Major Depressive Disorder Clinical Trial
Official title:
A Phase 2, Multicenter, Double- Blind, Parallel-group, Randomized, Placebo-controlled, Forced-dose Titration, Dose-ranging 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
Verified date | May 2021 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. 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 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?
Status | Completed |
Enrollment | 1197 |
Est. completion date | January 17, 2014 |
Est. primary completion date | January 17, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria 1. Subject is able to provide written, personally signed and dated informed consent to participate in the study before completing any study-related procedures. 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 1. Subject whose current episode of MDD has not responded to an adequate treatment regimen. 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. |
Country | Name | City | State |
---|---|---|---|
Argentina | Cervino | Buenos Aires | |
Argentina | Instituto Nacional de Psicopatologia | Buenos Aires | |
Argentina | BA Psychiatric Research Center | Caba | |
Argentina | Centro Medico de Medicina Familiar Mind Out Research | Caba | |
Argentina | Instituto Medico SAMIC | Cordoba | |
Australia | Lyell McEwin Hospital, Mental Health Clinical Trials Unit | Elizabeth Vale | |
Australia | 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 |
Chile | Psocomed Estudios Medicos | Antofagasta | Il Region |
Chile | Centro de Estudios y Tratemiento de Enfermedades Psiquiatricas | Las Condes | Santiago |
Chile | Especialidades Medicas L y S | Las Condes | Santiago |
Chile | Biomedica Research Group | Providencia | Santiago |
Chile | Centro de Estudios Clinicos | Providencia | Santiago |
Chile | Unidad de Salud Mental y Psiquietriea Hospital y CRS El Pino | San Bernardo | Santiago |
Chile | Hospital Barros Luco Trudsau | San Miguel | Santiago |
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 | Hollins Park Hospital | Winwick | Warrington Cheshire |
United States | Albuquerque Neuroscience, Inc. | Albuquerque | New Mexico |
United States | South Coast Clinical Trials | Anaheim | California |
United States | North Coast Clinical Trials, Inc. | Beachwood | Ohio |
United States | Montefiore Medical Center | Bronx | New York |
United States | Center for Emotional Fitness | Cherry Hill | New Jersey |
United States | Treatment Research Center, Rush University Medical Center | Chicago | Illinois |
United States | Catalina Research Institute, LLC | Chino | California |
United States | Shanti Clinical Trials | Colton | California |
United States | Ohio State University, Dept. of Psychiatry | Columbus | Ohio |
United States | Clinical Innovation, Inc. | Costa Mesa | California |
United States | Connecticut Clinical Research | Cromwell | Connecticut |
United States | Pillar Clinical Research, LLC | Dallas | Texas |
United States | Western Affiliated Research Institute | Denver | Colorado |
United States | Gulfcoast Clinical Research Center | Fort Myers | Florida |
United States | Bay Area Clinical Services | Friendswood | Texas |
United States | Sarkis Clinical Trials | Gainesville | Florida |
United States | Collaborative Neuroscience Network, Inc. | Garden Grove | California |
United States | Institute of Living | Hartford | Connecticut |
United States | Clinical Trials of America, Inc. | Hickory | North Carolina |
United States | Alexian Brothers Center for Psychiatric Research | Hoffman Estates | Illinois |
United States | Houston Clinical Trials, LLC | Houston | Texas |
United States | Irvine Center for Clinical Research | Irvine | California |
United States | Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida |
United States | Private Practice - Amit Vijapura MD | Jacksonville | Florida |
United States | Omega Clinical Trials | La Habra | California |
United States | Psychiatric Associates | Lake City | Florida |
United States | Clinical Research Consortium | Las Vegas | Nevada |
United States | Premier Psychiatric Research Institute, LLC. | Lincoln | Nebraska |
United States | Arkansas Psychiatric Clinic Clinical Research Trials | Little Rock | Arkansas |
United States | Provate Practice of Andrew Leuchter, MD | Los Angeles | California |
United States | Dean Foundation for Health, Research and Education, Inc. | Middleton | Wisconsin |
United States | Comprehensive Neuroscience, Inc. | Miramar | Florida |
United States | The Hospital of Central Connecticut, Psychiatry & Behavioral Health Research | New Britain | Connecticut |
United States | Clinlabs, Inc. | New York | New York |
United States | Mount Sinai School of Medicine | New York | New York |
United States | Fideltiy Clinical Research, Inc. | North Miami | Florida |
United States | Psyichatric Care and Research Center | O'Fallon | Missouri |
United States | IPS Research Company | Oklahoma City | Oklahoma |
United States | Ali A. Kashfi, MD, PA | Orlando | Florida |
United States | Pedia Research, LLC | Owensboro | Kentucky |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | Clinical Trials Technology, Inc. | Prairie Village | Kansas |
United States | Alliance Research Group | Richmond | Virginia |
United States | Mid-America Clinical Research, LLC | Saint Louis | Missouri |
United States | Artemis Institute for Clinical Research | San Diego | California |
United States | PCSD - Feighner 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 | Psychiatric Medicine Associates, LLC | Skokie | Illinois |
United States | Institute for Behavioral Medicine, LLC | Smyrna | Georgia |
United States | Neurology & Neuroscience Center of Ohio | Toledo | Ohio |
United States | Sleep and Behavior Medicine Institute | Vernon Hills | Illinois |
United States | Independent Psychiatric Consultants, SC, dba, IPC Research | Waukesha | Wisconsin |
United States | University Services | West Chester | Pennsylvania |
United States | Private Practice - Daniel I. Rifkin MD PC | West Seneca | New York |
United States | Wharton Research Center, Inc. | Wharton | Texas |
United States | Grayline Clinical Drug Trials | Wichita Falls | Texas |
United States | CRI Worldwide LLC | Willingboro | New Jersey |
United States | Clinical Research of Central Florida | Winter Haven | Florida |
United States | Kolin Research Group | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Shire |
United States, Argentina, Australia, Chile, United Kingdom,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Montgomery-?sberg Depression Rating Scale (MADRS) Total Score From Augmentation Baseline (Week 8) to Week 16 (Double-blind Phase, Dose Response Evaluable Set) | 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. CHange in MADRS total score in Augmentsion Baseline to Week 16. | Augmentation Baseline (Week 8) to Week 16 | |
Secondary | Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16 | From Augmentation Baseline (Week 8) to Week 16 | ||
Secondary | Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16 | From Augmentation Baseline (Week 8) to Week 16 | ||
Secondary | Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16 | From Augmentation Baseline (Week 8) to Week 16 |
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