Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant
NCT ID: NCT00905424
Last Updated: 2021-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
246 participants
INTERVENTIONAL
2009-07-30
2010-08-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active
Antidepressant + SPD489
Antidepressant + SPD489 (lisdexamfetamine dimesylate)
Escitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks
Placebo
Antidepressant + placebo
Antidepressant + placebo
Escitalopram oxalate (antidepressant) 20 mg/day oral + placebo oral once daily for 6 weeks
Interventions
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Antidepressant + SPD489 (lisdexamfetamine dimesylate)
Escitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks
Antidepressant + placebo
Escitalopram oxalate (antidepressant) 20 mg/day oral + placebo oral once daily for 6 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
55 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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Pharmacology Research Institute (PRI)
Newport Beach, California, United States
Affiliated Research Institute
San Diego, California, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Atlanta Institute of Medicine & Research
Atlanta, Georgia, United States
Carman Research
Smyrna, Georgia, United States
Vince & Associates Clinical Research
Overland Park, Kansas, United States
Duke University Medical Center
Durham, North Carolina, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Summit Research Network
Portland, Oregon, United States
FutureSearch Clinical Trials, LP
Austin, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Summit Research Network (Seattle), LLC
Seattle, Washington, United States
Countries
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References
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Trivedi MH, Cutler AJ, Richards C, Lasser R, Geibel BB, Gao J, Sambunaris A, Patkar AA. A randomized controlled trial of the efficacy and safety of lisdexamfetamine dimesylate as augmentation therapy in adults with residual symptoms of major depressive disorder after treatment with escitalopram. J Clin Psychiatry. 2013 Aug;74(8):802-9. doi: 10.4088/JCP.13m08360.
Related Links
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FDA Recall Information
Other Identifiers
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SPD489-203
Identifier Type: -
Identifier Source: org_study_id
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