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

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.

Study Overview

• Status: Terminated
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: SPD489 (Lisdexamfetamine dimesylate) + Antidepressant

• Study Type: Interventional
• Enrollment (Actual): 1570
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Penticton, British Columbia, Canada, V2A 4M4
      • Dr. Alexander McIntyre Inc
    • Vancouver, British Columbia, Canada, V6Z 2L4
      • Dr. D. McIntosh & Dr. K. Kjernisted Clinical Research Inc.
  • Ontario
    • Chatham, Ontario, Canada, N7M 5L9
      • Chatham-Kent Clinical Trials Research Centre
    • Mississauga, Ontario, Canada, L5M 4N4
      • Anxiety and Mood Disorder Center
    • Mississauga, Ontario, Canada, L5M 4N4
      • Dr. Sunny Johnson Medical Corporation, Medican Research Associates
    • Oakville, Ontario, Canada, L6J 0B2
      • A. K. Karan Holdings, Ltd.
    • Parry Sound, Ontario, Canada, P2A 3A4
      • International Sleep Clinic, West Parry Sound Health Centre
    • Toronto, Ontario, Canada, M9W 4L6
      • Manna Research
    • Toronto, Ontario, Canada, M4W2N4
      • START Clinic for Mood and Anxiety Disorders
    • Toronto, Ontario, Canada, M6J 3S3
      • Sleep & Alertness Clinic
  • Quebec
    • Gatineau, Quebec, Canada, J9A 1K7
      • Recherches Neuro-Hippocampe
    • Montreal, Quebec, Canada, H1N 3M5
      • l'Hopital Louis H. Lafontaine
    • Pointe Claire, Quebec, Canada, H9R 4S3
      • Kells Medical Research Group Inc.
    • Sherbrooke, Quebec, Canada, J1H 4J6
      • Q & T Research Sherbrooke Inc.
• Chile
  • Antofagasta, Chile, 1270244
    • Psicomed Estudio Medicos
  • Santiagio
    • Las Condes, Santiagio, Chile, 7560356
      • Especialidades Medicas L y S
  • Santiago
    • Providencia, Santiago, Chile, 7510186
      • Centro de Estudios Clinicos (CEC)
  • Santiego
    • Providencia, Santiego, Chile, 7500710
      • Biomedica Research Group
• Czechia
  • Brno, Czechia, 615 00
    • Psychiatricka ambulance
  • Brno, Czechia, 602 00
    • Saint Anne s.r.o., Psychiatricka ambulance
  • Horovice, Czechia, 268 01
    • Medicana s.r.o.
  • Kutna Hora, Czechia, 284 01
    • Supervize s.r.o.
  • Litomerice, Czechia, 41201
    • Bialbi s.r.o.
  • Prague, Czechia, 15800
    • Psychiatry Trial, s.r.o
  • Prague, Czechia, 160 00
    • Medical Services Prague s.r.o.
  • Prague 10, Czechia, 120 00
    • Clintrial s.r.o.
  • Praha Vychod
    • Ricany, Praha Vychod, Czechia, 251 01
      • Psychiatrie Ricany
• Estonia
  • Tallinn, Estonia
    • North Estonia Medical Centre Foundation
  • Tallinn, Estonia, 10617
    • Marienthal Psychiatry & Psychology Center of Mustamae
  • Tartu, Estonia, 50417
    • Tartu University Hospital
  • Tartu, Estonia, 50406
    • Jaanson & Laane Ou
• Finland
  • Helsinki, Finland, 00100
    • ARTES Psykiatrinen Palvelukeskus Oy
  • Kuopio, Finland, 70100
    • Satucon Oy / Privater
  • Turku, Finland, 20100
    • Puutonin Psykiatripalvelu
• Germany
  • Berlin, Germany, 10629
    • emovis GmbH
  • Berlin, Germany, 10245
    • Facharzt fur Neurologie und Psychiatrie
  • Berlin, Germany, 13156
    • Complete Facharzt fur Neurologie und Psychiatrie
  • Bochum, Germany, 44805
    • Private Practice Drs. Bitter/Schumann
  • Leipzig, Germany, 04157
    • ZSL Zentrum fuer medizinische Studien in Leipzig
  • Munchen, Germany, 80333
    • Complete Karlstr
  • Nuernberg, Germany, 90419
    • Studienzentrum Klinikum Nuernberg
  • Schwerin, Germany, 19053
    • Somni Bene GmbH
  • Westerstede, Germany, 26655
    • Gemeinschaftspraxis fur Neurologie und Psychiatrie
  • Wuerzburg, Germany, 97070
    • Medizinisches Studienzentrum Wuerzburg
• Hungary
  • Budapest, Hungary
    • Semmelweis Egyetem Pszichiatrial es Pszichoterapias Klinkia
  • Debrecen, Hungary
    • Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum
• Mexico
  • Mazatian
    • Sinaloa, Mazatian, Mexico, 82126
      • B&B Investigaciones Medicas, SC
  • Monterrey
    • Nuevo Leon, Monterrey, Mexico, 64710
      • CRI Centro Regiomontano de Investigacion Clinica S.C
• Poland
  • Bialystok, Poland, 15-879
    • Prywatne Gabinety Lekarskie "Promedicus" Anna Agnieszka Tomczak
  • Chelmno, Poland, 86-200
    • Zespol Opleki Zdrowotnej w Chelmole
  • Gdansk, Poland, 80-546
    • Centrum Badan Klinicznych Pi-house Sp. Z O. O.
  • Gdansk, Poland, 80-546
    • Centrum Badan Klinicznych Pl-House
  • Gdansk, Poland, 80-952
    • Klinika Chorob Psychicznych i Zaburzen Nerwicowych Uniwersyteckie Centrum Kliniczne
  • Gdansk, Poland
    • Klinika Chorob Psychicznych i Zaburzen Nerwicowych
  • Gorlice, Poland, 38-300
    • Centrum Psychiatrii i Psychoterapi
  • Kielce, Poland, 25-317
    • NZOZ Syntonia
  • Zuromin, Poland, 09-300
    • Samodzieiny Publiczny Zespol Zakladow Opieki Zdrowotnej w Zurominie
• Puerto Rico
  • San Juan, Puerto Rico, 00918
    • INSPIRA Clinical Research
  • San Juan, Puerto Rico, 00907
    • Dharma Institute and Research Center
• Romania
  • Bucuresti, Romania, 041915'
    • Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia" Sectia Clinica Psihiatrie I
  • Targoviste, Romania, 130081
    • Lorentina 2102 SRL
  • Targu Mures, Romania, 540096
    • Spitalui Clinic Judetean Mures
• South Africa
  • Cape Town, South Africa
    • Flexivest Fourteen Research Centre
  • Cape Town
    • Bellville, Cape Town, South Africa, 7530
      • Cape Trial Centre
  • Western Cape
    • Somerset West, Western Cape, South Africa
      • Somerset West Clinical Research Unit
• Spain
  • Barcelona, Spain, 08907
    • Hospital Universitari de Bellvitge
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor
  • Madrid, Spain, 28922
    • Hospital Fundación de Alcorcón
  • Oviedo, Spain, 33011
    • Centro de Salud Mental II la Corredoria
  • Salamanca, Spain, 37003
    • Centro de Salud Alamedilla Unidad de Salud Mental
  • Zamora, Spain, 49021
    • Complejo hospitalario de Zamora
  • Zaragoza, Spain, 50009
    • Hospital Clinico Universitario Lozano Blesa
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Birmingham Research Group
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • ResearchOne, Inc.
  • Arkansas
    • Little Rock, Arkansas, United States, 72223
      • Arkansas Psychiatric Clinical Research Trials, P.A.
  • California
    • Anaheim, California, United States, 92804
      • South Coast Clinical Trials, Inc.
    • Carson, California, United States, 90746
      • American Neuropsychiatric Research, Inc.
    • Chino, California, United States, 91710
      • Catalina Research Institute, LLC
    • Colton, California, United States, 92324
      • Shanti Clinical Trials
    • Costa Mesa, California, United States, 92626
      • ATP Clinical Research
    • Costa Mesa, California, United States, 92626
      • Clinical Innovation, Inc.
    • Downey, California, United States, 90241
      • Diligent Clinical Trials
    • Escondido, California, United States, 92025
      • Synergy Clinical Research Center Of Escondido
    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Network, Inc.
    • Irvine, California, United States, 92618
      • Irvine Center for Clinical Research
    • Irvine, California, United States, 92612
      • UC, Irvine Child Development Center
    • La Habra, California, United States, 90631
      • Omega Clinical Trials, LLC
    • Los Angeles, California, United States, 90024
      • Semel Institute for Neuroscience & Human Behavior at UCLA
    • Oakland, California, United States, 94612
      • Pacific Research Partners
    • Oceanside, California, United States, 92066
      • North County Clinical Research
    • Pasadena, California, United States, 91106
      • Pasadena Research Institute, LLC
    • Redlands, California, United States, 92374
      • Anderson Clinical Research
    • San Bernardino, California, United States, 92408
      • BreakThrough Clinical Trials, LLC
    • San Diego, California, United States, 92108
      • PCSD - Feighner Research
    • San Diego, California, United States, 92123
      • Artemis Institute for Clinical Research
    • San Diego, California, United States, 92108
      • Affiliated Research Institute
    • San Diego, California, United States, 92121
      • Clinical Innovations, Inc.
    • San Diego, California, United States, 92123'
      • Sharp Mesa Vista Hospital
    • Santa Ana, California, United States, 92701
      • Neuropsychiatric Center of Orange County
    • Sherman Oaks, California, United States, 91403
      • Caliifornia Neuroscience Research Medical Group
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • MCB Clinical Research Centers
    • Denver, Colorado, United States, 80209
      • Western Affiliated Research Institute
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • Connecticut Clinical Research
    • Hamden, Connecticut, United States, 06518
      • Geriatric and Adult Psychiatry, LLC
    • Hartford, Connecticut, United States, 06106
      • Institute of Living - Hartford Hospital
    • New Britain, Connecticut, United States, 06050
      • The Hospital of Central Connecticut
  • Florida
    • Bradenton, Florida, United States, 34201
      • Florida Clinical Research Center, LLC
    • Coral Springs, Florida, United States, 33067
      • CNS Clinical Research Group
    • Fort Myers, Florida, United States, 33912
      • Gulfcoast Clinical Research Center
    • Fort Walton Beach, Florida, United States, 32547
      • Emerald Coast Mood & Memory, PA
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Jacksonville, Florida, United States, 32216
      • Clinical Neuroscience Solutions, Inc.
    • Jacksonville, Florida, United States, 32256
      • Amit Vijapura MD
    • Lake City, Florida, United States, 32025
      • Psychiatric Associates
    • Maitland, Florida, United States, 32751
      • Florida Clinical Research Center, LLC
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research
    • North Miami, Florida, United States, 33161
      • Scientific Clinical Research Inc.
    • North Miami, Florida, United States, 33161
      • Fidelity Clinical Research Inc
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • Orlando, Florida, United States, 32806
      • Clinical Neuroscience Solutions, Inc.
    • Orlando, Florida, United States, 32889
      • Ali A. Kashfi, MD, PA
    • Saint Petersburg, Florida, United States, 33709
      • Meridien Research
    • Saint Petersburg, Florida, United States, 33716
      • Comprehensive Clinical Development, Inc.
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
    • West Palm Beach, Florida, United States, 33407
      • Janus Center For Psychiatric Research
    • Winter Haven, Florida, United States, 33880
      • Clinical Research of Central Florida
    • Winter Park, Florida, United States, 32789
      • Kolin Research Group
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Atlanta Center for Medical Research
    • Atlanta, Georgia, United States, 30328
      • Atlanta Institute of Medicine & Research
    • Smyrna, Georgia, United States, 30080
      • Carman Research
    • Smyrna, Georgia, United States, 30080
      • Institute For Behavioral Medicine, Llc
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Hoffman Estates, Illinois, United States, 60169
      • Alexian Brothers Center for Psychiatric Research
    • Oakbrook Terrace, Illinois, United States, 60523
      • American Medical Research, Inc.
    • Skokie, Illinois, United States, 60076
      • Psyichiatric Medicine Associates, LLC
    • Vernon Hills, Illinois, United States, 60061
      • Sleep and Behavior Medicine Institute
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Davis Clinic
    • Newburgh, Indiana, United States, 47630
      • Pedia Research, LLC
    • Valparaiso, Indiana, United States, 46383
      • Northwest Indiana Center for Clinical Research
  • Kansas
    • Prairie Village, Kansas, United States, 66206
      • Clinical Trials Technology, Inc.
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates
  • Kentucky
    • Florence, Kentucky, United States, 41042
      • MCM Clinical Research LLC
    • Owensboro, Kentucky, United States, 42301
      • Pedia Research, LLC
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Louisiana Clinical Research LLC
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Pharmasite Research, Inc.
    • Gaithersburg, Maryland, United States, 20877
      • Potomac Grove Clinical Research Center
    • Rockville, Maryland, United States, 20852
      • Office of Marc Hertzman, MD
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
      • Adams Clinical Trials, LLC
  • Missouri
    • Gladstone, Missouri, United States, 64118
      • Comprehensive Psyichatric Associates
    • Kansas City, Missouri, United States, 64114
      • The Center For Pharmaceutical Research PC
    • O'Fallon, Missouri, United States, 63368
      • Private Practice - Howard J. Ilivicky
    • Saint Charles, Missouri, United States, 63301
      • St. Charles Psychiatric Associates - Midwest Research Group
    • Saint Louis, Missouri, United States, 63141
      • Mercy Health Research
    • Saint Louis, Missouri, United States, 63109
      • Mid-America Clinical Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Premier Psychiatric Research Institute
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Clinical Research Consortium
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Center for Emotional Fitness
    • Toms River, New Jersey, United States, 08755
      • Bio Behavioral Health
    • Willingboro, New Jersey, United States, 08046
      • CRI Worldwide, LLC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Albuquerque Neuroscience Inc.
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Brooklyn, New York, United States, 11214
      • Brooklyn Medical Institutes
    • Fresh Meadows, New York, United States, 11366
      • Comprehensive Clinical Development, Inc.
    • Mount Kisco, New York, United States, 10549
      • Bioscience Research LLC
    • New York, New York, United States, 10019
      • Clinilabs, Inc.
    • New York, New York, United States, 10023
      • Medical & Behavioral Health Research, PC
    • New York, New York, United States, 11029
      • Mount Sinai School of Medicine
    • New York, New York, United States, 10075
      • Fieve Clinical Research
    • Staten Island, New York, United States, 10312
      • Richmond Behavioral Associates
    • West Seneca, New York, United States, 14224
      • Sleep Medicine Centers of Western New York
  • North Carolina
    • Durham, North Carolina, United States, 27707
      • Triangle Neuropsyhiatry
    • Hickory, North Carolina, United States, 28601
      • Clinical Trials of America
    • Raleigh, North Carolina, United States, 27609
      • Dr. Richard Weisler
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Northcoast Clinical Trials
    • Cincinnati, Ohio, United States, 45227
      • Community Research, Inc.
    • Columbus, Ohio, United States, 43210
      • Ohio State University Department of Psychiatry
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
    • Mason, Ohio, United States, 45040
      • Lindner Center for Hope
    • Middleburg Heights, Ohio, United States, 44130
      • North Star Medical Research, LLC
    • Toledo, Ohio, United States, 43623
      • Neurology & Neuroscience Center Of Ohio
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research Company
    • Oklahoma City, Oklahoma, United States, 73112
      • Sooner Clinical Research
    • Oklahoma City, Oklahoma, United States, 73112
      • SP Research, PPC dba Oklahoma Clinical Research Center
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network (Oregon) Inc.
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Lehigh Center for Clinical Research
    • Bridgeville, Pennsylvania, United States, 15017
      • Paramount Clinical Research
    • Media, Pennsylvania, United States, 19063
      • Suburban Research Associates
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States, 19139
      • CRI Worldwide LLC
    • Philadelphia, Pennsylvania, United States, 19131
      • Belmont Center For Comprehensive Treatment
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Western Psychiatric Institute and Clinic
    • West Chester, Pennsylvania, United States, 19380
      • University Services
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Rhode Island Mood & Memory Research Institute
  • South Carolina
    • North Charleston, South Carolina, United States, 29406
      • Medical University of South Carolina, Anxiety Disorders Program
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Psychiatric Consultants, PC
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc.
    • Memphis, Tennessee, United States, 38119
      • Research Strategies of Memphis, LLC
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates, Inc.
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Clinical Trials, LP
    • Dallas, Texas, United States, 75230
      • KRK Medical Research
    • Dallas, Texas, United States, 75243
      • Pillar Clinical Research, LLC
    • Dallas, Texas, United States, 75231
      • Future Search Trials of Dallas, LP
    • Friendswood, Texas, United States, 77546
      • Bay Area Clinical Services
    • Houston, Texas, United States, 77098
      • Houston Clinical Trials, LLC
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
    • Wharton, Texas, United States, 77488
      • Wharton Research Center, Inc.
    • Wichita Falls, Texas, United States, 76309
      • Grayline Clinical Drug Trials
  • Utah
    • Clinton, Utah, United States, 84015
      • Ericksen Research and Development
  • Virginia
    • Richmond, Virginia, United States, 23236
      • Alliance Research Group
  • Washington
    • Seattle, Washington, United States, 98125
      • Summit Research Network (Seattle) Llc
  • Wisconsin
    • Middleton, Wisconsin, United States, 53562
      • Dean Foundation for Health, Research, and Education
    • Waukesha, Wisconsin, United States, 53188
      • Independent Physician Consultants (dba IPC Research)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SPD489 + Antidepressant	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; Other Names: Vyvanse, LDX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 5 up to Week 52/Early Termination(ET)
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]).	Baseline, Week 52/ET
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]).	Baseline, Week 52/ET
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]).	Baseline, Week 52/ET

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]).	Baseline, Week 52/ET
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.	Week 52/ET
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.	Week 52/ET
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	Week 52/ET
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	Week 52/ET
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	Week 52/ET
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	Week 52/ET
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	Week 52/ET
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	Week 52/ET
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.	Week 52/ET
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.	Week 52/ET
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]).	Baseline, Week 52/ET
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.	Week 53
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.	Week 52/ET
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.	Week 52/ET
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.	Week 52/ET
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.	Week 52/ET
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.	Week 52/ET

Collaborators and Investigators

• Sponsor: Shire

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 27, 2012
• Primary Completion (ACTUAL): March 27, 2014
• Study Completion (ACTUAL): March 27, 2014

Study Registration Dates

• First Submitted: September 15, 2011
• First Submitted That Met QC Criteria: September 16, 2011
• First Posted (ESTIMATE): September 19, 2011

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Lisdexamfetamine Dimesylate; Antidepressive Agents
• Other Study ID Numbers: SPD489-329; 2011-003019-47 (EUDRACT_NUMBER)