SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
NCT ID: NCT01435759
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
PHASE2
1197 participants
INTERVENTIONAL
2011-05-31
2014-01-17
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 SPD489 help patients with depression who are also 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 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study
NCT01436175
Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
NCT01436162
SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder
NCT00985725
Study of Antidepressant Efficacy of a Selective, High Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder (AMDD)
NCT00759395
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 10 mg
Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg
Antidepressant + SPD489 oral, 10 mg, once daily for 8 weeks
Antidepressant + SPD489 30 mg
Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg
Antidepressant + SPD489 oral, 30 mg, once daily for 8 weeks
Antidepressant + SPD489 50 mg
Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg
Antidepressant + SPD489 oral, 50 mg, once daily for 8 weeks
Antidepressant + SPD489 70 mg
Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg
Antidepressant + SPD489 oral, 70 mg, once daily for 8 weeks
Antidepressant + Placebo
Antidepressant + 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) 10 mg
Antidepressant + SPD489 oral, 10 mg, once daily for 8 weeks
Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg
Antidepressant + SPD489 oral, 30 mg, once daily for 8 weeks
Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg
Antidepressant + SPD489 oral, 50 mg, once daily for 8 weeks
Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg
Antidepressant + SPD489 oral, 70 mg, once daily for 8 weeks
Antidepressant + 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 18-65 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 (HCG) pregnancy test and a negative urine pregnancy test and agrees to comply with any applicable contraceptive requirements.
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 comorbid 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 that may place them at increased vulnerability to the sympathomimetic effects of a stimulant medication.
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 at the Screening Visit.
16. Subject has a history of moderate to severe hypertension.
17. Current use of any other medication (including over-the-counter \[OTC\], herbal or homeopathic preparations) that has central nervous system effects.
18. Subject has the potential to 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 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 or hypersensitivity to any of the possible antidepressant treatments (escitalopram oxalate or venlafaxine HCL extended release.
22. Subject has a positive urine drug result.
23. Subject has a body mass index of \<18.5 or \>40.
24. Subject is female and is pregnant or nursing.
25. Subject has participated in another clinical study involving SPD489/NRP104 or has previously used commercial lisdexamfetamine dimesylate.
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.
Arkansas Psychiatric Clinic Clinical Research Trials
Little Rock, Arkansas, United States
South Coast Clinical Trials
Anaheim, California, United States
Catalina Research Institute, LLC
Chino, California, United States
Shanti Clinical Trials
Colton, California, United States
Clinical Innovation, Inc.
Costa Mesa, California, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States
Irvine Center for Clinical Research
Irvine, California, United States
Omega Clinical Trials
La Habra, California, United States
Provate Practice of Andrew Leuchter, MD
Los Angeles, California, United States
PCSD - Feighner Research
San Diego, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Neuropsychiatric Research Center of Orange County
Santa Ana, California, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States
Western Affiliated Research Institute
Denver, Colorado, United States
Connecticut Clinical Research
Cromwell, Connecticut, United States
Institute of Living
Hartford, Connecticut, United States
The Hospital of Central Connecticut, Psychiatry & Behavioral Health Research
New Britain, Connecticut, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Private Practice - Amit Vijapura MD
Jacksonville, Florida, United States
Psychiatric Associates
Lake City, Florida, United States
Comprehensive Neuroscience, Inc.
Miramar, Florida, United States
Fideltiy Clinical Research, Inc.
North Miami, Florida, United States
Ali A. Kashfi, MD, PA
Orlando, Florida, United States
Clinical Research of Central Florida
Winter Haven, Florida, United States
Kolin Research Group
Winter Park, Florida, United States
Institute for Behavioral Medicine, LLC
Smyrna, Georgia, United States
Treatment Research Center, Rush University Medical Center
Chicago, Illinois, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States
Psychiatric Medicine Associates, LLC
Skokie, Illinois, United States
Sleep and Behavior Medicine Institute
Vernon Hills, Illinois, United States
Clinical Trials Technology, Inc.
Prairie Village, Kansas, United States
Pedia Research, LLC
Owensboro, Kentucky, United States
Psyichatric Care and Research Center
O'Fallon, Missouri, United States
Mid-America Clinical Research, LLC
St Louis, Missouri, United States
Premier Psychiatric Research Institute, LLC.
Lincoln, Nebraska, United States
Clinical Research Consortium
Las Vegas, Nevada, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, United States
CRI Worldwide LLC
Willingboro, New Jersey, United States
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, United States
Clinlabs, Inc.
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Private Practice - Daniel I. Rifkin MD PC
West Seneca, New York, United States
Clinical Trials of America, Inc.
Hickory, North Carolina, United States
North Coast Clinical Trials, Inc.
Beachwood, Ohio, United States
Ohio State University, Dept. of Psychiatry
Columbus, Ohio, United States
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University Services
West Chester, Pennsylvania, United States
Pillar Clinical Research, LLC
Dallas, Texas, United States
Bay Area Clinical Services
Friendswood, Texas, United States
Houston Clinical Trials, LLC
Houston, Texas, United States
Wharton Research Center, Inc.
Wharton, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
Alliance Research Group
Richmond, Virginia, United States
Dean Foundation for Health, Research and Education, Inc.
Middleton, Wisconsin, United States
Independent Psychiatric Consultants, SC, dba, IPC Research
Waukesha, Wisconsin, United States
Instituto Nacional de Psicopatologia
Buenos Aires, , Argentina
Cervino
Buenos Aires, , Argentina
Centro Medico de Medicina Familiar Mind Out Research
CABA, , Argentina
BA Psychiatric Research Center
CABA, , Argentina
Instituto Medico SAMIC
Córdoba, , Argentina
Peninsula Health Mental Health Services
Frankston, Victoria, Australia
Neurotherapy Victoria
Malvern, Victoria, Australia
The Alfred, Monash Alfred Psychiatry Research Centre
Melbourne, Victoria, Australia
The Melbourne Clinic
Richmond, Victoria, Australia
Lyell McEwin Hospital, Mental Health Clinical Trials Unit
Elizabeth Vale, , Australia
Psocomed Estudios Medicos
Antofagasta, Il Region, Chile
Especialidades Medicas L y S
Las Condes, Santiago Metropolitan, Chile
Centro de Estudios y Tratemiento de Enfermedades Psiquiatricas
Las Condes, Santiago Metropolitan, Chile
Biomedica Research Group
Providencia, Santiago Metropolitan, Chile
Centro de Estudios Clinicos
Providencia, Santiago Metropolitan, Chile
Unidad de Salud Mental y Psiquietriea Hospital y CRS El Pino
San Bernardo, Santiago Metropolitan, Chile
Hospital Barros Luco Trudsau
San Miguel, Santiago Metropolitan, Chile
Hollins Park Hospital
Winwick, Warrington Cheshire, United Kingdom
Radbourne Unit
Derby, , United Kingdom
ADHD Mental Health Research Unit
Horsham, , United Kingdom
Newcastle University, Wolfson Research Centre
Newcastle upon Tyne, , United Kingdom
Rushcliffe Mental Health Team
Nottingham, , United Kingdom
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, Iosifescu DV, Mago R, Sarkis E, Reynolds J, Geibel B, Dauphin M. A randomized, double-blind, placebo-controlled, dose-ranging study of lisdexamfetamine dimesylate augmentation for major depressive disorder in adults with inadequate response to antidepressant therapy. J Psychopharmacol. 2017 Sep;31(9):1190-1203. doi: 10.1177/0269881117722998. Epub 2017 Aug 31.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-003615-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPD489-209
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.