SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: Antidepressant + PlaceboDrug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mgDrug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mgDrug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mgDrug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg
- Registration Number
- NCT01435759
- Lead Sponsor
- Shire
- Brief Summary
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?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1197
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antidepressant + Placebo Antidepressant + Placebo - Antidepressant + SPD489 10 mg Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg - Antidepressant + SPD489 70 mg Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg - Antidepressant + SPD489 30 mg Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg - Antidepressant + SPD489 50 mg Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg -
- Primary Outcome Measures
Name Time Method Change in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score From Augmentation Baseline (Week 8) to Week 16 (Double-blind Phase, Dose Response Evaluable Set) Augmentation Baseline (Week 8) to Week 16 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.
- Secondary Outcome Measures
Name Time Method Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16 From Augmentation Baseline (Week 8) to Week 16 Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16 From Augmentation Baseline (Week 8) to Week 16 Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16 From Augmentation Baseline (Week 8) to Week 16
Trial Locations
- Locations (82)
Arkansas Psychiatric Clinic Clinical Research Trials
🇺🇸Little Rock, Arkansas, United States
Cervino
🇦🇷Buenos Aires, Argentina
Premier Psychiatric Research Institute, LLC.
🇺🇸Lincoln, Nebraska, United States
The Hospital of Central Connecticut, Psychiatry & Behavioral Health Research
🇺🇸New Britain, Connecticut, United States
CRI Worldwide LLC
🇺🇸Willingboro, New Jersey, United States
Connecticut Clinical Research
🇺🇸Cromwell, Connecticut, United States
Mid-America Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
Kolin Research Group
🇺🇸Winter Park, Florida, United States
Alexian Brothers Center for Psychiatric Research
🇺🇸Hoffman Estates, Illinois, United States
Clinical Trials Technology, Inc.
🇺🇸Prairie Village, Kansas, United States
Dean Foundation for Health, Research and Education, Inc.
🇺🇸Middleton, Wisconsin, United States
Ohio State University, Dept. of Psychiatry
🇺🇸Columbus, Ohio, United States
Albuquerque Neuroscience, Inc.
🇺🇸Albuquerque, New Mexico, United States
Instituto Medico SAMIC
🇦🇷Cordoba, Argentina
Provate Practice of Andrew Leuchter, MD
🇺🇸Los Angeles, California, United States
Neuropsychiatric Research Center of Orange County
🇺🇸Santa Ana, California, United States
Private Practice - Amit Vijapura MD
🇺🇸Jacksonville, Florida, United States
Pillar Clinical Research, LLC
🇺🇸Dallas, Texas, United States
Wharton Research Center, Inc.
🇺🇸Wharton, Texas, United States
Rushcliffe Mental Health Team
🇬🇧Nottingham, United Kingdom
Pedia Research, LLC
🇺🇸Owensboro, Kentucky, United States
Centro de Estudios Clinicos
🇨🇱Providencia, Santiago, Chile
Clinical Research of Central Florida
🇺🇸Winter Haven, Florida, United States
Psyichatric Care and Research Center
🇺🇸O'Fallon, Missouri, United States
Independent Psychiatric Consultants, SC, dba, IPC Research
🇺🇸Waukesha, Wisconsin, United States
Clinlabs, Inc.
🇺🇸New York, New York, United States
Instituto Nacional de Psicopatologia
🇦🇷Buenos Aires, Argentina
Clinical Trials of America, Inc.
🇺🇸Hickory, North Carolina, United States
Hollins Park Hospital
🇬🇧Winwick, Warrington Cheshire, United Kingdom
Newcastle University, Wolfson Research Centre
🇬🇧Newcastle upon Tyne, United Kingdom
North Coast Clinical Trials, Inc.
🇺🇸Beachwood, Ohio, United States
Neurology & Neuroscience Center of Ohio
🇺🇸Toledo, Ohio, United States
Unidad de Salud Mental y Psiquietriea Hospital y CRS El Pino
🇨🇱San Bernardo, Santiago, Chile
Hospital Barros Luco Trudsau
🇨🇱San Miguel, Santiago, Chile
Radbourne Unit
🇬🇧Derby, United Kingdom
ADHD Mental Health Research Unit
🇬🇧Horsham, United Kingdom
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Clinical Research Consortium
🇺🇸Las Vegas, Nevada, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
South Coast Clinical Trials
🇺🇸Anaheim, California, United States
Shanti Clinical Trials
🇺🇸Colton, California, United States
Irvine Center for Clinical Research
🇺🇸Irvine, California, United States
Clinical Innovation, Inc.
🇺🇸Costa Mesa, California, United States
Collaborative Neuroscience Network, Inc.
🇺🇸Garden Grove, California, United States
Omega Clinical Trials
🇺🇸La Habra, California, United States
PCSD - Feighner Research
🇺🇸San Diego, California, United States
California Neuroscience Research Medical Group, Inc.
🇺🇸Sherman Oaks, California, United States
Western Affiliated Research Institute
🇺🇸Denver, Colorado, United States
Institute of Living
🇺🇸Hartford, Connecticut, United States
Gulfcoast Clinical Research Center
🇺🇸Fort Myers, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Jacksonville, Florida, United States
Psychiatric Associates
🇺🇸Lake City, Florida, United States
Fideltiy Clinical Research, Inc.
🇺🇸North Miami, Florida, United States
Institute for Behavioral Medicine, LLC
🇺🇸Smyrna, Georgia, United States
Treatment Research Center, Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Psychiatric Medicine Associates, LLC
🇺🇸Skokie, Illinois, United States
Sleep and Behavior Medicine Institute
🇺🇸Vernon Hills, Illinois, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Private Practice - Daniel I. Rifkin MD PC
🇺🇸West Seneca, New York, United States
University Services
🇺🇸West Chester, Pennsylvania, United States
Houston Clinical Trials, LLC
🇺🇸Houston, Texas, United States
BA Psychiatric Research Center
🇦🇷Caba, Argentina
Centro Medico de Medicina Familiar Mind Out Research
🇦🇷Caba, Argentina
The Alfred, Monash Alfred Psychiatry Research Centre
🇦🇺Melbourne, 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, Chile
Centro de Estudios y Tratemiento de Enfermedades Psiquiatricas
🇨🇱Las Condes, Santiago, Chile
Biomedica Research Group
🇨🇱Providencia, Santiago, Chile
Catalina Research Institute, LLC
🇺🇸Chino, California, United States
Ali A. Kashfi, MD, PA
🇺🇸Orlando, Florida, United States
Alliance Research Group
🇺🇸Richmond, Virginia, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Comprehensive Neuroscience, Inc.
🇺🇸Miramar, Florida, United States
Center for Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
Bay Area Clinical Services
🇺🇸Friendswood, Texas, United States
Grayline Clinical Drug Trials
🇺🇸Wichita Falls, Texas, United States
Peninsula Health Mental Health Services
🇦🇺Frankston, Victoria, Australia
Neurotherapy Victoria
🇦🇺Malvern, Victoria, Australia
The Melbourne Clinic
🇦🇺Richmond, Victoria, Australia
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States