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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01436175
• Other study ID #: SPD489-329
• Secondary ID: 2011-003019-47
• Status: Terminated
• Phase: Phase 3
• Start date: February 27, 2012
• Est. completion date: March 27, 2014

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1570
• Est. completion date: March 27, 2014
• Est. primary completion date: March 27, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Canada	Chatham-Kent Clinical Trials Research Centre	Chatham	Ontario
Canada	Recherches Neuro-Hippocampe	Gatineau	Quebec
Canada	Anxiety and Mood Disorder Center	Mississauga	Ontario
Canada	Dr. Sunny Johnson Medical Corporation, Medican Research Associates	Mississauga	Ontario
Canada	l'Hopital Louis H. Lafontaine	Montreal	Quebec
Canada	A. K. Karan Holdings, Ltd.	Oakville	Ontario
Canada	International Sleep Clinic, West Parry Sound Health Centre	Parry Sound	Ontario
Canada	Dr. Alexander McIntyre Inc	Penticton	British Columbia
Canada	Kells Medical Research Group Inc.	Pointe Claire	Quebec
Canada	Q & T Research Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Manna Research	Toronto	Ontario
Canada	Sleep & Alertness Clinic	Toronto	Ontario
Canada	START Clinic for Mood and Anxiety Disorders	Toronto	Ontario
Canada	Dr. D. McIntosh & Dr. K. Kjernisted Clinical Research Inc.	Vancouver	British Columbia
Chile	Psicomed Estudio Medicos	Antofagasta
Chile	Especialidades Medicas L y S	Las Condes	Santiagio
Chile	Biomedica Research Group	Providencia	Santiego
Chile	Centro de Estudios Clinicos (CEC)	Providencia	Santiago
Czechia	Psychiatricka ambulance	Brno
Czechia	Saint Anne s.r.o., Psychiatricka ambulance	Brno
Czechia	Medicana s.r.o.	Horovice
Czechia	Supervize s.r.o.	Kutna Hora
Czechia	Bialbi s.r.o.	Litomerice
Czechia	Medical Services Prague s.r.o.	Prague
Czechia	Psychiatry Trial, s.r.o	Prague
Czechia	Clintrial s.r.o.	Prague 10
Czechia	Psychiatrie Ricany	Ricany	Praha Vychod
Estonia	Marienthal Psychiatry & Psychology Center of Mustamae	Tallinn
Estonia	North Estonia Medical Centre Foundation	Tallinn
Estonia	Jaanson & Laane Ou	Tartu
Estonia	Tartu University Hospital	Tartu
Finland	ARTES Psykiatrinen Palvelukeskus Oy	Helsinki
Finland	Satucon Oy / Privater	Kuopio
Finland	Puutonin Psykiatripalvelu	Turku
Germany	Complete Facharzt fur Neurologie und Psychiatrie	Berlin
Germany	Emovis GmbH	Berlin
Germany	Facharzt fur Neurologie und Psychiatrie	Berlin
Germany	Private Practice Drs. Bitter/Schumann	Bochum
Germany	ZSL Zentrum fuer medizinische Studien in Leipzig	Leipzig
Germany	Complete Karlstr	Munchen
Germany	Studienzentrum Klinikum Nuernberg	Nuernberg
Germany	Somni bene GmbH	Schwerin
Germany	Gemeinschaftspraxis fur Neurologie und Psychiatrie	Westerstede
Germany	Medizinisches Studienzentrum Wuerzburg	Wuerzburg
Hungary	Semmelweis Egyetem Pszichiatrial es Pszichoterapias Klinkia	Budapest
Hungary	Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum	Debrecen
Mexico	CRI Centro Regiomontano de Investigacion Clinica S.C	Nuevo Leon	Monterrey
Mexico	B&B Investigaciones Medicas, SC	Sinaloa	Mazatian
Poland	Prywatne Gabinety Lekarskie "Promedicus" Anna Agnieszka Tomczak	Bialystok
Poland	Zespol Opleki Zdrowotnej w Chelmole	Chelmno
Poland	Centrum Badan Klinicznych PI-House sp. z o. o.	Gdansk
Poland	Centrum Badan Klinicznych Pl-House	Gdansk
Poland	Klinika Chorob Psychicznych i Zaburzen Nerwicowych	Gdansk
Poland	Klinika Chorob Psychicznych i Zaburzen Nerwicowych Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Centrum Psychiatrii i Psychoterapi	Gorlice
Poland	NZOZ Syntonia	Kielce
Poland	Samodzieiny Publiczny Zespol Zakladow Opieki Zdrowotnej w Zurominie	Zuromin
Puerto Rico	Dharma Institute and Research Center	San Juan
Puerto Rico	INSPIRA Clinical Research	San Juan
Romania	Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia" Sectia Clinica Psihiatrie I	Bucuresti
Romania	Lorentina 2102 SRL	Targoviste
Romania	Spitalui Clinic Judetean Mures	Targu Mures
South Africa	Cape Trial Centre	Bellville	Cape Town
South Africa	Flexivest Fourteen Research Centre	Cape Town
South Africa	Somerset West Clinical Research Unit	Somerset West	Western Cape
Spain	Hospital Universitari de Bellvitge	Barcelona
Spain	Hospital Fundacion de Alcorcon	Madrid
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Centro de Salud Mental II la Corredoria	Oviedo
Spain	Centro de Salud Alamedilla Unidad de Salud Mental	Salamanca
Spain	Complejo hospitalario de Zamora	Zamora
Spain	Hospital Clinico Universitario Lozano Blesa	Zaragoza
United States	Albuquerque Neuroscience Inc.	Albuquerque	New Mexico
United States	Lehigh Center for Clinical Research	Allentown	Pennsylvania
United States	South Coast Clinical Trials, Inc.	Anaheim	California
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Atlanta Institute of Medicine & Research	Atlanta	Georgia
United States	FutureSearch Clinical Trials, LP	Austin	Texas
United States	Pharmasite Research, Inc.	Baltimore	Maryland
United States	Northcoast Clinical Trials	Beachwood	Ohio
United States	Birmingham Research Group	Birmingham	Alabama
United States	Florida Clinical Research Center, LLC	Bradenton	Florida
United States	Paramount Clinical Research	Bridgeville	Pennsylvania
United States	Montefiore Medical Center	Bronx	New York
United States	Brooklyn Medical Institutes	Brooklyn	New York
United States	American Neuropsychiatric Research, Inc.	Carson	California
United States	Center For Emotional Fitness	Cherry Hill	New Jersey
United States	Rush University Medical Center	Chicago	Illinois
United States	Catalina Research Institute, LLC	Chino	California
United States	Community Research, Inc.	Cincinnati	Ohio
United States	Ericksen Research and Development	Clinton	Utah
United States	MCB Clinical Research Centers	Colorado Springs	Colorado
United States	Shanti Clinical Trials	Colton	California
United States	Ohio State University Department of Psychiatry	Columbus	Ohio
United States	CNS Clinical Research Group	Coral Springs	Florida
United States	ATP Clinical Research	Costa Mesa	California
United States	Clinical Innovation, Inc.	Costa Mesa	California
United States	Connecticut Clinical Research	Cromwell	Connecticut
United States	Future Search Trials of Dallas, LP	Dallas	Texas
United States	KRK Medical Research	Dallas	Texas
United States	Pillar Clinical Research, LLC	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Western Affiliated Research Institute	Denver	Colorado
United States	Diligent Clinical Trials	Downey	California
United States	Triangle Neuropsyhiatry	Durham	North Carolina
United States	Rhode Island Mood & Memory Research Institute	East Providence	Rhode Island
United States	Synergy Clinical Research Center of Escondido	Escondido	California
United States	MCM Clinical Research LLC	Florence	Kentucky
United States	Gulfcoast Clinical Research Center	Fort Myers	Florida
United States	Emerald Coast Mood & Memory, PA	Fort Walton Beach	Florida
United States	Psychiatric Consultants, PC	Franklin	Tennessee
United States	Comprehensive Clinical Development, Inc.	Fresh Meadows	New York
United States	Bay Area Clinical Services	Friendswood	Texas
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Potomac Grove Clinical Research Center	Gaithersburg	Maryland
United States	Collaborative Neuroscience Network, Inc.	Garden Grove	California
United States	Comprehensive Psyichatric Associates	Gladstone	Missouri
United States	Geriatric and Adult Psychiatry, LLC	Hamden	Connecticut
United States	Institute of Living - Hartford Hospital	Hartford	Connecticut
United States	Clinical Trials of America	Hickory	North Carolina
United States	Alexian Brothers Center for Psychiatric Research	Hoffman Estates	Illinois
United States	Houston Clinical Trials, LLC	Houston	Texas
United States	Davis Clinic	Indianapolis	Indiana
United States	Irvine Center For Clinical Research	Irvine	California
United States	UC, Irvine Child Development Center	Irvine	California
United States	Amit Vijapura MD	Jacksonville	Florida
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	The Center for Pharmaceutical Research PC	Kansas City	Missouri
United States	Omega Clinical Trials, LLC	La Habra	California
United States	Psychiatric Associates	Lake City	Florida
United States	Clinical Research Consortium	Las Vegas	Nevada
United States	Premier Psychiatric Research Institute	Lincoln	Nebraska
United States	Arkansas Psychiatric Clinical Research Trials, P.A.	Little Rock	Arkansas
United States	Semel Institute for Neuroscience & Human Behavior at UCLA	Los Angeles	California
United States	Florida Clinical Research Center, LLC	Maitland	Florida
United States	Lindner Center for Hope	Mason	Ohio
United States	Suburban Research Associates	Media	Pennsylvania
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	Research Strategies of Memphis, LLC	Memphis	Tennessee
United States	North Star Medical Research, LLC	Middleburg Heights	Ohio
United States	Dean Foundation for Health, Research, and Education	Middleton	Wisconsin
United States	Bioscience Research LLC	Mount Kisco	New York
United States	Clinical Research Associates, Inc.	Nashville	Tennessee
United States	The Hospital of Central Connecticut	New Britain	Connecticut
United States	Suncoast Clinical Research	New Port Richey	Florida
United States	Clinilabs, Inc.	New York	New York
United States	Fieve Clinical Research	New York	New York
United States	Medical & Behavioral Health Research, PC	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	Pedia Research, LLC	Newburgh	Indiana
United States	Medical University of South Carolina, Anxiety Disorders Program	North Charleston	South Carolina
United States	Fidelity Clinical Research Inc	North Miami	Florida
United States	Scientific Clinical Research Inc.	North Miami	Florida
United States	Private Practice - Howard J. Ilivicky	O'Fallon	Missouri
United States	American Medical Research, Inc.	Oakbrook Terrace	Illinois
United States	Pacific Research Partners	Oakland	California
United States	North County Clinical Research	Oceanside	California
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Sooner Clinical Research	Oklahoma City	Oklahoma
United States	SP Research, PPC dba Oklahoma Clinical Research Center	Oklahoma City	Oklahoma
United States	Ali A. Kashfi, MD, PA	Orlando	Florida
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Compass Research, LLC	Orlando	Florida
United States	Pedia Research, LLC	Owensboro	Kentucky
United States	Pasadena Research Institute, LLC	Pasadena	California
United States	Belmont Center for Comprehensive Treatment	Philadelphia	Pennsylvania
United States	CRI Worldwide LLC	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	UPMC Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania
United States	Summit Research Network (Oregon) Inc.	Portland	Oregon
United States	Clinical Trials Technology, Inc.	Prairie Village	Kansas
United States	Dr. Richard Weisler	Raleigh	North Carolina
United States	Anderson Clinical Research	Redlands	California
United States	Alliance Research Group	Richmond	Virginia
United States	Office of Marc Hertzman, MD	Rockville	Maryland
United States	St. Charles Psychiatric Associates - Midwest Research Group	Saint Charles	Missouri
United States	Mercy Health Research	Saint Louis	Missouri
United States	Mid-America Clinical Research	Saint Louis	Missouri
United States	Comprehensive Clinical Development, Inc.	Saint Petersburg	Florida
United States	Meridien Research	Saint Petersburg	Florida
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	BreakThrough Clinical Trials, LLC	San Bernardino	California
United States	Affiliated Research Institute	San Diego	California
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Clinical Innovations, Inc.	San Diego	California
United States	PCSD - Feighner Research	San Diego	California
United States	Sharp Mesa Vista Hospital	San Diego	California
United States	Neuropsychiatric Center of Orange County	Santa Ana	California
United States	ResearchOne, Inc.	Scottsdale	Arizona
United States	Summit Research Network (Seattle) LLC	Seattle	Washington
United States	Caliifornia Neuroscience Research Medical Group	Sherman Oaks	California
United States	Louisiana Clinical Research LLC	Shreveport	Louisiana
United States	Psyichiatric Medicine Associates, LLC	Skokie	Illinois
United States	Carman Research	Smyrna	Georgia
United States	Institute for Behavioral Medicine, LLC	Smyrna	Georgia
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Stedman Clinical Trials	Tampa	Florida
United States	Neurology & Neuroscience Center of Ohio	Toledo	Ohio
United States	Bio Behavioral Health	Toms River	New Jersey
United States	Northwest Indiana Center for Clinical Research	Valparaiso	Indiana
United States	Sleep and Behavior Medicine Institute	Vernon Hills	Illinois
United States	Adams Clinical Trials, LLC	Watertown	Massachusetts
United States	Independent Physician Consultants (dba IPC Research)	Waukesha	Wisconsin
United States	University Services	West Chester	Pennsylvania
United States	Janus Center for Psychiatric Research	West Palm Beach	Florida
United States	Sleep Medicine Centers of Western New York	West Seneca	New York
United States	Wharton Research Center, Inc.	Wharton	Texas
United States	Heartland Research Associates	Wichita	Kansas
United States	Grayline Clinical Drug Trials	Wichita Falls	Texas
United States	CRI Worldwide, LLC	Willingboro	New Jersey
United States	Clinical Research of Central Florida	Winter Haven	Florida
United States	Kolin Research Group	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

United States,  Canada,  Chile,  Czechia,  Estonia,  Finland,  Germany,  Hungary,  Mexico,  Poland,  Puerto Rico,  Romania,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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