Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

PHASE3TerminatedINTERVENTIONAL
Enrollment

867

Participants

Timeline

Start Date

April 30, 2010

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2013

Conditions
Depression
Interventions
DRUG

Armodafinil

Armodafinil tablets, taken orally, once daily in the morning

Trial Locations (158)

1032

Teva Investigational Site 661, Budapest

1036

Teva Investigational Site 664, Budapest

1083

Teva Investigational Site 662, Budapest

1377

Teva Investigational Site 147, Sofia

1428

Teva Investigational Site 237, Buenos Aires

1431

Teva Investigational Site 854, Sofia

Teva Investigational Site 855, Sofia

1632

Teva Investigational Site 247, Sofia

2000

Teva Investigational Site 238, Rosario

2195

Teva Investigational Site 710, Johannesburg

3144

Teva Investigational Site 240, Malvern

4000

Teva Investigational Site 249, Plovdiv

4002

Teva Investigational Site 145, Plovdiv

4053

Teva Investigational Site 141, Brisbane

4080

Teva Investigational Site 281, Kiev

4321

Teva Investigational Site 666, Nagykálló

4400

Teva Investigational Site 853, Pazardzhik

5800

Teva Investigational Site 852, Pleven

6100

Teva Investigational Site 148, Kazanlak

7003

Teva Investigational Site 370, Rousse

7530

Teva Investigational Site 712, Cape Town

7646

Teva Investigational Site 711, Paarl

7708

Teva Investigational Site 709, Cape Town

8000

Teva Investigational Site 248, Burgas

9002

Teva Investigational Site 851, Varna

9010

Teva Investigational Site 245, Varna

10023

Teva Investigational Site 202, New York

10090

Teva Investigational Site 633, Zagreb

Teva Investigational Site 634, Zagreb

10305

Teva Investigational Site 411, Staten Island

10312

Teva Investigational Site 110, Staten Island

11000

Teva Investigational Site 175, Belgrade

Teva Investigational Site 177, Belgrade

Teva Investigational Site 831, Belgrade

Teva Investigational Site 833, Belgrade

11201

Teva Investigational Site 207, Brooklyn

11235

Teva Investigational Site 104, Brooklyn

14618

Teva Investigational Site 129, Rochester

18000

Teva Investigational Site 837, Niš

18104

Teva Investigational Site 406, Allentown

19063

Teva Investigational Site 117, Media

21018

Teva Investigational Site 182, Vinnytsia

21208

Teva Investigational Site 300, Pikesville

23230

Teva Investigational Site 404, Richmond

23330

Teva Investigational Site 834, Novi Kneževac

27609

Teva Investigational Site 105, Raleigh

28822

Teva Investigational Site 434, Coslada (Madrid)

28832

Teva Investigational Site 655, Achim

30029

Teva Investigational Site 153, Nîmes

30080

Teva Investigational Site 204, Smyrna

30308

Teva Investigational Site 205, Atlanta

30328

Teva Investigational Site 116, Atlanta

32250

Teva Investigational Site 606, Jacksonville Beach

32256

Teva Investigational Site 132, Jacksonville

32607

Teva Investigational Site 131, Gainesville

33161

Teva Investigational Site 119, North Miami

33319

Teva Investigational Site 127, Lauderhill

33613

Teva Investigational Site 118, Tampa

Teva Investigational Site 608, Tampa

34000

Teva Investigational Site 176, Kragujevac

35216

Teva Investigational Site 113, Birmingham

35226

Teva Investigational Site 225, Birmingham

36006

Teva Investigational Site 183, Poltava

38119

Teva Investigational Site 106, Memphis

39100

Teva Investigational Site 286, Dole

39232

Teva Investigational Site 290, Flowood

41515

Teva Investigational Site 371, La Plata

44125

Teva Investigational Site 190, Beachwood

44718

Teva Investigational Site 213, Canton

45267

Teva Investigational Site 610, Cincinnati

45408

Teva Investigational Site 102, Dayton

47905

Teva Investigational Site 600, Lafayette

49027

Teva Investigational Site 181, Dnipropetrovsk

50134

Teva Investigational Site 689, Florence

51000

Teva Investigational Site 635, Rijeka

56126

Teva Investigational Site 687, Pisa

60068

Teva Investigational Site 195, Park Ridge

60181

Teva Investigational Site 219, Oakbrook Terrace

60563

Teva Investigational Site 107, Naperville

Teva Investigational Site 301, Naperville

61068

Teva Investigational Site 282, Kharkiv

63139

Teva Investigational Site 133, St Louis

65014

Teva Investigational Site 280, Odesa

Teva Investigational Site 875, Odesa

65128

Teva Investigational Site 871, S. Oleksandrivka

73103

Teva Investigational Site 401, Oklahoma City

73112

Teva Investigational Site 609, Oklahoma City

Teva Investigational Site 616, Oklahoma City

75062

Teva Investigational Site 224, Irving

75115

Teva Investigational Site 403, DeSoto

77090

Teva Investigational Site 228, Houston

77546

Teva Investigational Site 612, Friendswood

78756

Teva Investigational Site 111, Austin

79012

Teva Investigational Site 873, Lviv

80952

Teva Investigational Site 257, Gdansk

82007

Teva Investigational Site 699, Bratislava

83099

Teva Investigational Site 872, Donetsk

84058

Teva Investigational Site 409, Orem

84107

Teva Investigational Site 408, Salt Lake City

87109

Teva Investigational Site 193, Albuquerque

90660

Teva Investigational Site 200, Pico Rivera

90703

Teva Investigational Site 217, Cerritos

Teva Investigational Site 223, Cerritos

91045

Teva Investigational Site 180, Luhansk

91101

Teva Investigational Site 698, Trenčín

91403

Teva Investigational Site 295, Sherman Oaks

92056

Teva Investigational Site 303, Oceanside

Teva Investigational Site 400, Oceanside

92123

Teva Investigational Site 128, San Diego

92126

Teva Investigational Site 201, San Diego

92251

Teva Investigational Site 121, Imperial

92591

Teva Investigational Site 122, Temecula

92705

Teva Investigational Site 192, Santa Ana

Teva Investigational Site 292, Santa Ana

92804

Teva Investigational Site 229, Anaheim

92845

Teva Investigational Site 115, Garden Grove

95006

Teva Investigational Site 184, Simferopol

95124

Teva Investigational Site 688, Catania

97901

Teva Investigational Site 697, Rimavská Sobota

98007

Teva Investigational Site 100, Bellevue

98033

Teva Investigational Site 613, Kirkland

99204

Teva Investigational Site 605, Spokane

02472

Teva Investigational Site 603, Watertown

08054

Teva Investigational Site 103, Mount Laurel

Teva Investigational Site 212, Mount Laurel

C1012AAU

Teva Investigational Site 450, Buenos Aires

C1058AAJ

Teva Investigational Site 881, Buenos Aires

C1117ABH

Teva Investigational Site 884, Buenos Aires

C1405BOA

Teva Investigational Site 136, Buenos Aires

C1425AHQ

Teva Investigational Site 134, Buenos Aires

C1425CDC

Teva Investigational Site 235, Buenos Aires

Unknown

Teva Investigational Site 462, Buenos Aires

5004ALB

Teva Investigational Site 135, Córdoba

X5009BIN

Teva Investigational Site 236, Córdoba

01900

Teva Investigational Site 138, La Plata, Buenos Aires

22270-060

Teva Investigational Site 624, Rio de Janeiro

06600

Teva Investigational Site 146, Kardzhali

V1Y 1Z9

Teva Investigational Site 198, Kelowna

L5M 4N4

Teva Investigational Site 296, Mississauga

L5M4N4

Teva Investigational Site 196, Mississauga

V2A 4M4

Teva Investigational Site 299, Penticton

01307

Teva Investigational Site 651, Dresden

00193

Teva Investigational Site 692, Rome

15-879

Teva Investigational Site 259, Bialystok

80-282

Teva Investigational Site 258, Gdansk

25-317

Teva Investigational Site 156, Kielce

31-526

Teva Investigational Site 155, Krakow

64-100

Teva Investigational Site 256, Leszno

60-185

Teva Investigational Site 255, Skorzewo

71-460

Teva Investigational Site 861, Szczecin

95-080

Teva Investigational Site 157, Tuszyn

11 000

Teva Investigational Site 832, Belgrade

04801

Teva Investigational Site 696, Rožňava

0046

Teva Investigational Site 708, Centurion

0181

Teva Investigational Site 706, Pretoria

03804

Teva Investigational Site 336, Alcoy

01004

Teva Investigational Site 433, Vitoria-Gasteiz

01006

Teva Investigational Site 430, Vitoria-Gasteiz

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cephalon

INDUSTRY