SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study

PHASE3TerminatedINTERVENTIONAL
Enrollment

1,570

Participants

Timeline

Start Date

February 27, 2012

Primary Completion Date

March 27, 2014

Study Completion Date

March 27, 2014

Conditions
Major Depressive Disorder
Interventions
DRUG

SPD489 (Lisdexamfetamine dimesylate) + Antidepressant

SPD489 20mg, 30mg, 50mg, or 70mg + Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily for 52 weeks

Trial Locations (212)

7530

Cape Trial Centre, Bellville

10019

Clinilabs, Inc., New York

10023

Medical & Behavioral Health Research, PC, New York

10075

Fieve Clinical Research, New York

10245

Facharzt fur Neurologie und Psychiatrie, Berlin

10312

Richmond Behavioral Associates, Staten Island

10467

Montefiore Medical Center, The Bronx

10549

Bioscience Research LLC, Mount Kisco

10617

Marienthal Psychiatry & Psychology Center of Mustamae, Tallinn

10629

Emovis GmbH, Berlin

11029

Mount Sinai School of Medicine, New York

11214

Brooklyn Medical Institutes, Brooklyn

11366

Comprehensive Clinical Development, Inc., Fresh Meadows

13156

Complete Facharzt fur Neurologie und Psychiatrie, Berlin

14224

Sleep Medicine Centers of Western New York, West Seneca

15017

Paramount Clinical Research, Bridgeville

15213

UPMC Western Psychiatric Institute and Clinic, Pittsburgh

15800

Psychiatry Trial, s.r.o, Prague

18104

Lehigh Center for Clinical Research, Allentown

19053

Somni bene GmbH, Schwerin

19063

Suburban Research Associates, Media

19107

Thomas Jefferson University, Philadelphia

19131

Belmont Center for Comprehensive Treatment, Philadelphia

19139

CRI Worldwide LLC, Philadelphia

19380

University Services, West Chester

20100

Puutonin Psykiatripalvelu, Turku

20852

Office of Marc Hertzman, MD, Rockville

20877

Potomac Grove Clinical Research Center, Gaithersburg

21208

Pharmasite Research, Inc., Baltimore

23236

Alliance Research Group, Richmond

26655

Gemeinschaftspraxis fur Neurologie und Psychiatrie, Westerstede

27609

Dr. Richard Weisler, Raleigh

27707

Triangle Neuropsyhiatry, Durham

28031

Hospital Universitario Infanta Leonor, Madrid

28601

Clinical Trials of America, Hickory

28922

Hospital Fundacion de Alcorcon, Madrid

29406

Medical University of South Carolina, Anxiety Disorders Program, North Charleston

30080

Carman Research, Smyrna

Institute for Behavioral Medicine, LLC, Smyrna

30308

Atlanta Center for Medical Research, Atlanta

30328

Atlanta Institute of Medicine & Research, Atlanta

32025

Psychiatric Associates, Lake City

32216

Clinical Neuroscience Solutions, Inc., Jacksonville

32256

Amit Vijapura MD, Jacksonville

32547

Emerald Coast Mood & Memory, PA, Fort Walton Beach

32607

Sarkis Clinical Trials, Gainesville

32751

Florida Clinical Research Center, LLC, Maitland

32789

Kolin Research Group, Winter Park

32806

Clinical Neuroscience Solutions, Inc., Orlando

Compass Research, LLC, Orlando

32889

Ali A. Kashfi, MD, PA, Orlando

33011

Centro de Salud Mental II la Corredoria, Oviedo

33067

CNS Clinical Research Group, Coral Springs

33161

Fidelity Clinical Research Inc, North Miami

Scientific Clinical Research Inc., North Miami

33407

Janus Center for Psychiatric Research, West Palm Beach

33613

Stedman Clinical Trials, Tampa

33709

Meridien Research, St. Petersburg

33716

Comprehensive Clinical Development, Inc., St. Petersburg

33880

Clinical Research of Central Florida, Winter Haven

33912

Gulfcoast Clinical Research Center, Fort Myers

34201

Florida Clinical Research Center, LLC, Bradenton

34652

Suncoast Clinical Research, New Port Richey

35216

Birmingham Research Group, Birmingham

37003

Centro de Salud Alamedilla Unidad de Salud Mental, Salamanca

37067

Psychiatric Consultants, PC, Franklin

37203

Clinical Research Associates, Inc., Nashville

38119

Clinical Neuroscience Solutions, Inc., Memphis

Research Strategies of Memphis, LLC, Memphis

41042

MCM Clinical Research LLC, Florence

41201

Bialbi s.r.o., Litoměřice

42301

Pedia Research, LLC, Owensboro

43210

Ohio State University Department of Psychiatry, Columbus

43623

Neurology & Neuroscience Center of Ohio, Toledo

44122

Northcoast Clinical Trials, Beachwood

44130

North Star Medical Research, LLC, Middleburg Heights

44805

Private Practice Drs. Bitter/Schumann, Bochum

45040

Lindner Center for Hope, Mason

45227

Community Research, Inc., Cincinnati

45417

Midwest Clinical Research Center, Dayton

46250

Davis Clinic, Indianapolis

46383

Northwest Indiana Center for Clinical Research, Valparaiso

47630

Pedia Research, LLC, Newburgh

49021

Complejo hospitalario de Zamora, Zamora

50009

Hospital Clinico Universitario Lozano Blesa, Zaragoza

50406

Jaanson & Laane Ou, Tartu

50417

Tartu University Hospital, Tartu

53188

Independent Physician Consultants (dba IPC Research), Waukesha

53562

Dean Foundation for Health, Research, and Education, Middleton

60061

Sleep and Behavior Medicine Institute, Vernon Hills

60076

Psyichiatric Medicine Associates, LLC, Skokie

60169

Alexian Brothers Center for Psychiatric Research, Hoffman Estates

60523

American Medical Research, Inc., Oakbrook Terrace

60612

Rush University Medical Center, Chicago

63109

Mid-America Clinical Research, St Louis

63141

Mercy Health Research, St Louis

63301

St. Charles Psychiatric Associates - Midwest Research Group, Saint Charles

63368

Private Practice - Howard J. Ilivicky, O'Fallon

64114

The Center for Pharmaceutical Research PC, Kansas City

64118

Comprehensive Psyichatric Associates, Gladstone

64710

CRI Centro Regiomontano de Investigacion Clinica S.C, Nuevo León

66206

Clinical Trials Technology, Inc., Prairie Village

67207

Heartland Research Associates, Wichita

68526

Premier Psychiatric Research Institute, Lincoln

70100

Satucon Oy / Privater, Kuopio

71101

Louisiana Clinical Research LLC, Shreveport

72223

Arkansas Psychiatric Clinical Research Trials, P.A., Little Rock

73103

IPS Research Company, Oklahoma City

73112

Sooner Clinical Research, Oklahoma City

SP Research, PPC dba Oklahoma Clinical Research Center, Oklahoma City

75230

KRK Medical Research, Dallas

75231

Future Search Trials of Dallas, LP, Dallas

75243

Pillar Clinical Research, LLC, Dallas

76309

Grayline Clinical Drug Trials, Wichita Falls

77098

Houston Clinical Trials, LLC, Houston

77488

Wharton Research Center, Inc., Wharton

77546

Bay Area Clinical Services, Friendswood

78229

Clinical Trials of Texas, Inc., San Antonio

78731

FutureSearch Clinical Trials, LP, Austin

80209

Western Affiliated Research Institute, Denver

80333

Complete Karlstr, München

80910

MCB Clinical Research Centers, Colorado Springs

82126

B&B Investigaciones Medicas, SC, Sinaloa

84015

Ericksen Research and Development, Clinton

85251

ResearchOne, Inc., Scottsdale

87109

Albuquerque Neuroscience Inc., Albuquerque

89119

Clinical Research Consortium, Las Vegas

90024

Semel Institute for Neuroscience & Human Behavior at UCLA, Los Angeles

90241

Diligent Clinical Trials, Downey

90419

Studienzentrum Klinikum Nuernberg, Nuremberg

90631

Omega Clinical Trials, LLC, La Habra

90746

American Neuropsychiatric Research, Inc., Carson

91106

Pasadena Research Institute, LLC, Pasadena

91403

Caliifornia Neuroscience Research Medical Group, Sherman Oaks

91710

Catalina Research Institute, LLC, Chino

92025

Synergy Clinical Research Center of Escondido, Escondido

92066

North County Clinical Research, Oceanside

92108

Affiliated Research Institute, San Diego

PCSD - Feighner Research, San Diego

92121

Clinical Innovations, Inc., San Diego

92123

Artemis Institute for Clinical Research, San Diego

92324

Shanti Clinical Trials, Colton

92374

Anderson Clinical Research, Redlands

92408

BreakThrough Clinical Trials, LLC, San Bernardino

92612

UC, Irvine Child Development Center, Irvine

92618

Irvine Center For Clinical Research, Irvine

92626

ATP Clinical Research, Costa Mesa

Clinical Innovation, Inc., Costa Mesa

92701

Neuropsychiatric Center of Orange County, Santa Ana

92804

South Coast Clinical Trials, Inc., Anaheim

92845

Collaborative Neuroscience Network, Inc., Garden Grove

94612

Pacific Research Partners, Oakland

97070

Medizinisches Studienzentrum Wuerzburg, Würzburg

97210

Summit Research Network (Oregon) Inc., Portland

98125

Summit Research Network (Seattle) LLC, Seattle

130081

Lorentina 2102 SRL, Târgovişte

540096

Spitalui Clinic Judetean Mures, Târgu Mureş

1270244

Psicomed Estudio Medicos, Antofagasta

7500710

Biomedica Research Group, Providencia

7510186

Centro de Estudios Clinicos (CEC), Providencia

7560356

Especialidades Medicas L y S, Las Condes

92123'

Sharp Mesa Vista Hospital, San Diego

06416

Connecticut Clinical Research, Cromwell

06518

Geriatric and Adult Psychiatry, LLC, Hamden

06106

Institute of Living - Hartford Hospital, Hartford

06050

The Hospital of Central Connecticut, New Britain

02472

Adams Clinical Trials, LLC, Watertown

08002

Center For Emotional Fitness, Cherry Hill

08755

Bio Behavioral Health, Toms River

08046

CRI Worldwide, LLC, Willingboro

02914

Rhode Island Mood & Memory Research Institute, East Providence

V2A 4M4

Dr. Alexander McIntyre Inc, Penticton

V6Z 2L4

Dr. D. McIntosh & Dr. K. Kjernisted Clinical Research Inc., Vancouver

N7M 5L9

Chatham-Kent Clinical Trials Research Centre, Chatham

L5M 4N4

Anxiety and Mood Disorder Center, Mississauga

Dr. Sunny Johnson Medical Corporation, Medican Research Associates, Mississauga

L6J 0B2

A. K. Karan Holdings, Ltd., Oakville

P2A 3A4

International Sleep Clinic, West Parry Sound Health Centre, Parry Sound

M4W2N4

START Clinic for Mood and Anxiety Disorders, Toronto

M6J 3S3

Sleep & Alertness Clinic, Toronto

M9W 4L6

Manna Research, Toronto

J9A 1K7

Recherches Neuro-Hippocampe, Gatineau

H1N 3M5

l'Hopital Louis H. Lafontaine, Montreal

H9R 4S3

Kells Medical Research Group Inc., Pointe-Claire

J1H 4J6

Q & T Research Sherbrooke Inc., Sherbrooke

251 01

Psychiatrie Ricany, Říčany

602 00

Saint Anne s.r.o., Psychiatricka ambulance, Brno

615 00

Psychiatricka ambulance, Brno

268 01

Medicana s.r.o., Hořovice

284 01

Supervize s.r.o., Kutná Hora

120 00

Clintrial s.r.o., Prague

160 00

Medical Services Prague s.r.o., Prague

Unknown

North Estonia Medical Centre Foundation, Tallinn

Semmelweis Egyetem Pszichiatrial es Pszichoterapias Klinkia, Budapest

Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum, Debrecen

Klinika Chorob Psychicznych i Zaburzen Nerwicowych, Gdansk

Somerset West Clinical Research Unit, Somerset West

Flexivest Fourteen Research Centre, Cape Town

00100

ARTES Psykiatrinen Palvelukeskus Oy, Helsinki

04157

ZSL Zentrum fuer medizinische Studien in Leipzig, Leipzig

15-879

"Prywatne Gabinety Lekarskie Promedicus Anna Agnieszka Tomczak", Bialystok

86-200

Zespol Opleki Zdrowotnej w Chelmole, Chełmno

80-546

Centrum Badan Klinicznych PI-House sp. z o. o., Gdansk

Centrum Badan Klinicznych Pl-House, Gdansk

80-952

Klinika Chorob Psychicznych i Zaburzen Nerwicowych Uniwersyteckie Centrum Kliniczne, Gdansk

38-300

Centrum Psychiatrii i Psychoterapi, Gorlice

25-317

NZOZ Syntonia, Kielce

09-300

Samodzieiny Publiczny Zespol Zakladow Opieki Zdrowotnej w Zurominie, Żuromin

00907

Dharma Institute and Research Center, San Juan

00918

INSPIRA Clinical Research, San Juan

041915'

"Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia Sectia Clinica Psihiatrie I", Bucharest

08907

Hospital Universitari de Bellvitge, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY