Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
NCT ID: NCT01436149
Last Updated: 2021-06-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1262 participants
INTERVENTIONAL
2011-10-27
2013-12-23
Brief Summary
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* 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?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Antidepressant + SPD489
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
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
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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
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
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Eligibility Criteria
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Inclusion Criteria
* Subject is between 18 and 65 years of age.
* Subject has a primary diagnosis of non-psychotic MDD (single or recurrent).
* Subject has a MADRS total score 24.
* Subject who is female, must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test and a negative urine pregnancy test at the and agrees to comply with any applicable contraceptive requirements of the protocol.
* Subject is able to swallow a capsule.
Exclusion Criteria
* Subject who has a lifetime history of treatment resistant depression.
* Subject has a current co-morbid psychiatric disorder. Excluded are: any significant Axis II disorder (including borderline personality disorder), any bipolar disorder, any current or lifetime psychosis, post traumatic stress disorder, obsessive compulsive disorder, any pervasive development disorder, anorexia nervosa and bulimia nervosa.
* 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 in the opinion of the Investigator, 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 a history of moderate to severe hypertension.
* Current use of any other medications (including over-the-counter \[OTC\], herbal or homeopathic preparations) that have central nervous system effects.
* Subject has had electroconvulsive therapy (ECT) for the current depressive episode 3 months prior.
* 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).
* Subject has a positive urine drug result.
* Subject has a body mass index (BMI) of \<18.5 or \>40.
* Subject is female and is pregnant or nursing.
18 Years
65 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Birmingham Research Group
Birmingham, Alabama, United States
AV Institue, Inc.
Carson, California, United States
University of California, Irvine Child Development Center
Irvine, California, United States
South Coast Clinicals
Norwalk, California, United States
North County Clinical Research
Oceanside, California, United States
Pasadena Research Institute, LLC
Pasadena, California, United States
Affiliated Research Institute
San Diego, California, United States
Clinical Innovations, Inc.
San Diego, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
Geriatric and Adult Psychiatry, LLC
Hamden, Connecticut, United States
Middlexex Hospital Center for Behavioral Health
Middletown, Connecticut, United States
CNS Clinical Research Group
Coral Springs, Florida, United States
Emerald Coast Mood & Memory, PA
Fort Walton Beach, Florida, United States
Florida Clinical Research Center, LLC.
Maitland, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Carman Research
Smyrna, Georgia, United States
American Medical Research, Inc.
Oak Brook, Illinois, United States
The Davis Clinic
Indianapolis, Indiana, United States
Northwest Indiana Center for Clinical Research
Valparaiso, Indiana, United States
MCM Clinical Research LLC
Florence, Kentucky, United States
Pharmasite Research, Inc.
Baltimore, Maryland, United States
Potomac Grove Clinical Research Center
Gaithersburg, Maryland, United States
Office of Marc Hertzman, MD
Rockville, Maryland, United States
Adams Clinical Trials, LLC
Watertown, Massachusetts, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, United States
Bioscience Research, LLC
Mount Kisco, New York, United States
Fieve Clinical Research
New York, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Triangle Neuropsychiatry
Durham, North Carolina, United States
Rcihard H. Weisler, MD, PA & Associates
Raleigh, North Carolina, United States
Community Research
Cincinnati, Ohio, United States
Lindner Center of HOPE
Mason, Ohio, United States
SP Research, PLLC
Oklahoma City, Oklahoma, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, United States
Paramount Clinical Research
Bridgeville, Pennsylvania, United States
Suburban Research Associates
Media, Pennsylvania, United States
CRI Worldwide LLC
Philadelphia, Pennsylvania, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Clinical Research Associates
Nashville, Tennessee, United States
FutureSearch Clinical Trials, LP
Austin, Texas, United States
Ericksen Research and Development
Clinton, Utah, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, United States
Dr. Alexander McIntyre Inc
Penticton, British Columbia, Canada
Dr. D. McIntosh & Dr. K. Kjernisted Clinical Research Inc.
Vancouver, British Columbia, Canada
Aggarwal & Associates Ltd.
Brampton, Ontario, Canada
Depression, Mood Disorders and Schizophrenia Treatment Centre
Burlington, Ontario, Canada
Chatham-Kent Clinical Trials Research Center
Chatham, Ontario, Canada
Regional Mental Health Care
London, Ontario, Canada
Anxiety and Mood Disorder Center
Mississauga, Ontario, Canada
Medical Research Associates
Mississauga, Ontario, Canada
A.K. Karan Holdings
Oakville, Ontario, Canada
International Sleep Clinic, West Parry Sound Health Centre
Parry Sound, Ontario, Canada
START Clinic for Mood and Anxiety Disorders
Toronto, Ontario, Canada
Univ Health Network, Toronto Western Hospital
Toronto, Ontario, Canada
Sleep & Alertness Clinic (Sleep & Alertness Research, Inc.)
Toronto, Ontario, Canada
Manna Research
Toronto, Ontario, Canada
Windsor Regional Hospital-Tayfour Campus
Windsor, Ontario, Canada
Pierre-Janet Hospital
Gatineau, Quebec, Canada
l'Hopital Louis H. Lafontaine
Montreal, Quebec, Canada
Kells Medical Research Group Inc.
Pointe-Claire, Quebec, Canada
ALPHA Recherche Clinique
Québec, Quebec, Canada
Q&T Research Sherbrooke
Sherbrooke, Quebec, Canada
Poliklinika Neuron
Zagreb, , Croatia
Psychiatric Clinic Vrapoe
Zagreb, , Croatia
Centro Regiomontano de Investigacion S.C. (CRI)
Monterrey, Nuevo León, Mexico
Hospital Aranda de la Parra
León, , Mexico
Instituto de Infromacion e Investigación en Salud Mental (INFOSAME)
Nuevo León, , Mexico
Consultorio Especializado en Psiquiatria Infantil y Adolescentes
San Luis Potosí City, , Mexico
B & B Investigaciones Medicas S.C.
Sinaloa, , Mexico
Dharma Institute & Research Center
San Juan, , Puerto Rico
INSPIRA Clinical Research
San Juan, , Puerto Rico
Hospital de la Santa Creo l Sant Pau
Barcelona, , Spain
Hospital Universitari de Bellvitge, Servicio de Psiquiatria
Barcelona, , Spain
Hospital Universitario Infanta Leonor
Madrid, , Spain
Hospital Fundacion de Alcorcon
Madrid, , Spain
Hospital Universitario de Henares
Madrid, , Spain
Centro de Salud Mental Il la Corredoria
Oviedo, , Spain
Centro Salud Alamedilla Unidad de Salud Mental
Salamanca, , Spain
Complejo hospitalario de Zamora
Zamora, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Countries
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References
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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
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2011-003018-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPD489-322
Identifier Type: -
Identifier Source: org_study_id
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