Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
NCT ID: NCT01436162
Last Updated: 2021-06-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1105 participants
INTERVENTIONAL
2011-10-19
2013-12-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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?
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
NCT01436149
SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
NCT01435759
SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study
NCT01436175
SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder
NCT00985725
Adjunctive Mixed Salts Amphetamine for Depressed Adults With Incomplete Response to Current Antidepressant Therapy
NCT02058693
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Antidepressant + SPD489
Antidepressant + SPD489 (Lisdexamfetamine dimesylate )
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 + Placebo
Antidepressant + Placebo
Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Antidepressant + SPD489 (Lisdexamfetamine dimesylate )
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 + Placebo
Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subject is between 18 and 65 years of age.
3. Subject has a primary diagnosis of non-psychotic MDD.
4. Subject has a MADRS total score \>/=24.
5. Subject is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol.
6. 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.
7. Subject is able to swallow a capsule.
Exclusion Criteria
2. Subject who has a lifetime history of treatment resistant depression, defined as having not responded to adequate treatment with 2 or more treatment regimens.
3. 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.
4. Subject has been hospitalized (within the last 12 months) for their current MDD episode.
5. Subject has a current or lifetime history of attention-deficit/hyperactivity disorder (ADHD).
6. Subject has a first degree relative that has been diagnosed with bipolar I disorder.
7. Subject has a recent history (within the last 6 months) of suspected substance abuse or dependence disorder.
8. Subject is considered a suicide risk, has previously made a suicide attempt within the past 3 years, or is currently demonstrating active suicidal ideation.
9. Subject has a concurrent chronic or acute illness or unstable medical condition.
10. 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.
11. 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.
12. 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.
13. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
14. Subject has glaucoma.
15. Subject has any clinically significant ECG or clinical laboratory abnormalities.
16. Subject has a history of moderate to severe hypertension.
17. Current use of any other medications (including over-the-counter \[OTC\], herbal or homeopathic preparations) that have central nervous system effects.
18. Subject has the potential need to initiate or modify frequency of psychotherapy or to continue or initiate other treatments for depression, outside of those allowed in this protocol.
19. Subject has had electroconvulsive therapy (ECT) for the current depressive episode 3 months prior to the Lead-in Baseline Visit.
20. The subject has a known or suspected intolerance or hypersensitivity to the investigational product.
21. The subject has a known or suspected intolerance, hypersensitivity, or contraindications to their assigned antidepressant treatments (escitalopram oxalate, sertraline HCl, venlafaxine HCl extended release, or duloxetine HCl).
22. Subject has a positive urine drug result.
23. Subject has a body mass index (BMI) of \<18.5 or \>40.
24. Subject is female and is pregnant or nursing.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shire
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ResearchOne, Inc.
Scottsdale, Arizona, United States
K&S Professional Research Services, LLC
Little Rock, Arkansas, United States
ATP Clinical Research, Inc.
Costa Mesa, California, United States
Diligent Clinical Trials
Downey, California, United States
Synergy Clinical Reserach Center of Escondido
Escondido, California, United States
Pacific Research Partners, LLC
Oakland, California, United States
Anderson Clinical Research
Redlands, California, United States
BreakThrough Clinical Trials, LLC
San Bernardino, California, United States
MCB Clinical Research Centers
Colorado Springs, Colorado, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, United States
Scientific Clinical Research, Inc.
North Miami, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Atlanta Institute of Medicine & Research
Atlanta, Georgia, United States
Pedia Research
Newburgh, Indiana, United States
Heartland Research Associates
Wichita, Kansas, United States
Louisiana Clinical Research, LLC
Shreveport, Louisiana, United States
Comprehensive Psychiatric Associates
Gladstone, Missouri, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, United States
Mercy Health Research
St Louis, Missouri, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Brooklyn Medical Institute
Brooklyn, New York, United States
Medical & Behavioral Health Research, PC
New York, New York, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Belmont Center for Comprehensive Treatment
Philadelphia, Pennsylvania, United States
Medical University South Carolina Anxiety Disorder Program
North Charleston, South Carolina, United States
Psychiatric Consultants, PC
Franklin, Tennessee, United States
Research Strategies of Memphis, LLC
Memphis, Tennessee, United States
KRK Medical Research
Dallas, Texas, United States
Future Search Trials of Dallas, LP
Dallas, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Dr Lieven De Weirdt
Sint-Niklaas, , Belgium
Saint Anne s.r.o.
Brno, , Czechia
Psychiatricka ambulance
Brno, , Czechia
Medicana s.r.o.
Hořovice, , Czechia
Psychiatrie s.r.o.
Kutná Hora, , Czechia
Bialbi s.r.o.
Litoměřice, , Czechia
Clintrial s.r.o.
Prague, , Czechia
Psychiatry Trial s.r.o.
Prague, , Czechia
Prague Medical Services s.r.o.
Prague, , Czechia
Ricany s.r.o.
Říčany, , Czechia
Parnu Hospital, Psychiatric Clinic
Pärnu, , Estonia
North Estonia Medical Centre Foundation Psychiatry Clinic
Tallinn, , Estonia
Marienthal Psychiatry and Psychology Center
Tallinn, , Estonia
Jaanson & Laane OU
Tartu, , Estonia
Tartu University Hospital Psychiatric Clinic
Tartu, , Estonia
ARTES Psykiatrinen Palvelukeskus Oy
Helsinki, , Finland
Satucon Oy
Kuopio, , Finland
Satakunnan Psykiatripalveiu Oy at Mentoria Oy
Tampere, , Finland
Puutorin Psykiatripalvelu
Turku, , Finland
Gemeinschafstpraxis für Neurologie und Psychiatrie, Psychotherapie
Achim, , Germany
Private Praxis Dr. Jana Thomsen
Berlin, , Germany
emovis GmbH
Berlin, , Germany
Alexander Schulze, MD
Berlin, , Germany
Private Practice Drs. Bitter/Schumann
Bochum, , Germany
University Hospital Carl Gustav Carus
Dresden, , Germany
ZSL Zentrum fuer medizinische Studien in Leipzig
Leipzig, , Germany
Studienzentrum Muenchen
München, , Germany
Universitaetsklinikum Munster
Münster, , Germany
Studienzentrum Klinikum Nuernberg
Nuremberg, , Germany
Somni bene GmbH
Schwerin, , Germany
Private Practice: Eugen Schlegel
Siegen, , Germany
Studiezentrum Nord-West
Westerstede, , Germany
Medizinisches Studienzentrum Wuerzburg
Würzburg, , Germany
Semmelweis Univ. Dept.of Psychiatry
Budapest, , Hungary
Debrecent Egyetem Orvos es Egeszsegtudomanyl Centrum Pszichiatrai
Debrecen, , Hungary
Santha Kalman Mentalis Egeszsegkozpont es Szakkorhaz
Nagykálló, , Hungary
Josa Andras Teaching Hospital
Nyíregyháza, , Hungary
Pecsi Tudomanyegyeiem Pszichiatriai es Pszichoterapias Klinika
Sziget, , Hungary
Prywatne Gabinety Lekarskie "Promedicus"
Bialystok, , Poland
NZOZ Centrum Kultury, Higieny i Zdrowia Psychicznego
Bydgoszcz, , Poland
Zespol Opieki Zdrowotnej w Chelmnie
Chełmno, , Poland
Centrum Badan Klinicznuch Pl-House sp. z.o.o.
Gdansk, , Poland
Klinika Chorob Psychicznych i Zaburzen Nerwicowych
Gdansk, , Poland
Centrum Psychiatrii i Psychoterapli
Gorlice, , Poland
NZOZ Syntonia, Poradnia Zdrowia Psychicznego
Kielce, , Poland
Osrodek Badafi Klinicznych Prof dr hab n med Meszek Szczepanski Prywatna Praktyka Lekarska
Lublin, , Poland
Samodzielny Publiczny Zespol Zakladow Opieki Zdrowotnej w Zurominie
Żuromin, , Poland
Spitatul Clinic Judetean de Urgenta Arad, Clinica de Psihiatrie
Arad, , Romania
Stefi-Dent SRL
Botoșani, , Romania
Spitalui Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia" Sectia Clinica Psihiatrie I
Bucharest, , Romania
Crucea Alba
Oradea, , Romania
Lorentina 2201 SRL
Târgovişte, , Romania
Spitalul Clinic Judetean Mures
Târgu Mureş, , Romania
Cape Trial Centre
Bellville, Cape Town, South Africa
Flexivest Fourteen Research Centre
Bellville, Cape Town, South Africa
Private Practice - Gerta Brink
Johannesburg, Gauten, South Africa
Somerset West Clinical Research
Somerset West, Western Cape, South Africa
Vista Clinic
Centurion, , South Africa
George Medi Clinic Extension
George, , South Africa
SU/ Affektiva 1
Gothenburg, , Sweden
ProbarE i Lund AB
Lund, , Sweden
Ekdahl Medical AB
Malmo, , Sweden
INM Psykiatrisk Mottagning
Malmo, , Sweden
Medinstructor Lippitz AB
Stockholm, , Sweden
Dr. Wahlstedts mottagning
Uppsala, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-003006-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPD489-323
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.