Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

1,262

Participants

Timeline

Start Date

October 27, 2011

Primary Completion Date

December 23, 2013

Study Completion Date

December 23, 2013

Conditions
Major Depressive Disorder
Interventions
DRUG

SPD489 (Lisdexamfetamine dimesylate )

Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (oral, 20, 30, 50 or 70 mg, once daily) for 8 weeks

DRUG

Placebo

Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks

Trial Locations (85)

10090

Psychiatric Clinic Vrapoe, Zagreb

10168

Fieve Clinical Research, New York

10312

Richmond Behavioral Associates, Staten Island

10549

Bioscience Research, LLC, Mount Kisco

15107

Paramount Clinical Research, Bridgeville

15213

University of Pittsburgh School of Medicine, Pittsburgh

19063

Suburban Research Associates, Media

19139

CRI Worldwide LLC, Philadelphia

20852

Office of Marc Hertzman, MD, Rockville

20877

Potomac Grove Clinical Research Center, Gaithersburg

21208

Pharmasite Research, Inc., Baltimore

27707

Triangle Neuropsychiatry, Durham

27809

Rcihard H. Weisler, MD, PA & Associates, Raleigh

28031

Hospital Universitario Infanta Leonor, Madrid

28922

Hospital Fundacion de Alcorcon, Madrid

30080

Carman Research, Smyrna

32547

Emerald Coast Mood & Memory, PA, Fort Walton Beach

32751

Florida Clinical Research Center, LLC., Maitland

32806

Compass Research, LLC, Orlando

33011

Centro de Salud Mental Il la Corredoria, Oviedo

33067

CNS Clinical Research Group, Coral Springs

33613

Stedman Clinical Trials, Tampa

33709

Meridien Research, St. Petersburg

34652

Suncoast Clinical Research, New Port Richey

35216

Birmingham Research Group, Birmingham

37000

Hospital Aranda de la Parra, León

37003

Centro Salud Alamedilla Unidad de Salud Mental, Salamanca

37203

Clinical Research Associates, Nashville

38119

Clinical Neuroscience Solutions, Inc., Memphis

41042

MCM Clinical Research LLC, Florence

45040

Lindner Center of HOPE, Mason

45227

Community Research, Cincinnati

46260

The Davis Clinic, Indianapolis

46383

Northwest Indiana Center for Clinical Research, Valparaiso

49021

Complejo hospitalario de Zamora, Zamora

50009

Hospital Clinico Universitario Lozano Blesa, Zaragoza

60523

American Medical Research, Inc., Oak Brook

63301

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

64710

Instituto de Infromacion e Investigación en Salud Mental (INFOSAME), Nuevo León

73112

SP Research, PLLC, Oklahoma City

78200

Consultorio Especializado en Psiquiatria Infantil y Adolescentes, San Luis Potosí City

78731

FutureSearch Clinical Trials, LP, Austin

82126

B & B Investigaciones Medicas S.C., Sinaloa

84015

Ericksen Research and Development, Clinton

90650

South Coast Clinicals, Norwalk

90746

AV Institue, Inc., Carson

91106

Pasadena Research Institute, LLC, Pasadena

92056

North County Clinical Research, Oceanside

92108

Affiliated Research Institute, San Diego

92121

Clinical Innovations, Inc., San Diego

92123

Sharp Mesa Vista Hospital, San Diego

92612

University of California, Irvine Child Development Center, Irvine

97210

Summit Research Network (Oregon) Inc., Portland

98104

Summit Research Network (Seattle) LLC, Seattle

06518

Geriatric and Adult Psychiatry, LLC, Hamden

06457

Middlexex Hospital Center for Behavioral Health, Middletown

02472

Adams Clinical Trials, LLC, Watertown

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

L6T 0G1

Aggarwal & Associates Ltd., Brampton

L7R 4E2

Depression, Mood Disorders and Schizophrenia Treatment Centre, Burlington

N7M 5L9

Chatham-Kent Clinical Trials Research Center, Chatham

N6A 4H1

Regional Mental Health Care, London

L5M 4N4

Anxiety and Mood Disorder Center, Mississauga

Medical Research Associates, Mississauga

L6J0B2

A.K. Karan Holdings, Oakville

P2A 3A4

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

M4W 2N4

START Clinic for Mood and Anxiety Disorders, Toronto

M5T2S8

Univ Health Network, Toronto Western Hospital, Toronto

M6J 3S3

Sleep & Alertness Clinic (Sleep & Alertness Research, Inc.), Toronto

M9W 4L6

Manna Research, Toronto

N9C 3Z4

Windsor Regional Hospital-Tayfour Campus, Windsor

J8A1K7

Pierre-Janet Hospital, Gatineau

H1N 3M5

l'Hopital Louis H. Lafontaine, Montreal

H9R 4S3

Kells Medical Research Group Inc., Pointe-Claire

G3K 2P8

ALPHA Recherche Clinique, Québec

J1H 4J6

Q&T Research Sherbrooke, Sherbrooke

10 000

Poliklinika Neuron, Zagreb

647-10

Centro Regiomontano de Investigacion S.C. (CRI), Monterrey

00907

Dharma Institute & Research Center, San Juan

00918

INSPIRA Clinical Research, San Juan

08025

Hospital de la Santa Creo l Sant Pau, Barcelona

08907

Hospital Universitari de Bellvitge, Servicio de Psiquiatria, Barcelona

Unknown

Hospital Universitario de Henares, Madrid

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY

NCT01436149 - Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder | Biotech Hunter | Biotech Hunter