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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,105

Participants

Timeline

Start Date

October 19, 2011

Primary Completion Date

December 10, 2013

Study Completion Date

December 10, 2013

Conditions
Major Depressive Disorder
Interventions
DRUG

Antidepressant + 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

Antidepressant + 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 (101)

1083

Semmelweis Univ. Dept.of Psychiatry, Budapest

2195

Private Practice - Gerta Brink, Johannesburg

4320

Santha Kalman Mentalis Egeszsegkozpont es Szakkorhaz, Nagykálló

6529

George Medi Clinic Extension, George

7530

Cape Trial Centre, Bellville

Flexivest Fourteen Research Centre, Bellville

9100

Dr Lieven De Weirdt, Sint-Niklaas

10000

Clintrial s.r.o., Prague

10023

Medical & Behavioral Health Research, PC, New York

10245

Private Praxis Dr. Jana Thomsen, Berlin

10614

North Estonia Medical Centre Foundation Psychiatry Clinic, Tallinn

10617

Marienthal Psychiatry and Psychology Center, Tallinn

10629

emovis GmbH, Berlin

11214

Brooklyn Medical Institute, Brooklyn

11486

Medinstructor Lippitz AB, Stockholm

13156

Alexander Schulze, MD, Berlin

15800

Psychiatry Trial s.r.o., Prague

18104

Lehigh Center for Clinical Research, Allentown

19053

Somni bene GmbH, Schwerin

19131

Belmont Center for Comprehensive Treatment, Philadelphia

20100

Puutorin Psykiatripalvelu, Turku

21153

Ekdahl Medical AB, Malmo

INM Psykiatrisk Mottagning, Malmo

22222

ProbarE i Lund AB, Lund

26200

Satakunnan Psykiatripalveiu Oy at Mentoria Oy, Tampere

26655

Studiezentrum Nord-West, Westerstede

28832

Gemeinschafstpraxis für Neurologie und Psychiatrie, Psychotherapie, Achim

29406

Medical University South Carolina Anxiety Disorder Program, North Charleston

30308

Atlanta Center for Medical Research, Atlanta

30328

Atlanta Institute of Medicine & Research, Atlanta

32806

Clinical Neuroscience Solutions, Inc., Orlando

33161

Scientific Clinical Research, Inc., North Miami

33407

Janus Center for Psychiatric Research, West Palm Beach

33716

Comprehensive NeuroScience, Inc., St. Petersburg

34201

Florida Clinical Research Center, LLC, Bradenton

37067

Psychiatric Consultants, PC, Franklin

38119

Research Strategies of Memphis, LLC, Memphis

41201

Bialbi s.r.o., Litoměřice

41685

SU/ Affektiva 1, Gothenburg

44130

North Star Medical Research, LLC, Middleburg Heights

44805

Private Practice Drs. Bitter/Schumann, Bochum

45417

Midwest Clinical Research Center, Dayton

47630

Pedia Research, Newburgh

48149

Universitaetsklinikum Munster, Münster

50406

Jaanson & Laane OU, Tartu

50417

Tartu University Hospital Psychiatric Clinic, Tartu

57072

Private Practice: Eugen Schlegel, Siegen

60200

Saint Anne s.r.o., Brno

63141

Mercy Health Research, St Louis

64114

The Center for Pharmaceutical Research, Kansas City

64118

Comprehensive Psychiatric Associates, Gladstone

67207

Heartland Research Associates, Wichita

70100

Satucon Oy, Kuopio

71115

Louisiana Clinical Research, LLC, Shreveport

72201

K&S Professional Research Services, LLC, Little Rock

73112

Sooner Clinical Research, Oklahoma City

75230

KRK Medical Research, Dallas

75231

Future Search Trials of Dallas, LP, Dallas

75310

Dr. Wahlstedts mottagning, Uppsala

78229

Clinical Trials of Texas, Inc., San Antonio

80012

Parnu Hospital, Psychiatric Clinic, Pärnu

80333

Studienzentrum Muenchen, München

80910

MCB Clinical Research Centers, Colorado Springs

85251

ResearchOne, Inc., Scottsdale

90241

Diligent Clinical Trials, Downey

90419

Studienzentrum Klinikum Nuernberg, Nuremberg

92025

Synergy Clinical Reserach Center of Escondido, Escondido

92374

Anderson Clinical Research, Redlands

92408

BreakThrough Clinical Trials, LLC, San Bernardino

92626

ATP Clinical Research, Inc., Costa Mesa

94612

Pacific Research Partners, LLC, Oakland

97070

Medizinisches Studienzentrum Wuerzburg, Würzburg

130081

Lorentina 2201 SRL, Târgovişte

310022

Spitatul Clinic Judetean de Urgenta Arad, Clinica de Psihiatrie, Arad

410163

Crucea Alba, Oradea

540095

Spitalul Clinic Judetean Mures, Târgu Mureş

710107

Stefi-Dent SRL, Botoșani

08755

Bio Behavioral Health, Toms River

615 00

Psychiatricka ambulance, Brno

268 01

Medicana s.r.o., Hořovice

284 01

Psychiatrie s.r.o., Kutná Hora

160 00

Prague Medical Services s.r.o., Prague

251 01

Ricany s.r.o., Říčany

00100

ARTES Psykiatrinen Palvelukeskus Oy, Helsinki

01307

University Hospital Carl Gustav Carus, Dresden

04157

ZSL Zentrum fuer medizinische Studien in Leipzig, Leipzig

H-4032

Debrecent Egyetem Orvos es Egeszsegtudomanyl Centrum Pszichiatrai, Debrecen

H-4400

Josa Andras Teaching Hospital, Nyíregyháza

Unknown

Pecsi Tudomanyegyeiem Pszichiatriai es Pszichoterapias Klinika, Sziget

Somerset West Clinical Research, Somerset West

15-879

"Prywatne Gabinety Lekarskie Promedicus", Bialystok

85-156

NZOZ Centrum Kultury, Higieny i Zdrowia Psychicznego, Bydgoszcz

86-200

Zespol Opieki Zdrowotnej w Chelmnie, Chełmno

80-546

Centrum Badan Klinicznuch Pl-House sp. z.o.o., Gdansk

80-952

Klinika Chorob Psychicznych i Zaburzen Nerwicowych, Gdansk

38-300

Centrum Psychiatrii i Psychoterapli, Gorlice

25-317

NZOZ Syntonia, Poradnia Zdrowia Psychicznego, Kielce

20-022

Osrodek Badafi Klinicznych Prof dr hab n med Meszek Szczepanski Prywatna Praktyka Lekarska, Lublin

09-300

Samodzielny Publiczny Zespol Zakladow Opieki Zdrowotnej w Zurominie, Żuromin

041915

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

0046

Vista Clinic, Centurion

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY