Open-label Study to Evaluate the Effectiveness of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

748

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

November 30, 2016

Study Completion Date

December 31, 2016

Conditions
Bipolar I
Interventions
DRUG

Aripiprazole

400mg or 300mg, intramuscular injections every 4 weeks.

Trial Locations (142)

110

Taipei

10003

New York

10023

New York

10305

Staten Island

10312

Staten Island

10326

Goyang-si

11241

Brooklyn

14215

Buffalo

14615

Rochester

14618

Rochester

18104

Allentown

19063

Media

20877

Gaithersburg

21208

Baltimore

23230

Richmond

29201

Columbia

30030

Decatur

30080

Smyrna

30331

Atlanta

30450

Perak

30900

Nîmes

31000

Toulouse

31250

Johor Bahru

32256

Jacksonville

32607

Gainesville

32801

Orlando

33012

Hialeah

33613

Tampa

34748

Leesburg

35226

Birmingham

38119

Memphis

45219

Cincinnati

53562

Middleton

60194

Schaumburg

60522

Hinsdale

60563

Naperville

60611

Chicago

60612

Chicago

63128

St Louis

63368

O'Fallon

66206

Prairie Village

68526

Lincoln

70629

Lake Charles

72211

Little Rock

72758

Rogers

73103

Oklahoma City

73112

Oklahoma City

73118

Oklahoma City

75074

Plano

75093

Plano

75243

Dallas

76012

Arlington

76309

Wichita Falls

77478

Sugar Land

78754

Austin

78990

Élancourt

80910

Colorado Springs

84058

Orem

84106

Salt Lake City

87025

Limoges

90210

Beverly Hills

90230

Culver City

90660

Pico Rivera

90706

Bellflower

91786

Upland

91945

Lemon Grove

92102

San Diego

92506

Riverside

92591

Temecula

92595

Wildomar

92626

Costa Mesa

92845

Garden Grove

92868

Orange

93250

Sarawak

94607

Oakland

97210

Portland

98007

Bellevue

99204

Spokane

130086

Târgovişte

540096

Târgu Mureş

700282

Iași

02131

Boston

08009

Berlin

08002

Cherry Hill

B4N 4K9

Kentville

N7L 1C1

Chatham

H-1135

Budapest

H-4400

Nyireghaza

H-2600

Vác

814-0133

Fukuoka

819-0037

Fukuoka

830-0033

Fukuoka

960-0102

Fukushima

961-0021

Fukushima

963-0207

Fukushima

375-0017

Gunma

377-0055

Gunma

311-3193

Ibaraki

319-1221

Ibaraki

820-0014

Iizuka

216-8511

Kanagawa

221-0801

Kanagawa

223-0062

Kanagawa

225-0003

Kanagawa

238-0042

Kanagawa

259-1304

Kanagawa

783-8505

Kochi

780-0062

Kouchi

861-8002

Kumamoto

380-8582

Nagano-ken

700-0915

Okayama

901-1105

Okinawa

901-2553

Okinawa

567-0017

Osaka

545-8586

Ōsaka

569-1041

Ōsaka

570-0005

Ōsaka

573-1183

Ōsaka

589-0011

Ōsaka

002-8029

Sapporo

420-0839

Shizuoka

151-0053

Tokyo

162-0843

Tokyo

170-0002

Tokyo

175-0091

Tokyo

175-0094

Tokyo

187-8551

Tokyo

992-0601

Yamagata

866-0043

Yatsushiro

85-001

Bydgoszcz

86-200

Chełmno

16-070

Choroszcz

80-438

Gdansk

20-109

Lublin

05-802

Pruszków

95-080

Tuszyn

010825

Bucharest

030455

Bucharest

041915

Bucharest

690-767

Jeju City

136-705

Seoul

139-711

Seoul

All Listed Sponsors
collaborator

H. Lundbeck A/S

INDUSTRY

lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT01710709 - Open-label Study to Evaluate the Effectiveness of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder | Biotech Hunter | Biotech Hunter