AzTrials
AzTrials

Major Depressive DisorderPhase 3NCT01436175

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

A Phase 3 study testing SPD489 (Lisdexamfetamine dimesylate) + Antidepressant in people with Major Depressive Disorder, run by Shire at 212 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is an optional continuation of previous short-term adult major depressive disorder (MDD) augmentation studies. Patients may only take part in this long-term, open-label research study if they completed a previous double-blind MDD augmentation study using SPD489. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
SPD489 (Lisdexamfetamine dimesylate) + Antidepressant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,570 participants
Where
212 sitesin 14 countries
Study dates
27 Feb 2012to 27 Mar 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has completed 1 of the respective short-term antecedent SPD489 MDD studies and did not experience any clinically significant AEs in the antecedent study that would preclude exposure to SPD489.

Who cannot join

  • Subject has any current co-morbid Axis I or Axis II psychiatric disorder (including a lifetime history of psychosis) which was not present or recognized at entry into the antecedent study or has a concurrent chronic or acute illness or unstable medical condition that may deteriorate that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol

Trial locations and contacts

212 sites in 14 countries.

212 sites in 14 countries

United States140 sites

  • Albuquerque Neuroscience Inc.

    Albuquerque, New Mexico, 87109

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104

  • South Coast Clinical Trials, Inc.

    Anaheim, California, 92804

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30308

  • Atlanta Institute of Medicine & Research

    Atlanta, Georgia, 30328

  • FutureSearch Clinical Trials, LP

    Austin, Texas, 78731

  • Pharmasite Research, Inc.

    Baltimore, Maryland, 21208

  • Northcoast Clinical Trials

    Beachwood, Ohio, 44122

  • Birmingham Research Group

    Birmingham, Alabama, 35216

  • Florida Clinical Research Center, LLC

    Bradenton, Florida, 34201

  • Paramount Clinical Research

    Bridgeville, Pennsylvania, 15017

  • Brooklyn Medical Institutes

    Brooklyn, New York, 11214

  • American Neuropsychiatric Research, Inc.

    Carson, California, 90746

  • Center For Emotional Fitness

    Cherry Hill, New Jersey, 08002

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Catalina Research Institute, LLC

    Chino, California, 91710

  • Community Research, Inc.

    Cincinnati, Ohio, 45227

  • Ericksen Research and Development

    Clinton, Utah, 84015

  • MCB Clinical Research Centers

    Colorado Springs, Colorado, 80910

  • Shanti Clinical Trials

    Colton, California, 92324

  • Ohio State University Department of Psychiatry

    Columbus, Ohio, 43210

  • CNS Clinical Research Group

    Coral Springs, Florida, 33067

  • ATP Clinical Research

    Costa Mesa, California, 92626

  • Clinical Innovation, Inc.

    Costa Mesa, California, 92626

  • Connecticut Clinical Research

    Cromwell, Connecticut, 06416

  • KRK Medical Research

    Dallas, Texas, 75230

  • Future Search Trials of Dallas, LP

    Dallas, Texas, 75231

  • Pillar Clinical Research, LLC

    Dallas, Texas, 75243

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • Western Affiliated Research Institute

    Denver, Colorado, 80209

  • Diligent Clinical Trials

    Downey, California, 90241

  • Triangle Neuropsyhiatry

    Durham, North Carolina, 27707

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02914

  • Synergy Clinical Research Center of Escondido

    Escondido, California, 92025

  • MCM Clinical Research LLC

    Florence, Kentucky, 41042

  • Gulfcoast Clinical Research Center

    Fort Myers, Florida, 33912

  • Emerald Coast Mood & Memory, PA

    Fort Walton Beach, Florida, 32547

  • Psychiatric Consultants, PC

    Franklin, Tennessee, 37067

  • Comprehensive Clinical Development, Inc.

    Fresh Meadows, New York, 11366

  • Bay Area Clinical Services

    Friendswood, Texas, 77546

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

  • Potomac Grove Clinical Research Center

    Gaithersburg, Maryland, 20877

  • Collaborative Neuroscience Network, Inc.

    Garden Grove, California, 92845

  • Comprehensive Psyichatric Associates

    Gladstone, Missouri, 64118

  • Geriatric and Adult Psychiatry, LLC

    Hamden, Connecticut, 06518

  • Institute of Living - Hartford Hospital

    Hartford, Connecticut, 06106

  • Clinical Trials of America

    Hickory, North Carolina, 28601

  • Alexian Brothers Center for Psychiatric Research

    Hoffman Estates, Illinois, 60169

  • Houston Clinical Trials, LLC

    Houston, Texas, 77098

  • Davis Clinic

    Indianapolis, Indiana, 46250

  • UC, Irvine Child Development Center

    Irvine, California, 92612

  • Irvine Center For Clinical Research

    Irvine, California, 92618

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32216

  • Amit Vijapura MD

    Jacksonville, Florida, 32256

  • The Center for Pharmaceutical Research PC

    Kansas City, Missouri, 64114

  • Omega Clinical Trials, LLC

    La Habra, California, 90631

  • Psychiatric Associates

    Lake City, Florida, 32025

  • Clinical Research Consortium

    Las Vegas, Nevada, 89119

  • Premier Psychiatric Research Institute

    Lincoln, Nebraska, 68526

  • Arkansas Psychiatric Clinical Research Trials, P.A.

    Little Rock, Arkansas, 72223

  • Semel Institute for Neuroscience & Human Behavior at UCLA

    Los Angeles, California, 90024

  • Florida Clinical Research Center, LLC

    Maitland, Florida, 32751

  • Lindner Center for Hope

    Mason, Ohio, 45040

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119

  • Research Strategies of Memphis, LLC

    Memphis, Tennessee, 38119

  • North Star Medical Research, LLC

    Middleburg Heights, Ohio, 44130

  • Dean Foundation for Health, Research, and Education

    Middleton, Wisconsin, 53562

  • Bioscience Research LLC

    Mount Kisco, New York, 10549

  • Clinical Research Associates, Inc.

    Nashville, Tennessee, 37203

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Suncoast Clinical Research

    New Port Richey, Florida, 34652

  • Clinilabs, Inc.

    New York, New York, 10019

  • Medical & Behavioral Health Research, PC

    New York, New York, 10023

  • Fieve Clinical Research

    New York, New York, 10075

  • Mount Sinai School of Medicine

    New York, New York, 11029

  • Pedia Research, LLC

    Newburgh, Indiana, 47630

  • Medical University of South Carolina, Anxiety Disorders Program

    North Charleston, South Carolina, 29406

  • Fidelity Clinical Research Inc

    North Miami, Florida, 33161

  • Scientific Clinical Research Inc.

    North Miami, Florida, 33161

  • Private Practice - Howard J. Ilivicky

    O'Fallon, Missouri, 63368

  • American Medical Research, Inc.

    Oakbrook Terrace, Illinois, 60523

  • Pacific Research Partners

    Oakland, California, 94612

  • North County Clinical Research

    Oceanside, California, 92066

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, 73112

  • SP Research, PPC dba Oklahoma Clinical Research Center

    Oklahoma City, Oklahoma, 73112

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32806

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Ali A. Kashfi, MD, PA

    Orlando, Florida, 32889

  • Pedia Research, LLC

    Owensboro, Kentucky, 42301

  • Pasadena Research Institute, LLC

    Pasadena, California, 91106

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Belmont Center for Comprehensive Treatment

    Philadelphia, Pennsylvania, 19131

  • CRI Worldwide LLC

    Philadelphia, Pennsylvania, 19139

  • UPMC Western Psychiatric Institute and Clinic

    Pittsburgh, Pennsylvania, 15213

  • Summit Research Network (Oregon) Inc.

    Portland, Oregon, 97210

  • Clinical Trials Technology, Inc.

    Prairie Village, Kansas, 66206

  • Dr. Richard Weisler

    Raleigh, North Carolina, 27609

  • Anderson Clinical Research

    Redlands, California, 92374

  • Alliance Research Group

    Richmond, Virginia, 23236

  • Office of Marc Hertzman, MD

    Rockville, Maryland, 20852

  • St. Charles Psychiatric Associates - Midwest Research Group

    Saint Charles, Missouri, 63301

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • BreakThrough Clinical Trials, LLC

    San Bernardino, California, 92408

  • Affiliated Research Institute

    San Diego, California, 92108

  • PCSD - Feighner Research

    San Diego, California, 92108

  • Clinical Innovations, Inc.

    San Diego, California, 92121

  • Sharp Mesa Vista Hospital

    San Diego, California, 92123'

  • Artemis Institute for Clinical Research

    San Diego, California, 92123

  • Neuropsychiatric Center of Orange County

    Santa Ana, California, 92701

  • ResearchOne, Inc.

    Scottsdale, Arizona, 85251

  • Summit Research Network (Seattle) LLC

    Seattle, Washington, 98125

  • Caliifornia Neuroscience Research Medical Group

    Sherman Oaks, California, 91403

  • Louisiana Clinical Research LLC

    Shreveport, Louisiana, 71101

  • Psyichiatric Medicine Associates, LLC

    Skokie, Illinois, 60076

  • Carman Research

    Smyrna, Georgia, 30080

  • Institute for Behavioral Medicine, LLC

    Smyrna, Georgia, 30080

  • Mid-America Clinical Research

    St Louis, Missouri, 63109

  • Mercy Health Research

    St Louis, Missouri, 63141

  • Meridien Research

    St. Petersburg, Florida, 33709

  • Comprehensive Clinical Development, Inc.

    St. Petersburg, Florida, 33716

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Neurology & Neuroscience Center of Ohio

    Toledo, Ohio, 43623

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

  • Northwest Indiana Center for Clinical Research

    Valparaiso, Indiana, 46383

  • Sleep and Behavior Medicine Institute

    Vernon Hills, Illinois, 60061

  • Adams Clinical Trials, LLC

    Watertown, Massachusetts, 02472

  • Independent Physician Consultants (dba IPC Research)

    Waukesha, Wisconsin, 53188

  • University Services

    West Chester, Pennsylvania, 19380

  • Janus Center for Psychiatric Research

    West Palm Beach, Florida, 33407

  • Sleep Medicine Centers of Western New York

    West Seneca, New York, 14224

  • Wharton Research Center, Inc.

    Wharton, Texas, 77488

  • Heartland Research Associates

    Wichita, Kansas, 67207

  • Grayline Clinical Drug Trials

    Wichita Falls, Texas, 76309

  • CRI Worldwide, LLC

    Willingboro, New Jersey, 08046

  • Clinical Research of Central Florida

    Winter Haven, Florida, 33880

  • Kolin Research Group

    Winter Park, Florida, 32789

Other trials in United States

Canada14 sites

  • Chatham-Kent Clinical Trials Research Centre

    Chatham, Ontario, N7M 5L9

  • Recherches Neuro-Hippocampe

    Gatineau, Quebec, J9A 1K7

  • Anxiety and Mood Disorder Center

    Mississauga, Ontario, L5M 4N4

  • Dr. Sunny Johnson Medical Corporation, Medican Research Associates

    Mississauga, Ontario, L5M 4N4

  • l'Hopital Louis H. Lafontaine

    Montreal, Quebec, H1N 3M5

  • A. K. Karan Holdings, Ltd.

    Oakville, Ontario, L6J 0B2

  • International Sleep Clinic, West Parry Sound Health Centre

    Parry Sound, Ontario, P2A 3A4

  • Dr. Alexander McIntyre Inc

    Penticton, British Columbia, V2A 4M4

  • Kells Medical Research Group Inc.

    Pointe-Claire, Quebec, H9R 4S3

  • Q & T Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1H 4J6

  • START Clinic for Mood and Anxiety Disorders

    Toronto, Ontario, M4W2N4

  • Sleep & Alertness Clinic

    Toronto, Ontario, M6J 3S3

  • Manna Research

    Toronto, Ontario, M9W 4L6

  • Dr. D. McIntosh & Dr. K. Kjernisted Clinical Research Inc.

    Vancouver, British Columbia, V6Z 2L4

Other trials in Canada

Germany10 sites

  • Facharzt fur Neurologie und Psychiatrie

    Berlin, 10245

  • Emovis GmbH

    Berlin, 10629

  • Complete Facharzt fur Neurologie und Psychiatrie

    Berlin, 13156

  • Private Practice Drs. Bitter/Schumann

    Bochum, 44805

  • ZSL Zentrum fuer medizinische Studien in Leipzig

    Leipzig, 04157

  • Complete Karlstr

    München, 80333

  • Studienzentrum Klinikum Nuernberg

    Nuremberg, 90419

  • Somni bene GmbH

    Schwerin, 19053

  • Gemeinschaftspraxis fur Neurologie und Psychiatrie

    Westerstede, 26655

  • Medizinisches Studienzentrum Wuerzburg

    Würzburg, 97070

Other trials in Germany

Czechia9 sites

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

    Brno, 602 00

  • Psychiatricka ambulance

    Brno, 615 00

  • Medicana s.r.o.

    Hořovice, 268 01

  • Supervize s.r.o.

    Kutná Hora, 284 01

  • Bialbi s.r.o.

    Litoměřice, 41201

  • Clintrial s.r.o.

    Prague, 120 00

  • Psychiatry Trial, s.r.o

    Prague, 15800

  • Medical Services Prague s.r.o.

    Prague, 160 00

  • Psychiatrie Ricany

    Říčany, Praha Vychod, 251 01

Other trials in Czechia

Poland9 sites

  • Prywatne Gabinety Lekarskie "Promedicus" Anna Agnieszka Tomczak

    Bialystok, 15-879

  • Zespol Opleki Zdrowotnej w Chelmole

    Chełmno, 86-200

  • Centrum Badan Klinicznych PI-House sp. z o. o.

    Gdansk, 80-546

  • Centrum Badan Klinicznych Pl-House

    Gdansk, 80-546

  • Klinika Chorob Psychicznych i Zaburzen Nerwicowych Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Klinika Chorob Psychicznych i Zaburzen Nerwicowych

    Gdansk

  • Centrum Psychiatrii i Psychoterapi

    Gorlice, 38-300

  • NZOZ Syntonia

    Kielce, 25-317

  • Samodzieiny Publiczny Zespol Zakladow Opieki Zdrowotnej w Zurominie

    Żuromin, 09-300

Other trials in Poland

Spain7 sites

  • Hospital Universitari de Bellvitge

    Barcelona, 08907

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • Hospital Fundacion de Alcorcon

    Madrid, 28922

  • Centro de Salud Mental II la Corredoria

    Oviedo, 33011

  • Centro de Salud Alamedilla Unidad de Salud Mental

    Salamanca, 37003

  • Complejo hospitalario de Zamora

    Zamora, 49021

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Chile4 sites

  • Psicomed Estudio Medicos

    Antofagasta, 1270244

  • Especialidades Medicas L y S

    Las Condes, Santiagio, 7560356

  • Centro de Estudios Clinicos (CEC)

    Providencia, Santiago Metropolitan, 7510186

  • Biomedica Research Group

    Providencia, Santiego, 7500710

Other trials in Chile

Estonia4 sites

  • Marienthal Psychiatry & Psychology Center of Mustamae

    Tallinn, 10617

  • North Estonia Medical Centre Foundation

    Tallinn

  • Jaanson & Laane Ou

    Tartu, 50406

  • Tartu University Hospital

    Tartu, 50417

Other trials in Estonia

Finland3 sites

  • ARTES Psykiatrinen Palvelukeskus Oy

    Helsinki, 00100

  • Satucon Oy / Privater

    Kuopio, 70100

  • Puutonin Psykiatripalvelu

    Turku, 20100

Other trials in Finland

Romania3 sites

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

    Bucharest, 041915'

  • Lorentina 2102 SRL

    Targoviste, 130081

  • Spitalui Clinic Judetean Mures

    Târgu Mureş, 540096

Other trials in Romania

South Africa3 sites

  • Cape Trial Centre

    Bellville, Cape Town, 7530

  • Flexivest Fourteen Research Centre

    Cape Town

  • Somerset West Clinical Research Unit

    Somerset West, Western Cape

Other trials in South Africa

Hungary2 sites

  • Semmelweis Egyetem Pszichiatrial es Pszichoterapias Klinkia

    Budapest

  • Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum

    Debrecen

Other trials in Hungary

Mexico2 sites

  • CRI Centro Regiomontano de Investigacion Clinica S.C

    Nuevo León, Monterrey, 64710

  • B&B Investigaciones Medicas, SC

    Sinaloa, Mazatian, 82126

Other trials in Mexico

Puerto Rico2 sites

  • Dharma Institute and Research Center

    San Juan, 00907

  • INSPIRA Clinical Research

    San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Open-label, Multicenter, 12-month Extension Safety and Tolerability Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Residual Symptoms or Inadequate Response Following Treatment With an Antidepressant

This study is an optional continuation of previous short-term adult major depressive disorder (MDD) augmentation studies. Patients may only take part in this long-term, open-label research study if they completed a previous double-blind MDD augmentation study using SPD489.

Being tested
SPD489 (Lisdexamfetamine dimesylate) + Antidepressant
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPD489 (Lisdexamfetamine dimesylate) + AntidepressantDrug

    Also called Vyvanse, LDX

    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

Study groups in NCT01436175
Study groupRoleWhat they receive
SPD489 + AntidepressantExperimentalNot described
Receives: Drug: SPD489 (Lisdexamfetamine dimesylate) + Antidepressant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Columbia-Suicide Severity Rating Scale (C-SSRS)

    C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviour during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.

    Measured: Week 5 up to Week 52/Early Termination(ET)

  2. Change From Baseline in Systolic Blood Pressure at Week 52

    Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).

    Measured: Baseline, Week 52/ET

  3. Change From Baseline in Diastolic Blood Pressure at Week 52

    Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).

    Measured: Baseline, Week 52/ET

  4. Change From Baseline in Pulse Rate at Week 52

    Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).

    Measured: Baseline, Week 52/ET

Secondary outcomes (18)

  1. Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET

    Designed to evaluate the extent to which illness symptoms impact a participant's life in 3 areas: work, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment. Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).

    Measured: Baseline, Week 52/ET

  2. Number of Participants With Improvement on Clinical Global Impressions - Global Improvement (CGI-I)

    Participants who did not have Clinical Global Impressions - Severity of Illness (CGI-S) assessed at Week 8 in the antecedent study should not have had CGI-I assessed in this study and were excluded from the summary of CGI-I. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.

    Measured: Week 52/ET

  3. Short Form-12 Health Survey Version 2 (SF-12V2)

    SF-12V2 is a multi-purpose, 7-item survey that measures 8 domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It is expressed by two summary measures (Aggregate Physical and Aggregate Mental) for which values can range from 0 to 100. A higher score is indicative of a better health state.

    Measured: Week 52/ET

  4. EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility

    Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses

    Measured: Week 52/ET

  5. EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care

    Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses

    Measured: Week 52/ET

  6. EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities

    Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses

    Measured: Week 52/ET

  7. EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort

    Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses

    Measured: Week 52/ET

  8. EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression

    Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses

    Measured: Week 52/ET

  9. EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Visual Analog Scale

    EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. EQ-5D-5L Visual Analog Scale score is numbered from 0 to 100, where a score of 100 is the best health a participant can imagine

    Measured: Week 52/ET

  10. Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)

    QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression. The QIDS-SR was only assessed in the SPD489-322 antecedent study. The QIDS-SR total score is calculated as the sum of the highest score on any 1 of Items 1-4, Item 5, the highest score on any 1 of Items 6-9, Items 10-14, the highest score on either Item 15 or 16.

    Measured: Week 52/ET

  11. Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)

    The Q-LES-Q-SF is a 16-item self-report questionnaire which evaluates general participant satisfaction with health, mood, relationships, functioning in daily life, and their treatment. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total raw score (summary scale score) was calculated by summing item scores 1 to 14 (total raw score range: 14 to 70). Item 15 (satisfaction with medication, raw score range: 1 to 5) and Item 16 (overall satisfaction and contentment; raw score range: 1 to 5) were stand-alone items. For reporting, summary scale, Item 15 and Item 16 raw scores were transformed into percentage maximum possible score which ranged from 0 to 100, where higher scores are indicative of greater enjoyment or satisfaction.

    Measured: Week 52/ET

  12. Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET

    CSFQ-14 is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning. Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).

    Measured: Baseline, Week 52/ET

  13. Amphetamine Cessation Symptom Assessment (ACSA) Total Score

    ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.

    Measured: Week 53

  14. Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)

    The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered the following questions: 1. Were you hospitalized in the past month, 2. Do you work for pay, 3. If you missed time at work last week, please note all the reasons why, 4. Would you say that the past week was typical, like the rest of the 3 weeks this month, in terms of your working hours, 5. Do you do volunteer work (VW), and 6. If you do not receive money for your work and do not participate in volunteer work, the reason is. Number of participants with response is reported.

    Measured: Week 52/ET

  15. PRUQ-MDD - Number of Days of Resource Utilization

    The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Number of nights in medical/surgical ward, number of nights in ICU, and number of days a participant received home care in the past month are reported.

    Measured: Week 52/ET

  16. PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)

    The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions - 1. How many times did you visit the following healthcare providers in the past month: Family doctor/primary care, Non-physician healthcare practitioner (NPHP), Psychiatrist/Psychologist/Counselor (PPC); 2. How many times did you take one of the tests, mentioned below, during the past month: Blood test, CT Scan, X Ray, Renal function, Thyroid function; and 3. How many times did you visit the hospital emergency room (ER), urgent care facility (UCF) or an after-hours clinic (AHC) in the past month. Number of events (visit to health care provider, visit to hospital facilities, and number of times a test was performed) are reported.

    Measured: Week 52/ET

  17. PRUQ-MDD - Number of Hours

    The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions - 1. How many hours do you usually work or would you usually be expected to work (hrs/week); 2. How many hours did you actually work last week; 3. On average, how many hours do you volunteer per week. Number of hours are reported.

    Measured: Week 52/ET

  18. PRUQ-MDD - Effect of Depressive Symptoms

    The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions on a 0 to 10 point scale - 1. During past week, how much did depressive symptoms affect work productivity; 2. During past week, how much did depressive symptoms affect regular non-work daily activities. Higher scores indicates more effect of depressive symptoms on work productivity and non-work daily activities.

    Measured: Week 52/ET

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2011 (estimated)
  2. Study start27 Feb 2012
  3. Primary completion27 Mar 2014
  4. Study completion27 Mar 2014

Why it stopped: SPD489 failed to demonstrate a benefit as adjunctive treatment to antidepressants. Termination was not related to any new safety findings.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,570 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01436175
Sponsor's protocol ID
SPD489-329
Other IDs
2011-003019-47
Status last verified
Jun 2021
First submitted
15 Sep 2011
Last updated
14 Jun 2021

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SPD489 (Lisdexamfetamine dimesylate) + Antidepressant in people with Major Depressive Disorder, run by Shire at 212 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 212 sites in United States, Canada, Germany, Czechia, Poland and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Columbia-Suicide Severity Rating Scale (C-SSRS) (time frame: Week 5 up to Week 52/Early Termination(ET)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01436175.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.

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