Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

399

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

July 31, 2013

Study Completion Date

July 31, 2013

Conditions
Depression
Interventions
DRUG

Armodafinil

Armodafinil tablets, taken orally, once daily in the morning

DRUG

Placebo

Matching placebo tablets, taken orally, once daily in the morning

Trial Locations (130)

Unknown

Teva Investigational Site 225, Birmingham

Teva Investigational Site 295, Sherman Oaks

Teva Investigational Site 122, Temecula

Teva Investigational Site 606, Jacksonville Beach

Teva Investigational Site 127, Lauderhill

Teva Investigational Site 608, Tampa

Teva Investigational Site 116, Atlanta

Teva Investigational Site 205, Atlanta

Teva Investigational Site 195, Park Ridge

Teva Investigational Site 611, Indianapolis

Teva Investigational Site 600, Lafayette

Teva Investigational Site 603, Watertown

Teva Investigational Site 207, Brooklyn

Teva Investigational Site 202, New York

Teva Investigational Site 110, Staten Island

Teva Investigational Site 411, Staten Island

Teva Investigational Site 614, Wilmington

Teva Investigational Site 610, Cincinnati

Teva Investigational Site 615, Toledo

Teva Investigational Site 401, Oklahoma City

Teva Investigational Site 609, Oklahoma City

Teva Investigational Site 616, Oklahoma City

Teva Investigational Site 406, Allentown

Teva Investigational Site 403, DeSoto

Teva Investigational Site 612, Friendswood

Teva Investigational Site 408, Salt Lake City

Teva Investigational Site 613, Kirkland

Teva Investigational Site 605, Spokane

Teva Investigational Site 134, Buenos Aires

Teva Investigational Site 136, Buenos Aires

Teva Investigational Site 881, Buenos Aires

Teva Investigational Site 884, Buenos Aires

Teva Investigational Site 888, Buenos Aires

Teva Investigational Site 236, Córdoba

Teva Investigational Site 135, Córdoba Capital

Teva Investigational Site 371, La Plata

Teva Investigational Site 886, La Plata

Teva Investigational Site 138, La Plata, Buenos Aires

Teva Investigational Site 882, Mendoza

Teva Investigational Site 883, Mendoza

Teva Investigational Site 885, Mendoza

Teva Investigational Site 887, Mendoza

Teva Investigational Site 238, Rosario

Teva Investigational Site 623, Belo Horizonte

Teva Investigational Site 626, Curitiba-Parana

Teva Investigational Site 621, Distrito de Rubiao Junior

Teva Investigational Site 627, Itapira -Sao Paulo

Teva Investigational Site 624, Rio de Janeiro

Teva Investigational Site 622, Salvador

Teva Investigational Site 628, São Paulo

Teva Investigational Site 248, Burgas

Teva Investigational Site 146, Kardzhali

Teva Investigational Site 148, Kazanlak

Teva Investigational Site 853, Pazardzhik

Teva Investigational Site 852, Pleven

Teva Investigational Site 145, Plovdiv

Teva Investigational Site 370, Rousse

Teva Investigational Site 147, Sofia

Teva Investigational Site 149, Sofia

Teva Investigational Site 244, Sofia

Teva Investigational Site 247, Sofia

Teva Investigational Site 854, Sofia

Teva Investigational Site 855, Sofia

Teva Investigational Site 245, Varna

Teva Investigational Site 851, Varna

Teva Investigational Site 856, Varna

Teva Investigational Site 635, Rijeka

Teva Investigational Site 631, Split

Teva Investigational Site 632, Zagreb

Teva Investigational Site 633, Zagreb

Teva Investigational Site 634, Zagreb

Teva Investigational Site 716, Helsinki

Teva Investigational Site 717, Helsinki

Teva Investigational Site 719, Kangasala

Teva Investigational Site 718, Turku

Teva Investigational Site 655, Achim

Teva Investigational Site 656, Berlin

Teva Investigational Site 653, Cologne

Teva Investigational Site 651, Dresden

Teva Investigational Site 654, Freiburg im Breisgau

Teva Investigational Site 652, Mittweida

Teva Investigational Site 661, Budapest

Teva Investigational Site 662, Budapest

Teva Investigational Site 664, Budapest

Teva Investigational Site 665, Győr

Teva Investigational Site 666, Nagykálló

Teva Investigational Site 688, Catania

Teva Investigational Site 689, Florence

Teva Investigational Site 686, Genova

Teva Investigational Site 691, Lido Di Camaiore(LU)

Teva Investigational Site 690, Naples

Teva Investigational Site 687, Pisa

Teva Investigational Site 693, Pisa

Teva Investigational Site 692, Roma

Teva Investigational Site 259, Bialystok

Teva Investigational Site 257, Gdansk

Teva Investigational Site 258, Gdynia

Teva Investigational Site 155, Krakow

Teva Investigational Site 255, Skorzewo

Teva Investigational Site 861, Szczecin

Teva Investigational Site 157, Tuszyn

Teva Investigational Site 177, Belgrade

Teva Investigational Site 831, Belgrade

Teva Investigational Site 832, Belgrade

Teva Investigational Site 835, Belgrade

Teva Investigational Site 176, Kragujevac

Teva Investigational Site 837, Niš

Teva Investigational Site 834, Novi Kneževac

Teva Investigational Site 700, Bojnice

Teva Investigational Site 699, Bratislava

Teva Investigational Site 697, Rimavská Sobota

Teva Investigational Site 696, Rožňava

Teva Investigational Site 698, Trenčín

Teva Investigational Site 707, Cape Town

Teva Investigational Site 709, Cape Town

Teva Investigational Site 712, Cape Town

Teva Investigational Site 708, Centurion

Teva Investigational Site 710, Johannesburg

Teva Investigational Site 711, Paarl

Teva Investigational Site 706, Pretoria

Teva Investigational Site 181, Dnipropetrovsk

Teva Investigational Site 872, Donetsk

Teva Investigational Site 282, Kharkiv

Teva Investigational Site 281, Kiev

Teva Investigational Site 180, Luhansk

Teva Investigational Site 873, Lviv

Teva Investigational Site 875, Odesa

Teva Investigational Site 183, Poltava

Teva Investigational Site 871, S. Oleksandrivka

Teva Investigational Site 182, Vinnytsia

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cephalon

INDUSTRY

NCT01305408 - Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder | Biotech Hunter | Biotech Hunter