Clinical trial NCT01436175: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-09-19
Enrollment: 1570
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Week 5 up to Week 52/Early Termination(ET)
measure: Change From Baseline in Systolic Blood Pressure at Week 52
timeFrame: Baseline, Week 52/ET
measure: Change From Baseline in Diastolic Blood Pressure at Week 52
timeFrame: Baseline, Week 52/ET
measure: Change From Baseline in Pulse Rate at Week 52
timeFrame: Baseline, Week 52/ET
Secondary outcomes:
measure: Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET
timeFrame: Baseline, Week 52/ET
measure: Number of Participants With Improvement on Clinical Global Impressions - Global Improvement (CGI-I)
timeFrame: Week 52/ET
measure: Short Form-12 Health Survey Version 2 (SF-12V2)
timeFrame: Week 52/ET
measure: EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility
timeFrame: Week 52/ET
measure: EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care
timeFrame: Week 52/ET
measure: EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities
timeFrame: Week 52/ET
measure: EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort
timeFrame: Week 52/ET
measure: EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression
timeFrame: Week 52/ET
measure: EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Visual Analog Scale
timeFrame: Week 52/ET
measure: Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
timeFrame: Week 52/ET
measure: Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
timeFrame: Week 52/ET
measure: Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET
timeFrame: Baseline, Week 52/ET
measure: Amphetamine Cessation Symptom Assessment (ACSA) Total Score
timeFrame: Week 53
measure: Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
timeFrame: Week 52/ET
measure: PRUQ-MDD - Number of Days of Resource Utilization
timeFrame: Week 52/ET
measure: PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)
timeFrame: Week 52/ET
measure: PRUQ-MDD - Number of Hours
timeFrame: Week 52/ET
measure: PRUQ-MDD - Effect of Depressive Symptoms
timeFrame: Week 52/ET
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Research Group
state: Alabama
city: Scottsdale
country: United States
facility: ResearchOne, Inc.
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Psychiatric Clinical Research Trials, P.A.
state: Arkansas
city: Anaheim
country: United States
facility: South Coast Clinical Trials, Inc.
state: California
city: Carson
country: United States
facility: American Neuropsychiatric Research, Inc.
state: California
city: Chino
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Colton
country: United States
facility: Shanti Clinical Trials
state: California
city: Costa Mesa
country: United States
facility: ATP Clinical Research
state: California
city: Costa Mesa
country: United States
facility: Clinical Innovation, Inc.
state: California
city: Downey
country: United States
facility: Diligent Clinical Trials
state: California
city: Escondido
country: United States
facility: Synergy Clinical Research Center of Escondido
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: Irvine
country: United States
facility: UC, Irvine Child Development Center
state: California
city: Irvine
country: United States
facility: Irvine Center For Clinical Research
state: California
city: La Habra
country: United States
facility: Omega Clinical Trials, LLC
state: California
city: Los Angeles
country: United States
facility: Semel Institute for Neuroscience & Human Behavior at UCLA
state: California
city: Oakland
country: United States
facility: Pacific Research Partners
state: California
city: Oceanside
country: United States
facility: North County Clinical Research
state: California
city: Pasadena
country: United States
facility: Pasadena Research Institute, LLC
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: San Bernardino
country: United States
facility: BreakThrough Clinical Trials, LLC
state: California
city: San Diego
country: United States
facility: Affiliated Research Institute
state: California
city: San Diego
country: United States
facility: PCSD - Feighner Research
state: California
city: San Diego
country: United States
facility: Clinical Innovations, Inc.
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Santa Ana
country: United States
facility: Neuropsychiatric Center of Orange County
state: California
city: Sherman Oaks
country: United States
facility: Caliifornia Neuroscience Research Medical Group
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers
state: Colorado
city: Denver
country: United States
facility: Western Affiliated Research Institute
state: Colorado
city: Cromwell
country: United States
facility: Connecticut Clinical Research
state: Connecticut
city: Hamden
country: United States
facility: Geriatric and Adult Psychiatry, LLC
state: Connecticut
city: Hartford
country: United States
facility: Institute of Living - Hartford Hospital
state: Connecticut
city: New Britain
country: United States
facility: The Hospital of Central Connecticut
state: Connecticut
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Coral Springs
country: United States
facility: CNS Clinical Research Group
state: Florida
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
state: Florida
city: Fort Walton Beach
country: United States
facility: Emerald Coast Mood & Memory, PA
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Amit Vijapura MD
state: Florida
city: Lake City
country: United States
facility: Psychiatric Associates
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: North Miami
country: United States
facility: Fidelity Clinical Research Inc
state: Florida
city: North Miami
country: United States
facility: Scientific Clinical Research Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Orlando
country: United States
facility: Ali A. Kashfi, MD, PA
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Saint Petersburg
country: United States
facility: Comprehensive Clinical Development, Inc.
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center for Psychiatric Research
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Central Florida
state: Florida
city: Winter Park
country: United States
facility: Kolin Research Group
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Institute of Medicine & Research
state: Georgia
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Smyrna
country: United States
facility: Institute for Behavioral Medicine, LLC
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Hoffman Estates
country: United States
facility: Alexian Brothers Center for Psychiatric Research
state: Illinois
city: Oakbrook Terrace
country: United States
facility: American Medical Research, Inc.
state: Illinois
city: Skokie
country: United States
facility: Psyichiatric Medicine Associates, LLC
state: Illinois
city: Vernon Hills
country: United States
facility: Sleep and Behavior Medicine Institute
state: Illinois
city: Indianapolis
country: United States
facility: Davis Clinic
state: Indiana
city: Newburgh
country: United States
facility: Pedia Research, LLC
state: Indiana
city: Valparaiso
country: United States
facility: Northwest Indiana Center for Clinical Research
state: Indiana
city: Prairie Village
country: United States
facility: Clinical Trials Technology, Inc.
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates
state: Kansas
city: Florence
country: United States
facility: MCM Clinical Research LLC
state: Kentucky
city: Owensboro
country: United States
facility: Pedia Research, LLC
state: Kentucky
city: Shreveport
country: United States
facility: Louisiana Clinical Research LLC
state: Louisiana
city: Baltimore
country: United States
facility: Pharmasite Research, Inc.
state: Maryland
city: Gaithersburg
country: United States
facility: Potomac Grove Clinical Research Center
state: Maryland
city: Rockville
country: United States
facility: Office of Marc Hertzman, MD
state: Maryland
city: Watertown
country: United States
facility: Adams Clinical Trials, LLC
state: Massachusetts
city: Gladstone
country: United States
facility: Comprehensive Psyichatric Associates
state: Missouri
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research PC
state: Missouri
city: O'Fallon
country: United States
facility: Private Practice - Howard J. Ilivicky
state: Missouri
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates - Midwest Research Group
state: Missouri
city: Saint Louis
country: United States
facility: Mid-America Clinical Research
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Lincoln
country: United States
facility: Premier Psychiatric Research Institute
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Consortium
state: Nevada
city: Cherry Hill
country: United States
facility: Center For Emotional Fitness
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Willingboro
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience Inc.
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: Brooklyn Medical Institutes
state: New York
city: Fresh Meadows
country: United States
facility: Comprehensive Clinical Development, Inc.
state: New York
city: Mount Kisco
country: United States
facility: Bioscience Research LLC
state: New York
city: New York
country: United States
facility: Clinilabs, Inc.
state: New York
city: New York
country: United States
facility: Medical & Behavioral Health Research, PC
state: New York
city: New York
country: United States
facility: Fieve Clinical Research
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: West Seneca
country: United States
facility: Sleep Medicine Centers of Western New York
state: New York
city: Durham
country: United States
facility: Triangle Neuropsyhiatry
state: North Carolina
city: Hickory
country: United States
facility: Clinical Trials of America
state: North Carolina
city: Raleigh
country: United States
facility: Dr. Richard Weisler
state: North Carolina
city: Beachwood
country: United States
facility: Northcoast Clinical Trials
state: Ohio
city: Cincinnati
country: United States
facility: Community Research, Inc.
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Department of Psychiatry
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Mason
country: United States
facility: Lindner Center for Hope
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research, LLC
state: Ohio
city: Toledo
country: United States
facility: Neurology & Neuroscience Center of Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: SP Research, PPC dba Oklahoma Clinical Research Center
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network (Oregon) Inc.
state: Oregon
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Bridgeville
country: United States
facility: Paramount Clinical Research
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Belmont Center for Comprehensive Treatment
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Worldwide LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Western Psychiatric Institute and Clinic
state: Pennsylvania
city: West Chester
country: United States
facility: University Services
state: Pennsylvania
city: East Providence
country: United States
facility: Rhode Island Mood & Memory Research Institute
state: Rhode Island
city: North Charleston
country: United States
facility: Medical University of South Carolina, Anxiety Disorders Program
state: South Carolina
city: Franklin
country: United States
facility: Psychiatric Consultants, PC
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Memphis
country: United States
facility: Research Strategies of Memphis, LLC
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Clinical Trials, LP
state: Texas
city: Dallas
country: United States
facility: KRK Medical Research
state: Texas
city: Dallas
country: United States
facility: Future Search Trials of Dallas, LP
state: Texas
city: Dallas
country: United States
facility: Pillar Clinical Research, LLC
state: Texas
city: Friendswood
country: United States
facility: Bay Area Clinical Services
state: Texas
city: Houston
country: United States
facility: Houston Clinical Trials, LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Wharton
country: United States
facility: Wharton Research Center, Inc.
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Clinton
country: United States
facility: Ericksen Research and Development
state: Utah
city: Richmond
country: United States
facility: Alliance Research Group
state: Virginia
city: Seattle
country: United States
facility: Summit Research Network (Seattle) LLC
state: Washington
city: Middleton
country: United States
facility: Dean Foundation for Health, Research, and Education
state: Wisconsin
city: Waukesha
country: United States
facility: Independent Physician Consultants (dba IPC Research)
state: Wisconsin
city: Penticton
country: Canada
facility: Dr. Alexander McIntyre Inc
state: British Columbia
city: Vancouver
country: Canada
facility: Dr. D. McIntosh & Dr. K. Kjernisted Clinical Research Inc.
state: British Columbia
city: Chatham
country: Canada
facility: Chatham-Kent Clinical Trials Research Centre
state: Ontario
city: Mississauga
country: Canada
facility: Anxiety and Mood Disorder Center
state: Ontario
city: Mississauga
country: Canada
facility: Dr. Sunny Johnson Medical Corporation, Medican Research Associates
state: Ontario
city: Oakville
country: Canada
facility: A. K. Karan Holdings, Ltd.
state: Ontario
city: Parry Sound
country: Canada
facility: International Sleep Clinic, West Parry Sound Health Centre
state: Ontario
city: Toronto
country: Canada
facility: START Clinic for Mood and Anxiety Disorders
state: Ontario
city: Toronto
country: Canada
facility: Sleep & Alertness Clinic
state: Ontario
city: Toronto
country: Canada
facility: Manna Research
state: Ontario
city: Gatineau
country: Canada
facility: Recherches Neuro-Hippocampe
state: Quebec
city: Montreal
country: Canada
facility: l'Hopital Louis H. Lafontaine
state: Quebec
city: Pointe Claire
country: Canada
facility: Kells Medical Research Group Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: Q & T Research Sherbrooke Inc.
state: Quebec
city: Las Condes
country: Chile
facility: Especialidades Medicas L y S
state: Santiagio
city: Providencia
country: Chile
facility: Centro de Estudios Clinicos (CEC)
state: Santiago
city: Providencia
country: Chile
facility: Biomedica Research Group
state: Santiego
city: Antofagasta
country: Chile
facility: Psicomed Estudio Medicos
city: Ricany
country: Czechia
facility: Psychiatrie Ricany
state: Praha Vychod
city: Brno
country: Czechia
facility: Saint Anne s.r.o., Psychiatricka ambulance
city: Brno
country: Czechia
facility: Psychiatricka ambulance
city: Horovice
country: Czechia
facility: Medicana s.r.o.
city: Kutna Hora
country: Czechia
facility: Supervize s.r.o.
city: Litomerice
country: Czechia
facility: Bialbi s.r.o.
city: Prague 10
country: Czechia
facility: Clintrial s.r.o.
city: Prague
country: Czechia
facility: Psychiatry Trial, s.r.o
city: Prague
country: Czechia
facility: Medical Services Prague s.r.o.
city: Tallinn
country: Estonia
facility: Marienthal Psychiatry & Psychology Center of Mustamae
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Tartu
country: Estonia
facility: Jaanson & Laane Ou
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Helsinki
country: Finland
facility: ARTES Psykiatrinen Palvelukeskus Oy
city: Kuopio
country: Finland
facility: Satucon Oy / Privater
city: Turku
country: Finland
facility: Puutonin Psykiatripalvelu
city: Berlin
country: Germany
facility: Facharzt fur Neurologie und Psychiatrie
city: Berlin
country: Germany
facility: Emovis GmbH
city: Berlin
country: Germany
facility: Complete Facharzt fur Neurologie und Psychiatrie
city: Bochum
country: Germany
facility: Private Practice Drs. Bitter/Schumann
city: Leipzig
country: Germany
facility: ZSL Zentrum fuer medizinische Studien in Leipzig
city: Munchen
country: Germany
facility: Complete Karlstr
city: Nuernberg
country: Germany
facility: Studienzentrum Klinikum Nuernberg
city: Schwerin
country: Germany
facility: Somni bene GmbH
city: Westerstede
country: Germany
facility: Gemeinschaftspraxis fur Neurologie und Psychiatrie
city: Wuerzburg
country: Germany
facility: Medizinisches Studienzentrum Wuerzburg
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Pszichiatrial es Pszichoterapias Klinkia
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum
city: Sinaloa
country: Mexico
facility: B&B Investigaciones Medicas, SC
state: Mazatian
city: Nuevo Leon
country: Mexico
facility: CRI Centro Regiomontano de Investigacion Clinica S.C
state: Monterrey
city: Bialystok
country: Poland
facility: Prywatne Gabinety Lekarskie "Promedicus" Anna Agnieszka Tomczak
city: Chelmno
country: Poland
facility: Zespol Opleki Zdrowotnej w Chelmole
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o. o.
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych Pl-House
city: Gdansk
country: Poland
facility: Klinika Chorob Psychicznych i Zaburzen Nerwicowych Uniwersyteckie Centrum Kliniczne
city: Gdansk
country: Poland
facility: Klinika Chorob Psychicznych i Zaburzen Nerwicowych
city: Gorlice
country: Poland
facility: Centrum Psychiatrii i Psychoterapi
city: Kielce
country: Poland
facility: NZOZ Syntonia
city: Zuromin
country: Poland
facility: Samodzieiny Publiczny Zespol Zakladow Opieki Zdrowotnej w Zurominie
city: San Juan
country: Puerto Rico
facility: Dharma Institute and Research Center
city: San Juan
country: Puerto Rico
facility: INSPIRA Clinical Research
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia" Sectia Clinica Psihiatrie I
city: Targoviste
country: Romania
facility: Lorentina 2102 SRL
city: Targu Mures
country: Romania
facility: Spitalui Clinic Judetean Mures
city: Bellville
country: South Africa
facility: Cape Trial Centre
state: Cape Town
city: Somerset West
country: South Africa
facility: Somerset West Clinical Research Unit
state: Western Cape
city: Cape Town
country: South Africa
facility: Flexivest Fourteen Research Centre
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Fundacion de Alcorcon
city: Oviedo
country: Spain
facility: Centro de Salud Mental II la Corredoria
city: Salamanca
country: Spain
facility: Centro de Salud Alamedilla Unidad de Salud Mental
city: Zamora
country: Spain
facility: Complejo hospitalario de Zamora
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: