro Gyula Korhaz, Budapest

1431

"Multiprofiled Hospital for Active Treatment Alexandrovska", Sofia

1606

Military Medical Academy, Sofia

1900

Clinica Privada de Salud Mental Santa Teresa de Avila, Buenos Aires

2000

Centro de Investigacion y Asistencia en Psiquiatria (CIAP), Rosario

5003

Instituto DAMIC SRL, Córdoba

7003

Center for Mental Health, Rousse

11000

Clinical Hospital Centre Dragisa Misovic, Belgrade

14618

Finger Lakes Clinical Research, Rochester

18000

Clinic for Mental Health Protection, Clinical Centre Nis, Niš

19063

Suburban Research Associates, Media

21033

CHS La Chartreuse - Pôle 6, Dijon

23330

"Specialized Hospital for Psychiatric Diseased Sveti Vracevi", Novi Kneževac

29407

Carolina Clinical Trials, Charleston

30308

Atlanta Center for Medical Research, Atlanta

30900

Centre Hospitalier Régional Universitaire, Nîmes

32216

Clinical Neuroscience Solutions Inc., Jacksonville

32806

Clinical Neuroscience Solutions, Orlando

33166

Galiz Research, Miami Springs

34000

Clinical Centre Kragujevac, Psychiatric Hospital, Kragujevac

34201

Florida Clinical Research LLC, Bradenton

36303

Harmonex Neuroscience Research, Dothan

38119

Clinical Neuroscience Solutions Inc., Memphis

39100

Centre Hospitalier Spécialisé du Jura - Centre Médico Psychiatrique, Dole

44125

Charak Clincial Research Center, Garlield Heights

47802

Clinco, Terre Haute

63128

Psych Care Consultants Research, St Louis

73116

Cutting Edge Research Group, Oklahoma City

73601

Psychiatricka ambulance, Havířov

75235

Psychoneuroendocrinology Research Group, Dept of Psychiatry, UT Southwestern Medical Center, Dallas

77566

R/D Clinical Research, Inc., Lake Jackson

90036

AXIS Clinical Trials, Los Angeles

91206

Behavioral Research Specialists, LLC, Glendale

92056

Excell Research, Inc, Oceanside

92701

Neuropsychiatric Research Center of Orange County, Santa Ana

93404

Stanford University School of Medicine Research Program VA Palo Alto Health Care System, Palo Alto

93405

Stanford University School of Medicine, Stanford

94117

SF-Care, Inc., San Francisco

95301

Psychiatricka ambulancia, Zlaté Moravce

97912

Psychiatricke oddelenie, Vseobecna nemocnica Rimavska Sobota NaP n.o., Rimavská Sobota

190005

"Saint Petersburg State Healthcare Institution City psycho-neurology Dispanser #7", Saint Petersburg

190121

St Petersburg State Government Healthcare Institution, Saint Petersburg

191119

"St. Petersburg State Healthcare Institution City Clinical Hospital #4", Saint Petersburg

426054

State Healthcare and Forensic Psychiatric Expertise Institution, Izhevsk

603155

Nizhny Novgorod Regional State Institution of Healthcare, Veliky Novgorod

634014

Mental Health Research Institute of Siberian Branch of RAMS, Tomsk

8053095

Hospital El Pino, Santiago

8330838

Clinica Pedro Montt, Santiago

08130

Activ Med Practices & Research, Haverhill

02865

Lincoln Research, Lincoln

C1117ABH

Novain Neurociencias Group, Buenos Aires

C1405BOA

Instituto Nacional de Psicopatología (INAPSI), Buenos Aires

C1425AHQ

Fundacion para el estudio y tratamiento de las enfermedades mentales (FETEM), Buenos Aires

602 00

Saint Anne, s.r.o., Psychiatricke oddeleni, Brno - Mesto

397 01

Psychiatricka lecebna U Honzicka, Písek

100 00

Clintrial s.r.o., Prague

106 00

Psychiatricka ambulance, Prague

149 00

Psychiatricka ambulance, Prague

190 00

Psychiatricka ambulance Prosek, Prague

750 01

Telemens, s.r.o., Přerov

002-8029

Goryokai Medical Corporation, Sapporo

Unknown

Asakayama General Hospital, Sakai

861-8002

Yuge Hospital, Kumamoto

114-0024

Nishigahara Hospital, Tokyo

933-0917

Kawada Hospital, Toyama

81-361

NZOZ Syntonia, Gdynia

25-411

NZOZ BioMed, Kielce

95-080

NZOZ Prywatna Klinika Psychiatryczna Inventiva, Tuszyn

All Listed Sponsors
lead

Sumitomo Pharma America, Inc.

INDUSTRY

NCT01575561 - 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 | Biotech Hunter | Biotech Hunter