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
- Can supplemental SPD489 help patients who still have residual depression symptoms while
- How much SPD489 should be given to patients with depression who are also taking an
- How does SPD489 compare to placebo in depressed patients who are also taking an
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Inclusion Criteria:
- Subject is able to provide written, personally signed, and dated informed consent to
participate in the study.
- 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 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.
- 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.
ALPHA Recherche Clinique, Quebec G3K 2P8, Canada
Poliklinika Neuron, Zagreb 10 000, Croatia
Psychiatric Clinic Vrapoe, Zagreb 10090, Croatia
Hospital Aranda de la Parra, Leon Guanajuato 37000, Mexico
Instituto de Infromacion e Investigación en Salud Mental (INFOSAME), Nuevo Leon 64710, Mexico
Consultorio Especializado en Psiquiatria Infantil y Adolescentes, San Luis Potosi 78200, Mexico
B & B Investigaciones Medicas S.C., Sinaloa 82126, Mexico
Dharma Institute & Research Center, San Juan 00907, Puerto Rico
INSPIRA Clinical Research, San Juan 00918, Puerto Rico
Hospital de la Santa Creo l Sant Pau, Barcelona 08025, Spain
Hospital Universitari de Bellvitge, Servicio de Psiquiatria, Barcelona 08907, Spain
Hospital Fundacion de Alcorcon, Madrid 28922, Spain
Hospital Universitario de Henares, Madrid, Spain
Hospital Universitario Infanta Leonor, Madrid 28031, Spain
Centro de Salud Mental Il la Corredoria, Oviedo 33011, Spain
Centro Salud Alamedilla Unidad de Salud Mental, Salamanca 37003, Spain
Complejo hospitalario de Zamora, Zamora 49021, Spain
Hospital Clinico Universitario Lozano Blesa, Zaragoza 50009, Spain
Birmingham Research Group, Birmingham, Alabama 35216, 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
AV Institue, Inc., Carson, California 90746, United States
University of California, Irvine Child Development Center, Irvine, California 92612, United States
South Coast Clinicals, Norwalk, California 90650, United States
North County Clinical Research, Oceanside, California 92056, United States
Pasadena Research Institute, LLC, Pasadena, California 91106, United States
Affiliated Research Institute, 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
Geriatric and Adult Psychiatry, LLC, Hamden, Connecticut 06518, United States
Middlexex Hospital Center for Behavioral Health, Middletown, Connecticut 06457, United States
CNS Clinical Research Group, Coral Springs, Florida 33067, United States
Emerald Coast Mood & Memory, PA, Fort Walton Beach, Florida 32547, United States
Florida Clinical Research Center, LLC., Maitland, Florida 32751, United States
Suncoast Clinical Research, New Port Richey, Florida 34652, United States
Compass Research, LLC, Orlando, Florida 32806, United States
Meridien Research, St. Petersburg, Florida 33709, United States
Stedman Clinical Trials, Tampa, Florida 33613, United States
Carman Research, Smyrna, Georgia 30080, United States
American Medical Research, Inc., Oak Brook, Illinois 60523, United States
The Davis Clinic, Indianapolis, Indiana 46260, United States
Northwest Indiana Center for Clinical Research, Valparaiso, Indiana 46383, United States
MCM Clinical Research LLC, Florence, Kentucky 41042, 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
St. Charles Psychiatric Associates - Midwest Research Group, St. Charles, Missouri 63301, United States
Bioscience Research, LLC, Mt. Kisco, New York 10549, United States
Fieve Clinical Research, New York, New York 10168, United States
Richmond Behavioral Associates, Staten Island, New York 10312, United States
Triangle Neuropsychiatry, Durham, North Carolina 27707, United States
Rcihard H. Weisler, MD, PA & Associates, Raleigh, North Carolina 27809, United States
Centro Regiomontano de Investigacion S.C. (CRI), Monterrey, Nuevo Leon 647-10, Mexico
Community Research, Cincinatti, Ohio 45227, United States
Lindner Center of HOPE, Mason, Ohio 45040, United States
SP Research, PLLC, Oklahoma City, Oklahoma 73112, United States
Aggarwal & Associates Ltd., Brampton, Ontario L6T 0G1, Canada
Depression, Mood Disorders and Schizophrenia Treatment Centre, Burlington, Ontario L7R 4E2, Canada
Chatham-Kent Clinical Trials Research Center, Chatham, Ontario N7M 5L9, Canada
Regional Mental Health Care, London, Ontario N6A 4H1, Canada
Anxiety and Mood Disorder Center, Mississauga, Ontario L5M 4N4, Canada
Medical Research Associates, Mississauga, Ontario L5M 4N4, Canada
A.K. Karan Holdings, Oakville, Ontario L6J0B2, Canada
International Sleep Clinic, West Parry Sound Health Centre, Parry Sound, Ontario P2A 3A4, Canada
Manna Research, Toronto, Ontario M9W 4L6, Canada
Sleep & Alertness Clinic (Sleep & Alertness Research, Inc.), Toronto, Ontario M6J 3S3, Canada
START Clinic for Mood and Anxiety Disorders, Toronto, Ontario M4W 2N4, Canada
Univ Health Network, Toronto Western Hospital, Toronto, Ontario M5T2S8, Canada
Windsor Regional Hospital-Tayfour Campus, Windsor, Ontario N9C 3Z4, Canada
Summit Research Network (Oregon) Inc., Portland, Oregon 97210, United States
Paramount Clinical Research, Bridgeville, Pennsylvania 15107, United States
Suburban Research Associates, Media, Pennsylvania 19063, United States
CRI Worldwide LLC, Philadelphia, Pennsylvania 19139, United States
University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania 15213, United States
Pierre-Janet Hospital, Gatineau, Quebec J8A1K7, 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, Sherbrooke, Quebec J1H 4J6, Canada
Rhode Island Mood & Memory Research Institute, East Providence, Rhode Island 02914, United States
Clinical Neuroscience Solutions, Inc., Memphis, Tennessee 38119, United States
Clinical Research Associates, Nashville, Tennessee 37203, United States
FutureSearch Clinical Trials, LP, Austin, Texas 78731, United States
Ericksen Research and Development, Clinton, Utah 84015, United States
Summit Research Network (Seattle) LLC, Seattle, Washington 98104, United States