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

Primary Purpose

Major Depressive Disorder

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SPD489 (Lisdexamfetamine dimesylate) + Antidepressant
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Birmingham Research Group
  • ResearchOne, Inc.
  • Arkansas Psychiatric Clinical Research Trials, P.A.
  • South Coast Clinical Trials, Inc.
  • American Neuropsychiatric Research, Inc.
  • Catalina Research Institute, LLC
  • Shanti Clinical Trials
  • ATP Clinical Research
  • Clinical Innovation, Inc.
  • Diligent Clinical Trials
  • Synergy Clinical Research Center of Escondido
  • Collaborative Neuroscience Network, Inc.
  • UC, Irvine Child Development Center
  • Irvine Center For Clinical Research
  • Omega Clinical Trials, LLC
  • Semel Institute for Neuroscience & Human Behavior at UCLA
  • Pacific Research Partners
  • North County Clinical Research
  • Pasadena Research Institute, LLC
  • Anderson Clinical Research
  • BreakThrough Clinical Trials, LLC
  • Affiliated Research Institute
  • PCSD - Feighner Research
  • Clinical Innovations, Inc.
  • Sharp Mesa Vista Hospital
  • Artemis Institute for Clinical Research
  • Neuropsychiatric Center of Orange County
  • Caliifornia Neuroscience Research Medical Group
  • MCB Clinical Research Centers
  • Western Affiliated Research Institute
  • Connecticut Clinical Research
  • Geriatric and Adult Psychiatry, LLC
  • Institute of Living - Hartford Hospital
  • The Hospital of Central Connecticut
  • Florida Clinical Research Center, LLC
  • CNS Clinical Research Group
  • Gulfcoast Clinical Research Center
  • Emerald Coast Mood & Memory, PA
  • Sarkis Clinical Trials
  • Clinical Neuroscience Solutions, Inc.
  • Amit Vijapura MD
  • Psychiatric Associates
  • Florida Clinical Research Center, LLC
  • Suncoast Clinical Research
  • Fidelity Clinical Research Inc
  • Scientific Clinical Research Inc.
  • Clinical Neuroscience Solutions, Inc.
  • Compass Research, LLC
  • Ali A. Kashfi, MD, PA
  • Meridien Research
  • Comprehensive Clinical Development, Inc.
  • Stedman Clinical Trials
  • Janus Center for Psychiatric Research
  • Clinical Research of Central Florida
  • Kolin Research Group
  • Atlanta Center for Medical Research
  • Atlanta Institute of Medicine & Research
  • Carman Research
  • Institute for Behavioral Medicine, LLC
  • Rush University Medical Center
  • Alexian Brothers Center for Psychiatric Research
  • American Medical Research, Inc.
  • Psyichiatric Medicine Associates, LLC
  • Sleep and Behavior Medicine Institute
  • Davis Clinic
  • Pedia Research, LLC
  • Northwest Indiana Center for Clinical Research
  • Clinical Trials Technology, Inc.
  • Heartland Research Associates
  • MCM Clinical Research LLC
  • Pedia Research, LLC
  • Louisiana Clinical Research LLC
  • Pharmasite Research, Inc.
  • Potomac Grove Clinical Research Center
  • Office of Marc Hertzman, MD
  • Adams Clinical Trials, LLC
  • Comprehensive Psyichatric Associates
  • The Center for Pharmaceutical Research PC
  • Private Practice - Howard J. Ilivicky
  • St. Charles Psychiatric Associates - Midwest Research Group
  • Mid-America Clinical Research
  • Mercy Health Research
  • Premier Psychiatric Research Institute
  • Clinical Research Consortium
  • Center For Emotional Fitness
  • Bio Behavioral Health
  • CRI Worldwide, LLC
  • Albuquerque Neuroscience Inc.
  • Montefiore Medical Center
  • Brooklyn Medical Institutes
  • Comprehensive Clinical Development, Inc.
  • Bioscience Research LLC
  • Clinilabs, Inc.
  • Medical & Behavioral Health Research, PC
  • Fieve Clinical Research
  • Mount Sinai School of Medicine
  • Richmond Behavioral Associates
  • Sleep Medicine Centers of Western New York
  • Triangle Neuropsyhiatry
  • Clinical Trials of America
  • Dr. Richard Weisler
  • Northcoast Clinical Trials
  • Community Research, Inc.
  • Ohio State University Department of Psychiatry
  • Midwest Clinical Research Center
  • Lindner Center for Hope
  • North Star Medical Research, LLC
  • Neurology & Neuroscience Center of Ohio
  • IPS Research Company
  • Sooner Clinical Research
  • SP Research, PPC dba Oklahoma Clinical Research Center
  • Summit Research Network (Oregon) Inc.
  • Lehigh Center for Clinical Research
  • Paramount Clinical Research
  • Suburban Research Associates
  • Thomas Jefferson University
  • Belmont Center for Comprehensive Treatment
  • CRI Worldwide LLC
  • UPMC Western Psychiatric Institute and Clinic
  • University Services
  • Rhode Island Mood & Memory Research Institute
  • Medical University of South Carolina, Anxiety Disorders Program
  • Psychiatric Consultants, PC
  • Clinical Neuroscience Solutions, Inc.
  • Research Strategies of Memphis, LLC
  • Clinical Research Associates, Inc.
  • FutureSearch Clinical Trials, LP
  • KRK Medical Research
  • Future Search Trials of Dallas, LP
  • Pillar Clinical Research, LLC
  • Bay Area Clinical Services
  • Houston Clinical Trials, LLC
  • Clinical Trials of Texas, Inc.
  • Wharton Research Center, Inc.
  • Grayline Clinical Drug Trials
  • Ericksen Research and Development
  • Alliance Research Group
  • Summit Research Network (Seattle) LLC
  • Dean Foundation for Health, Research, and Education
  • Independent Physician Consultants (dba IPC Research)
  • Dr. Alexander McIntyre Inc
  • Dr. D. McIntosh & Dr. K. Kjernisted Clinical Research Inc.
  • Chatham-Kent Clinical Trials Research Centre
  • Anxiety and Mood Disorder Center
  • Dr. Sunny Johnson Medical Corporation, Medican Research Associates
  • A. K. Karan Holdings, Ltd.
  • International Sleep Clinic, West Parry Sound Health Centre
  • START Clinic for Mood and Anxiety Disorders
  • Sleep & Alertness Clinic
  • Manna Research
  • Recherches Neuro-Hippocampe
  • l'Hopital Louis H. Lafontaine
  • Kells Medical Research Group Inc.
  • Q & T Research Sherbrooke Inc.
  • Especialidades Medicas L y S
  • Centro de Estudios Clinicos (CEC)
  • Biomedica Research Group
  • Psicomed Estudio Medicos
  • Psychiatrie Ricany
  • Saint Anne s.r.o., Psychiatricka ambulance
  • Psychiatricka ambulance
  • Medicana s.r.o.
  • Supervize s.r.o.
  • Bialbi s.r.o.
  • Clintrial s.r.o.
  • Psychiatry Trial, s.r.o
  • Medical Services Prague s.r.o.
  • Marienthal Psychiatry & Psychology Center of Mustamae
  • North Estonia Medical Centre Foundation
  • Jaanson & Laane Ou
  • Tartu University Hospital
  • ARTES Psykiatrinen Palvelukeskus Oy
  • Satucon Oy / Privater
  • Puutonin Psykiatripalvelu
  • Facharzt fur Neurologie und Psychiatrie
  • Emovis GmbH
  • Complete Facharzt fur Neurologie und Psychiatrie
  • Private Practice Drs. Bitter/Schumann
  • ZSL Zentrum fuer medizinische Studien in Leipzig
  • Complete Karlstr
  • Studienzentrum Klinikum Nuernberg
  • Somni bene GmbH
  • Gemeinschaftspraxis fur Neurologie und Psychiatrie
  • Medizinisches Studienzentrum Wuerzburg
  • Semmelweis Egyetem Pszichiatrial es Pszichoterapias Klinkia
  • Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum
  • B&B Investigaciones Medicas, SC
  • CRI Centro Regiomontano de Investigacion Clinica S.C
  • Prywatne Gabinety Lekarskie "Promedicus" Anna Agnieszka Tomczak
  • Zespol Opleki Zdrowotnej w Chelmole
  • Centrum Badan Klinicznych PI-House sp. z o. o.
  • Centrum Badan Klinicznych Pl-House
  • Klinika Chorob Psychicznych i Zaburzen Nerwicowych Uniwersyteckie Centrum Kliniczne
  • Klinika Chorob Psychicznych i Zaburzen Nerwicowych
  • Centrum Psychiatrii i Psychoterapi
  • NZOZ Syntonia
  • Samodzieiny Publiczny Zespol Zakladow Opieki Zdrowotnej w Zurominie
  • Dharma Institute and Research Center
  • INSPIRA Clinical Research
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia" Sectia Clinica Psihiatrie I
  • Lorentina 2102 SRL
  • Spitalui Clinic Judetean Mures
  • Cape Trial Centre
  • Somerset West Clinical Research Unit
  • Flexivest Fourteen Research Centre
  • Hospital Universitari de Bellvitge
  • Hospital Universitario Infanta Leonor
  • Hospital Fundacion de Alcorcon
  • Centro de Salud Mental II la Corredoria
  • Centro de Salud Alamedilla Unidad de Salud Mental
  • Complejo hospitalario de Zamora
  • Hospital Clinico Universitario Lozano Blesa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SPD489 + Antidepressant

Arm Description

Outcomes

Primary Outcome Measures

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.
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]).
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]).
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]).

Secondary Outcome Measures

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]).
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.
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.
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
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
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
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
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
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
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.
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.
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]).
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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 15, 2011
Last Updated
June 9, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01436175
Brief Title
SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
SPD489 failed to demonstrate a benefit as adjunctive treatment to antidepressants. Termination was not related to any new safety findings.
Study Start Date
February 27, 2012 (Actual)
Primary Completion Date
March 27, 2014 (Actual)
Study Completion Date
March 27, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1570 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPD489 + Antidepressant
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SPD489 (Lisdexamfetamine dimesylate) + Antidepressant
Other Intervention Name(s)
Vyvanse, LDX
Intervention Description
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
Primary Outcome Measure Information:
Title
Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
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.
Time Frame
Week 5 up to Week 52/Early Termination(ET)
Title
Change From Baseline in Systolic Blood Pressure at Week 52
Description
Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).
Time Frame
Baseline, Week 52/ET
Title
Change From Baseline in Diastolic Blood Pressure at Week 52
Description
Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).
Time Frame
Baseline, Week 52/ET
Title
Change From Baseline in Pulse Rate at Week 52
Description
Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).
Time Frame
Baseline, Week 52/ET
Secondary Outcome Measure Information:
Title
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET
Description
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]).
Time Frame
Baseline, Week 52/ET
Title
Number of Participants With Improvement on Clinical Global Impressions - Global Improvement (CGI-I)
Description
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.
Time Frame
Week 52/ET
Title
Short Form-12 Health Survey Version 2 (SF-12V2)
Description
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.
Time Frame
Week 52/ET
Title
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility
Description
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
Time Frame
Week 52/ET
Title
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care
Description
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
Time Frame
Week 52/ET
Title
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities
Description
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
Time Frame
Week 52/ET
Title
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort
Description
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
Time Frame
Week 52/ET
Title
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression
Description
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
Time Frame
Week 52/ET
Title
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Visual Analog Scale
Description
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
Time Frame
Week 52/ET
Title
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
Description
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.
Time Frame
Week 52/ET
Title
Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
Description
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.
Time Frame
Week 52/ET
Title
Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET
Description
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]).
Time Frame
Baseline, Week 52/ET
Title
Amphetamine Cessation Symptom Assessment (ACSA) Total Score
Description
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.
Time Frame
Week 53
Title
Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
Description
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.
Time Frame
Week 52/ET
Title
PRUQ-MDD - Number of Days of Resource Utilization
Description
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.
Time Frame
Week 52/ET
Title
PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)
Description
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.
Time Frame
Week 52/ET
Title
PRUQ-MDD - Number of Hours
Description
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.
Time Frame
Week 52/ET
Title
PRUQ-MDD - Effect of Depressive Symptoms
Description
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.
Time Frame
Week 52/ET

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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