Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex

PHASE3CompletedINTERVENTIONAL
Enrollment

965

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions
Bipolar I Disorder
Interventions
DRUG

Lurasidone

Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter

DRUG

Placebo

20-80 mg flexible dose

Trial Locations (105)

1036

Obudai Egeszsegugyi Centurm Kft., Budapest

1096

Fovarosi Onkormanyzat Szent Istvan Korhaz es Szent Laszlo Korhaz, Budapest

1125

Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika, Budapest

1135

Nyiro Gyula Korhaz, Budapest

1431

"Multiprofiled Hospital for Active Treatment Alexandrovska", Sofia

1606

Psychiatric Clinic, Military Medical Academy, Sofia

1900

Clinica Privada de Salud Mental Santa Teresa de Avila, La Plata

2000

Centro de Atencion E Invest. Clinica (CAICI), Rosario

3121

The Melbourne Clinic, Richmond

3144

RWF Medic Pty Ltd as Trustee for Farnbach Family Trust at Neurotherapy Victoria, Malvern

4002

"University Multiprofiled Hospital for Active Treatment Sveti Georgi", Plovdiv

5009

Sanatorio Morra, Córdoba

Instituto DAMCI, Córdoba

5112

The Lyell McEwin Hospital, Elizabeth Vale

5500

Centro de Psiquiatria Biologica, Mendoza

5700

Bekes Megyei Kepviselotestulet Pandy Kalman Korhaz, Gyula

6160

Hollywood Medical Centre, Fremantle

7003

Regional Psychiatric Dispensary, Rousse

9010

"Multprofiled Hospital for Active Treatment Sveta Marina", Varna

9024

Petz Aladar Megyei Oktato Korhaz, Győr

10000

Clinical Hospital Centre Zagreb, Zagreb

Klinicki Bolnicki Centar Zagreb-Rebro, Zagreb

University Hospital Centre Zagreb, Zagreg

10003

Village Clinical Research Inc,, New York

10600

Psychiatricka Ambulance, Prague

11000

Clinical Centre of Serbia, Belgrade

Clinical Hospital Centre Dragisa Misovic, Belgrade

14618

Finger Lakes Clinical Research, Rochester

18000

Clinical Centre Nis, Niš

19063

Suburban Research Associates, Media

21033

CHS La Chartreuse-Pole 6, Dijon

23330

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

25411

NZOZ BioMed, Kielce

27014

CETEP, Santiago

Clinica Las Condes, Santiago

Psicomedica, Santiago

29407

Carolina Clinical Trials, Inc., Charleston

30029

CHRU de Nimes, Service de Psychiatrie adulte, Nîmes

30308

Atlanta Center for Medical Research, Atlanta

32216

Clinical Neuroscience Solutions, Inc., Jacksonville

32806

Clinical Neuroscience Solutions, Orlando

33166

Galiz Research, Miami Springs

34000

Psychiatric Clinic Clinical Center Kragujevac, Kragujevac

34201

Florida Clinical Research LLC, Bradenton

34295

Hopital Lapeyronie, Montpellier

36303

Harmonex Neuroscience Research, Dothan

38119

Clinical Neuroscience Solutions Inc., Memphis

39100

Centre Hospitalier Specialise du Jura-Centre Medico Psychiatrique, Dole

44125

Charak Center for Health and Wellness, Garfield Heights

47802

Clinco, Terre Haute

51000

Clinic Hospital Centre Rijeka Clinic for Psychiatry, Rijeka

62500

Fakultni Nemocnice Brno, Brno-Bohunice

Psychiatricke Centrum Praha, Prague 8-Bohunice

63128

Psych Care Consultants Research, St Louis

73116

Cutting Edge Research Groupd, Oklahoma City

75001

Psychosocialni Centrum, Přerov

75235

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

77566

R/D Clinical Research, Inc., Lake Jackson

80000

Psychiatry Dispensary, Burgas

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

94117

SF-CARE, Inc., San Francisco

94304

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

94305

"Stanford University School of Medicine", Stanford

95301

Psychiatricka ambulancia, Zlaté Moravce

97912

Vseobecna Nemocnica Rimavska Sobota, NaP, n.o. Bratislava, Rimavská Sobota

190005

St. Petersburg State Healthcare Institution (SPSHI), Saint Petersburg

St.Petersburg State Healthcare Institution (SPSHI), Saint Petersburg

190121

St Petersburg State Government Healthcare Institution, Saint Petersburg

462054

State Healthcare and Forensic Psychiatric Expertise Institution, Izhevsk

603155

Nizhny Novgorod Regional State Institution of Healthcare, Nizhny Novgorod

634050

Mental Health Research Institute of Rams, Tomsk

08130

ActivMed Practices & Research Inc., Haverhill

02865

Lincoln Research, Lincoln

C1117ABH

Novain Neurociencias Group, Buenos Aires

C1425AHQ

Centro de Neuropsiquiatria, Buenos Aires

Unknown

IPEM-Instituto de Prevención de las Enfermedades Mentales., Buenos Aires

University Hospital Sestremilosrdnice, Zagreb

Haruna Hospital, Shibukawa

Sapporokousetsu Hospital, Sapporo

Nagano Prefectural Mental Wellness Center-Komagane, Komagane

Asakayama General Hospital, Sakai

Ongata Hospital, Hachioji, Tokyo

602 00

Saint Anne s.r.o., Brno

736 01

Psychiatricka ambulance, Havířov

397 01

Psychiatricka Iecebna U Honzicka, Písek

100 00

Clintrial s.r.o., Prague

140 00

Psychiaricka ambulance, Prague

190 00

Psychiatricka ambulance Prosek, Prague

401 13

Psychiatricka ambulance, Ústí nad Labem

H-1135

Fovarosi Onkormanyzat Nyiro Gyula Korhaz, I. Pszichiatria, Budapest

002-8029

Goryokai Medical Corporation, Sapporo

390-0847

Shonan Hospital, Matsumoto-shi

842-0192

National Hospital Organization Hizen Psychiatric Center, Kanzaki

114-0024

Nishigahara Hospital, Kita-ku

470-1168

Okehazama Hospital Fujita Kokoro Care Center, Aichi

861-8002

Yuge Hospital, Kumamoto

904-0012

Arakaki Hospital, Okinawa

933-0917

Kawada Hospital, Toyama

81-361

NZOZ Syntonia, Gdynia

87-100

Wojewodzki Osrodek Lexznictwa Psychiatrycznego w Toruniu, Torun

95-080

Prywatny Gabinet Lekarski Jaroslaw Strzelec, Tuszyn

50-227

"Przychodnia Lekarsko-Psychologiczna Persona Spolka Partnerska Lekarzy", Wroclaw

All Listed Sponsors
lead

Sumitomo Pharma America, Inc.

INDUSTRY

NCT01358357 - Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex | Biotech Hunter | Biotech Hunter