Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
The SPD489-323 Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Inadequate Response to Prospective Treatment With an Antidepressant
2 other identifiers
interventional
1,105
11 countries
101
Brief Summary
This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD) who are taking certain types of antidepressants but continue to have residual depression symptoms. Eligible patients will remain on their antidepressant but will be randomized to either receive supplemental SPD489 or placebo (i.e. sugar pill). The purpose of this study is to help answer the following questions:
- How safe is SPD489 for the supplemental treatment of depression and what are the side effects that might be related to it?
- Can supplemental SPD489 help patients who still have residual depression symptoms while taking an antidepressant?
- How much SPD489 should be given to patients with depression who are also taking an antidepressant?
- How does SPD489 compare to placebo in depressed patients who are also taking an antidepressant?
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 Oct 2011
Typical duration for phase_3 major-depressive-disorder
101 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
October 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2013
CompletedResults Posted
Study results publicly available
November 7, 2014
CompletedJune 9, 2021
May 1, 2021
2.1 years
September 15, 2011
October 31, 2014
May 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 8 Weeks
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
8 weeks
Secondary Outcomes (13)
Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score at 8 Weeks
8 weeks
Percentage of Participants Achieving a 25% Response on the MADRS
Up to 8 weeks
Percentage of Participants Achieving a 50% Response on the MADRS
Up to 8 weeks
Percent of Participants Achieving Remission on the MADRS
Up to 8 weeks
Mean Change From Baseline Over Time in MADRS Total Score
Up to 8 weeks
- +8 more secondary outcomes
Study Arms (2)
Antidepressant + SPD489
EXPERIMENTALAntidepressant + Placebo
PLACEBO COMPARATORInterventions
Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (oral, 20, 30, 50 or 70 mg, once daily) for 8 weeks
Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks
Eligibility Criteria
You may qualify if:
- Subject is able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures.
- Subject is between 18 and 65 years of age.
- Subject has a primary diagnosis of non-psychotic MDD.
- Subject has a MADRS total score \>/=24.
- Subject is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol.
- Subject, who is female, must have a negative serum beta human chorionic gonadotropin (B-HCG) pregnancy test and a negative urine pregnancy test and agrees to comply with any applicable contraceptive requirements of the protocol.
- Subject is able to swallow a capsule.
You may not qualify if:
- Subject whose current episode of MDD has not responded to an adequate treatment regimen with 2 or more approved single antidepressant agents.
- Subject who has a lifetime history of treatment resistant depression, defined as having not responded to adequate treatment with 2 or more treatment regimens.
- Subject has a current co-morbid psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms.
- Subject has been hospitalized (within the last 12 months) for their current MDD episode.
- Subject has a current or lifetime history of attention-deficit/hyperactivity disorder (ADHD).
- Subject has a first degree relative that has been diagnosed with bipolar I disorder.
- Subject has a recent history (within the last 6 months) of suspected substance abuse or dependence disorder.
- Subject is considered a suicide risk, has previously made a suicide attempt within the past 3 years, or is currently demonstrating active suicidal ideation.
- Subject has a concurrent chronic or acute illness or unstable medical condition.
- Subject has a history of seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions.
- Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems.
- Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment within 3 months prior to the Screening Visit.
- Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
- Subject has glaucoma.
- Subject has any clinically significant ECG or clinical laboratory abnormalities.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (101)
ResearchOne, Inc.
Scottsdale, Arizona, 85251, United States
K&S Professional Research Services, LLC
Little Rock, Arkansas, 72201, United States
ATP Clinical Research, Inc.
Costa Mesa, California, 92626, United States
Diligent Clinical Trials
Downey, California, 90241, United States
Synergy Clinical Reserach Center of Escondido
Escondido, California, 92025, United States
Pacific Research Partners, LLC
Oakland, California, 94612, United States
Anderson Clinical Research
Redlands, California, 92374, United States
BreakThrough Clinical Trials, LLC
San Bernardino, California, 92408, United States
MCB Clinical Research Centers
Colorado Springs, Colorado, 80910, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, 34201, United States
Scientific Clinical Research, Inc.
North Miami, Florida, 33161, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, 33716, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Atlanta Institute of Medicine & Research
Atlanta, Georgia, 30328, United States
Pedia Research
Newburgh, Indiana, 47630, United States
Heartland Research Associates
Wichita, Kansas, 67207, United States
Louisiana Clinical Research, LLC
Shreveport, Louisiana, 71115, United States
Comprehensive Psychiatric Associates
Gladstone, Missouri, 64118, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Brooklyn Medical Institute
Brooklyn, New York, 11214, United States
Medical & Behavioral Health Research, PC
New York, New York, 10023, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104, United States
Belmont Center for Comprehensive Treatment
Philadelphia, Pennsylvania, 19131, United States
Medical University South Carolina Anxiety Disorder Program
North Charleston, South Carolina, 29406, United States
Psychiatric Consultants, PC
Franklin, Tennessee, 37067, United States
Research Strategies of Memphis, LLC
Memphis, Tennessee, 38119, United States
KRK Medical Research
Dallas, Texas, 75230, United States
Future Search Trials of Dallas, LP
Dallas, Texas, 75231, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Dr Lieven De Weirdt
Sint-Niklaas, 9100, Belgium
Saint Anne s.r.o.
Brno, 60200, Czechia
Psychiatricka ambulance
Brno, 615 00, Czechia
Medicana s.r.o.
Hořovice, 268 01, Czechia
Psychiatrie s.r.o.
Kutná Hora, 284 01, Czechia
Bialbi s.r.o.
Litoměřice, 41201, Czechia
Clintrial s.r.o.
Prague, 10000, Czechia
Psychiatry Trial s.r.o.
Prague, 15800, Czechia
Prague Medical Services s.r.o.
Prague, 160 00, Czechia
Ricany s.r.o.
Říčany, 251 01, Czechia
Parnu Hospital, Psychiatric Clinic
Pärnu, 80012, Estonia
North Estonia Medical Centre Foundation Psychiatry Clinic
Tallinn, 10614, Estonia
Marienthal Psychiatry and Psychology Center
Tallinn, 10617, Estonia
Jaanson & Laane OU
Tartu, 50406, Estonia
Tartu University Hospital Psychiatric Clinic
Tartu, 50417, Estonia
ARTES Psykiatrinen Palvelukeskus Oy
Helsinki, 00100, Finland
Satucon Oy
Kuopio, 70100, Finland
Satakunnan Psykiatripalveiu Oy at Mentoria Oy
Tampere, 26200, Finland
Puutorin Psykiatripalvelu
Turku, 20100, Finland
Gemeinschafstpraxis für Neurologie und Psychiatrie, Psychotherapie
Achim, 28832, Germany
Private Praxis Dr. Jana Thomsen
Berlin, 10245, Germany
emovis GmbH
Berlin, 10629, Germany
Alexander Schulze, MD
Berlin, 13156, Germany
Private Practice Drs. Bitter/Schumann
Bochum, 44805, Germany
University Hospital Carl Gustav Carus
Dresden, 01307, Germany
ZSL Zentrum fuer medizinische Studien in Leipzig
Leipzig, 04157, Germany
Studienzentrum Muenchen
München, 80333, Germany
Universitaetsklinikum Munster
Münster, 48149, Germany
Studienzentrum Klinikum Nuernberg
Nuremberg, 90419, Germany
Somni bene GmbH
Schwerin, 19053, Germany
Private Practice: Eugen Schlegel
Siegen, 57072, Germany
Studiezentrum Nord-West
Westerstede, 26655, Germany
Medizinisches Studienzentrum Wuerzburg
Würzburg, 97070, Germany
Semmelweis Univ. Dept.of Psychiatry
Budapest, 1083, Hungary
Debrecent Egyetem Orvos es Egeszsegtudomanyl Centrum Pszichiatrai
Debrecen, H-4032, Hungary
Santha Kalman Mentalis Egeszsegkozpont es Szakkorhaz
Nagykálló, 4320, Hungary
Josa Andras Teaching Hospital
Nyíregyháza, H-4400, Hungary
Pecsi Tudomanyegyeiem Pszichiatriai es Pszichoterapias Klinika
Sziget, Hungary
Prywatne Gabinety Lekarskie "Promedicus"
Bialystok, 15-879, Poland
NZOZ Centrum Kultury, Higieny i Zdrowia Psychicznego
Bydgoszcz, 85-156, Poland
Zespol Opieki Zdrowotnej w Chelmnie
Chełmno, 86-200, Poland
Centrum Badan Klinicznuch Pl-House sp. z.o.o.
Gdansk, 80-546, Poland
Klinika Chorob Psychicznych i Zaburzen Nerwicowych
Gdansk, 80-952, Poland
Centrum Psychiatrii i Psychoterapli
Gorlice, 38-300, Poland
NZOZ Syntonia, Poradnia Zdrowia Psychicznego
Kielce, 25-317, Poland
Osrodek Badafi Klinicznych Prof dr hab n med Meszek Szczepanski Prywatna Praktyka Lekarska
Lublin, 20-022, Poland
Samodzielny Publiczny Zespol Zakladow Opieki Zdrowotnej w Zurominie
Żuromin, 09-300, Poland
Spitatul Clinic Judetean de Urgenta Arad, Clinica de Psihiatrie
Arad, 310022, Romania
Stefi-Dent SRL
Botoșani, 710107, Romania
Spitalui Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia" Sectia Clinica Psihiatrie I
Bucharest, 041915, Romania
Crucea Alba
Oradea, 410163, Romania
Lorentina 2201 SRL
Târgovişte, 130081, Romania
Spitalul Clinic Judetean Mures
Târgu Mureş, 540095, Romania
Cape Trial Centre
Bellville, Cape Town, 7530, South Africa
Flexivest Fourteen Research Centre
Bellville, Cape Town, 7530, South Africa
Private Practice - Gerta Brink
Johannesburg, Gauten, 2195, South Africa
Somerset West Clinical Research
Somerset West, Western Cape, South Africa
Vista Clinic
Centurion, 0046, South Africa
George Medi Clinic Extension
George, 6529, South Africa
SU/ Affektiva 1
Gothenburg, 41685, Sweden
ProbarE i Lund AB
Lund, 22222, Sweden
Ekdahl Medical AB
Malmo, 21153, Sweden
INM Psykiatrisk Mottagning
Malmo, 21153, Sweden
Medinstructor Lippitz AB
Stockholm, 11486, Sweden
Dr. Wahlstedts mottagning
Uppsala, 75310, Sweden
Related Publications (1)
Richards C, McIntyre RS, Weisler R, Sambunaris A, Brawman-Mintzer O, Gao J, Geibel B, Dauphin M, Madhoo M. Lisdexamfetamine dimesylate augmentation for adults with major depressive disorder and inadequate response to antidepressant monotherapy: Results from 2 phase 3, multicenter, randomized, double-blind, placebo-controlled studies. J Affect Disord. 2016 Dec;206:151-160. doi: 10.1016/j.jad.2016.07.006. Epub 2016 Jul 5.
PMID: 27474961RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2011
First Posted
September 19, 2011
Study Start
October 19, 2011
Primary Completion
December 10, 2013
Study Completion
December 10, 2013
Last Updated
June 9, 2021
Results First Posted
November 7, 2014
Record last verified: 2021-05