Study Stopped
SPD489 failed to demonstrate a benefit as adjunctive treatment to antidepressants. Termination was not related to any new safety findings.
SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study
A Phase 3, Open-label, Multicenter, 12-month Extension Safety and Tolerability Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Residual Symptoms or Inadequate Response Following Treatment With an Antidepressant
2 other identifiers
interventional
1,570
13 countries
208
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 major-depressive-disorder
Started Feb 2012
Typical duration for phase_3 major-depressive-disorder
208 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2011
CompletedFirst Posted
Study publicly available on registry
September 19, 2011
CompletedStudy Start
First participant enrolled
February 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2014
CompletedResults Posted
Study results publicly available
February 23, 2015
CompletedJune 14, 2021
June 1, 2021
2.1 years
September 15, 2011
February 5, 2015
June 9, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviour during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.
Week 5 up to Week 52/Early Termination(ET)
Change From Baseline in Systolic Blood Pressure at Week 52
Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
Baseline, Week 52/ET
Change From Baseline in Diastolic Blood Pressure at Week 52
Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
Baseline, Week 52/ET
Change From Baseline in Pulse Rate at Week 52
Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
Baseline, Week 52/ET
Secondary Outcomes (18)
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET
Baseline, Week 52/ET
Number of Participants With Improvement on Clinical Global Impressions - Global Improvement (CGI-I)
Week 52/ET
Short Form-12 Health Survey Version 2 (SF-12V2)
Week 52/ET
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility
Week 52/ET
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care
Week 52/ET
- +13 more secondary outcomes
Study Arms (1)
SPD489 + Antidepressant
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (212)
Birmingham Research Group
Birmingham, Alabama, 35216, United States
ResearchOne, Inc.
Scottsdale, Arizona, 85251, United States
Arkansas Psychiatric Clinical Research Trials, P.A.
Little Rock, Arkansas, 72223, United States
South Coast Clinical Trials, Inc.
Anaheim, California, 92804, United States
American Neuropsychiatric Research, Inc.
Carson, California, 90746, United States
Catalina Research Institute, LLC
Chino, California, 91710, United States
Shanti Clinical Trials
Colton, California, 92324, United States
ATP Clinical Research
Costa Mesa, California, 92626, United States
Clinical Innovation, Inc.
Costa Mesa, California, 92626, United States
Diligent Clinical Trials
Downey, California, 90241, United States
Synergy Clinical Research Center of Escondido
Escondido, California, 92025, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845, United States
UC, Irvine Child Development Center
Irvine, California, 92612, United States
Irvine Center For Clinical Research
Irvine, California, 92618, United States
Omega Clinical Trials, LLC
La Habra, California, 90631, United States
Semel Institute for Neuroscience & Human Behavior at UCLA
Los Angeles, California, 90024, United States
Pacific Research Partners
Oakland, California, 94612, United States
North County Clinical Research
Oceanside, California, 92066, United States
Pasadena Research Institute, LLC
Pasadena, California, 91106, United States
Anderson Clinical Research
Redlands, California, 92374, United States
BreakThrough Clinical Trials, LLC
San Bernardino, California, 92408, United States
Affiliated Research Institute
San Diego, California, 92108, United States
PCSD - Feighner Research
San Diego, California, 92108, United States
Clinical Innovations, Inc.
San Diego, California, 92121, United States
Sharp Mesa Vista Hospital
San Diego, California, 92123', United States
Artemis Institute for Clinical Research
San Diego, California, 92123, United States
Neuropsychiatric Center of Orange County
Santa Ana, California, 92701, United States
Caliifornia Neuroscience Research Medical Group
Sherman Oaks, California, 91403, United States
MCB Clinical Research Centers
Colorado Springs, Colorado, 80910, United States
Western Affiliated Research Institute
Denver, Colorado, 80209, United States
Connecticut Clinical Research
Cromwell, Connecticut, 06416, United States
Geriatric and Adult Psychiatry, LLC
Hamden, Connecticut, 06518, United States
Institute of Living - Hartford Hospital
Hartford, Connecticut, 06106, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, 34201, United States
CNS Clinical Research Group
Coral Springs, Florida, 33067, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912, United States
Emerald Coast Mood & Memory, PA
Fort Walton Beach, Florida, 32547, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216, United States
Amit Vijapura MD
Jacksonville, Florida, 32256, United States
Psychiatric Associates
Lake City, Florida, 32025, United States
Florida Clinical Research Center, LLC
Maitland, Florida, 32751, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
Fidelity Clinical Research Inc
North Miami, Florida, 33161, United States
Scientific Clinical Research Inc.
North Miami, Florida, 33161, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Ali A. Kashfi, MD, PA
Orlando, Florida, 32889, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Comprehensive Clinical Development, Inc.
St. Petersburg, Florida, 33716, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407, United States
Clinical Research of Central Florida
Winter Haven, Florida, 33880, United States
Kolin Research Group
Winter Park, Florida, 32789, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Atlanta Institute of Medicine & Research
Atlanta, Georgia, 30328, United States
Carman Research
Smyrna, Georgia, 30080, United States
Institute for Behavioral Medicine, LLC
Smyrna, Georgia, 30080, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169, United States
American Medical Research, Inc.
Oakbrook Terrace, Illinois, 60523, United States
Psyichiatric Medicine Associates, LLC
Skokie, Illinois, 60076, United States
Sleep and Behavior Medicine Institute
Vernon Hills, Illinois, 60061, United States
Davis Clinic
Indianapolis, Indiana, 46250, United States
Pedia Research, LLC
Newburgh, Indiana, 47630, United States
Northwest Indiana Center for Clinical Research
Valparaiso, Indiana, 46383, United States
Clinical Trials Technology, Inc.
Prairie Village, Kansas, 66206, United States
Heartland Research Associates
Wichita, Kansas, 67207, United States
MCM Clinical Research LLC
Florence, Kentucky, 41042, United States
Pedia Research, LLC
Owensboro, Kentucky, 42301, United States
Louisiana Clinical Research LLC
Shreveport, Louisiana, 71101, United States
Pharmasite Research, Inc.
Baltimore, Maryland, 21208, United States
Potomac Grove Clinical Research Center
Gaithersburg, Maryland, 20877, United States
Office of Marc Hertzman, MD
Rockville, Maryland, 20852, United States
Adams Clinical Trials, LLC
Watertown, Massachusetts, 02472, United States
Comprehensive Psyichatric Associates
Gladstone, Missouri, 64118, United States
The Center for Pharmaceutical Research PC
Kansas City, Missouri, 64114, United States
Private Practice - Howard J. Ilivicky
O'Fallon, Missouri, 63368, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63301, United States
Mid-America Clinical Research
St Louis, Missouri, 63109, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Premier Psychiatric Research Institute
Lincoln, Nebraska, 68526, United States
Clinical Research Consortium
Las Vegas, Nevada, 89119, United States
Center For Emotional Fitness
Cherry Hill, New Jersey, 08002, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
CRI Worldwide, LLC
Willingboro, New Jersey, 08046, United States
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, 87109, United States
Brooklyn Medical Institutes
Brooklyn, New York, 11214, United States
Comprehensive Clinical Development, Inc.
Fresh Meadows, New York, 11366, United States
Bioscience Research LLC
Mount Kisco, New York, 10549, United States
Clinilabs, Inc.
New York, New York, 10019, United States
Medical & Behavioral Health Research, PC
New York, New York, 10023, United States
Fieve Clinical Research
New York, New York, 10075, United States
Mount Sinai School of Medicine
New York, New York, 11029, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Sleep Medicine Centers of Western New York
West Seneca, New York, 14224, United States
Triangle Neuropsyhiatry
Durham, North Carolina, 27707, United States
Clinical Trials of America
Hickory, North Carolina, 28601, United States
Dr. Richard Weisler
Raleigh, North Carolina, 27609, United States
Northcoast Clinical Trials
Beachwood, Ohio, 44122, United States
Community Research, Inc.
Cincinnati, Ohio, 45227, United States
Ohio State University Department of Psychiatry
Columbus, Ohio, 43210, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
Lindner Center for Hope
Mason, Ohio, 45040, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130, United States
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, 43623, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112, United States
SP Research, PPC dba Oklahoma Clinical Research Center
Oklahoma City, Oklahoma, 73112, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, 97210, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104, United States
Paramount Clinical Research
Bridgeville, Pennsylvania, 15017, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Belmont Center for Comprehensive Treatment
Philadelphia, Pennsylvania, 19131, United States
CRI Worldwide LLC
Philadelphia, Pennsylvania, 19139, United States
UPMC Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213, United States
University Services
West Chester, Pennsylvania, 19380, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02914, United States
Medical University of South Carolina, Anxiety Disorders Program
North Charleston, South Carolina, 29406, United States
Psychiatric Consultants, PC
Franklin, Tennessee, 37067, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Research Strategies of Memphis, LLC
Memphis, Tennessee, 38119, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203, United States
FutureSearch Clinical Trials, LP
Austin, Texas, 78731, United States
KRK Medical Research
Dallas, Texas, 75230, United States
Future Search Trials of Dallas, LP
Dallas, Texas, 75231, United States
Pillar Clinical Research, LLC
Dallas, Texas, 75243, United States
Bay Area Clinical Services
Friendswood, Texas, 77546, United States
Houston Clinical Trials, LLC
Houston, Texas, 77098, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Wharton Research Center, Inc.
Wharton, Texas, 77488, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
Ericksen Research and Development
Clinton, Utah, 84015, United States
Alliance Research Group
Richmond, Virginia, 23236, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, 98125, United States
Dean Foundation for Health, Research, and Education
Middleton, Wisconsin, 53562, United States
Independent Physician Consultants (dba IPC Research)
Waukesha, Wisconsin, 53188, United States
Dr. Alexander McIntyre Inc
Penticton, British Columbia, V2A 4M4, Canada
Dr. D. McIntosh & Dr. K. Kjernisted Clinical Research Inc.
Vancouver, British Columbia, V6Z 2L4, Canada
Chatham-Kent Clinical Trials Research Centre
Chatham, Ontario, N7M 5L9, Canada
Anxiety and Mood Disorder Center
Mississauga, Ontario, L5M 4N4, Canada
Dr. Sunny Johnson Medical Corporation, Medican Research Associates
Mississauga, Ontario, L5M 4N4, Canada
A. K. Karan Holdings, Ltd.
Oakville, Ontario, L6J 0B2, Canada
International Sleep Clinic, West Parry Sound Health Centre
Parry Sound, Ontario, P2A 3A4, Canada
START Clinic for Mood and Anxiety Disorders
Toronto, Ontario, M4W2N4, Canada
Sleep & Alertness Clinic
Toronto, Ontario, M6J 3S3, Canada
Manna Research
Toronto, Ontario, M9W 4L6, Canada
Recherches Neuro-Hippocampe
Gatineau, Quebec, J9A 1K7, Canada
l'Hopital Louis H. Lafontaine
Montreal, Quebec, H1N 3M5, Canada
Kells Medical Research Group Inc.
Pointe-Claire, Quebec, H9R 4S3, Canada
Q & T Research Sherbrooke Inc.
Sherbrooke, Quebec, J1H 4J6, Canada
Especialidades Medicas L y S
Las Condes, Santiagio, 7560356, Chile
Centro de Estudios Clinicos (CEC)
Providencia, Santiago Metropolitan, 7510186, Chile
Biomedica Research Group
Providencia, Santiego, 7500710, Chile
Psicomed Estudio Medicos
Antofagasta, 1270244, Chile
Psychiatrie Ricany
Říčany, Praha Vychod, 251 01, Czechia
Saint Anne s.r.o., Psychiatricka ambulance
Brno, 602 00, Czechia
Psychiatricka ambulance
Brno, 615 00, Czechia
Medicana s.r.o.
Hořovice, 268 01, Czechia
Supervize s.r.o.
Kutná Hora, 284 01, Czechia
Bialbi s.r.o.
Litoměřice, 41201, Czechia
Clintrial s.r.o.
Prague, 120 00, Czechia
Psychiatry Trial, s.r.o
Prague, 15800, Czechia
Medical Services Prague s.r.o.
Prague, 160 00, Czechia
Marienthal Psychiatry & Psychology Center of Mustamae
Tallinn, 10617, Estonia
North Estonia Medical Centre Foundation
Tallinn, Estonia
Jaanson & Laane Ou
Tartu, 50406, Estonia
Tartu University Hospital
Tartu, 50417, Estonia
ARTES Psykiatrinen Palvelukeskus Oy
Helsinki, 00100, Finland
Satucon Oy / Privater
Kuopio, 70100, Finland
Puutonin Psykiatripalvelu
Turku, 20100, Finland
Facharzt fur Neurologie und Psychiatrie
Berlin, 10245, Germany
Emovis GmbH
Berlin, 10629, Germany
Complete Facharzt fur Neurologie und Psychiatrie
Berlin, 13156, Germany
Private Practice Drs. Bitter/Schumann
Bochum, 44805, Germany
ZSL Zentrum fuer medizinische Studien in Leipzig
Leipzig, 04157, Germany
Complete Karlstr
München, 80333, Germany
Studienzentrum Klinikum Nuernberg
Nuremberg, 90419, Germany
Somni bene GmbH
Schwerin, 19053, Germany
Gemeinschaftspraxis fur Neurologie und Psychiatrie
Westerstede, 26655, Germany
Medizinisches Studienzentrum Wuerzburg
Würzburg, 97070, Germany
Semmelweis Egyetem Pszichiatrial es Pszichoterapias Klinkia
Budapest, Hungary
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum
Debrecen, Hungary
B&B Investigaciones Medicas, SC
Sinaloa, Mazatian, 82126, Mexico
CRI Centro Regiomontano de Investigacion Clinica S.C
Nuevo León, Monterrey, 64710, Mexico
Prywatne Gabinety Lekarskie "Promedicus" Anna Agnieszka Tomczak
Bialystok, 15-879, Poland
Zespol Opleki Zdrowotnej w Chelmole
Chełmno, 86-200, Poland
Centrum Badan Klinicznych PI-House sp. z o. o.
Gdansk, 80-546, Poland
Centrum Badan Klinicznych Pl-House
Gdansk, 80-546, Poland
Klinika Chorob Psychicznych i Zaburzen Nerwicowych Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
Klinika Chorob Psychicznych i Zaburzen Nerwicowych
Gdansk, Poland
Centrum Psychiatrii i Psychoterapi
Gorlice, 38-300, Poland
NZOZ Syntonia
Kielce, 25-317, Poland
Samodzieiny Publiczny Zespol Zakladow Opieki Zdrowotnej w Zurominie
Żuromin, 09-300, Poland
Dharma Institute and Research Center
San Juan, 00907, Puerto Rico
INSPIRA Clinical Research
San Juan, 00918, Puerto Rico
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia" Sectia Clinica Psihiatrie I
Bucharest, 041915', Romania
Lorentina 2102 SRL
Târgovişte, 130081, Romania
Spitalui Clinic Judetean Mures
Târgu Mureş, 540096, Romania
Cape Trial Centre
Bellville, Cape Town, 7530, South Africa
Somerset West Clinical Research Unit
Somerset West, Western Cape, South Africa
Flexivest Fourteen Research Centre
Cape Town, South Africa
Hospital Universitari de Bellvitge
Barcelona, 08907, Spain
Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
Hospital Fundacion de Alcorcon
Madrid, 28922, Spain
Centro de Salud Mental II la Corredoria
Oviedo, 33011, Spain
Centro de Salud Alamedilla Unidad de Salud Mental
Salamanca, 37003, Spain
Complejo hospitalario de Zamora
Zamora, 49021, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated on 11 Feb 2014. SPD489 failed to demonstrate a benefit as adjunctive treatment to antidepressants. Termination was not related to any new safety findings.
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2011
First Posted
September 19, 2011
Study Start
February 27, 2012
Primary Completion
March 27, 2014
Study Completion
March 27, 2014
Last Updated
June 14, 2021
Results First Posted
February 23, 2015
Record last verified: 2021-06