Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

493

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

October 31, 2011

Study Completion Date

October 31, 2011

Conditions
Bipolar Disorder Mania
Interventions
DRUG

Aripiprazole

5-, 10-, or 15-mg oral tablets in titrated doses for 12 weeks

DRUG

Placebo

Tablets, Oral, 0 mg, once daily, 12 weeks

DRUG

Lithium

Participant's ongoing dose

DRUG

Valproate

Participant's ongoing dose

Trial Locations (73)

1083

Local Institution, Budapest

1090

Local Institution, Vienna

1097

Local Institution, Budapest

1125

Local Institution, Budapest

1135

Local Institution, Budapest

1939

Local Institution, Vereeniging

2001

Local Institution, Soweto

2198

Local Institution, Johannesburg

3600

Local Institution, Pinetown

5020

Local Institution, Salzburg

5700

Local Institution, Gyula

7530

Local Institution, Cape Town

9024

Local Institution, Győr

14233

Local Institution, Nea Ionia-Athens

16070

Local Institution, Choroszcz

16132

Local Institution, Genova

19124

Local Institution, La Spezia

20100

Local Institution, Denizli

20121

Local Institution, Milan

21000

Local Institution, Dijon

22100

Local Institution, Tripoli

28046

Local Institution, Madrid

30120

Local Institution, Murcia

30900

Local Institution, Nîmes

31850

Local Institution, Beaupuy

34295

Local Institution, Montpellier

39100

Local Institution, Dole

41201

Local Institution, Litoměřice

44606

Local Institution, Saint-Nazaire

51092

Local Institution, Reims

53200

Local Institution, Château-Gontier

56126

Local Institution, Pisa

63001

Local Institution, Clermont-Ferrand

67091

Local Institution, Strasbourg

67173

Local Institution, Brumath

71100

Local Institution, Foggia

73479

Local Institution, Ellwangen

73760

Local Institution, Ostfildern

75116

Local Institution, Paris

76300

Local Institution, Sotteville-lès-Rouen

78110

Local Institution, Le Vésinet

80131

Local Institution, Napoli

84037

Local Institution, Sant'Arsenio (Salerno)

85400

Local Institution, Leros

86100

Local Institution, Campobasso

115522

Local Institution, Moscow

119992

Local Institution, Moscow

141371

Local Institution, Khot'kovo

175003

Local Institution, Jonzac

192019

Local Institution, Saint Petersburg

344010

Local Institution, Rostov-on-Don

350087

Local Institution, Krasnodar

400012

Local Institution, Cluj-Nappoca

443016

Local Institution, Samara

634014

Local Institution, Tomsk

700282

Local Institution, Iași

500 05

Local Institution, Hradec Králové

101 00

Local Institution, Prague

120 00

Local Institution, Prague

160 00

Local Institution, Prague

151 26

Local Institution, Athens

06034

Local Institution, Foligno (Pg)

00168

Local Institution, Roma

00189

Local Institution, Roma

80-952

Local Institution, Gdansk

30-393

Local Institution, Krakow

31-501

Local Institution, Krakow

60-572

Local Institution, Poznan

86-100

Local Institution, Swiecie N/Wisla

041915

Local Institution, Bucharest

08036

Local Institution, Barcelona

06100

Local Institution, Ankara

07070

Local Institution, Antalya

Sponsors
All Listed Sponsors
collaborator

Otsuka America Pharmaceutical

INDUSTRY

lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY