SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

To evaluate the efficacy of SPD489 for the treatment of executive function impairments (EFI) when used as an adjunct to stable, standard therapy in the setting of partial or full remission from recurrent Major Depressive Disorder (MDD) as measured by the Global Executive Composite (GEC) T-score of the Behavioral Rating Inventory of Executive Functioning - Adult Version (BRIEF-A).

Key facts

Study ID

NCT00985725

Run by

Shire

People needed

143

Starts

2009-10-29

Expected to finish

2011-04-18

Last updated by the study team

2021-06-08

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18-55 with a primary diagnosis of nonpsychotic uni-polar depression

You may not qualify if…

• Current co-morbid psychiatric disorder

Where it is running

• Sun Valley Research Center — Imperial, California, United States
• Pharmacology Research Center — Los Alamitos, California, United States
• Excell Research — Oceanside, California, United States
• Neuropsychiatric Resesarch Center of Orange County — Santa Ana, California, United States
• Connecticut Clincal Research — Cromwell, Connecticut, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Amit Vijapura, MD — Jacksonville, Florida, United States
• Scientific Clinical Research, Inc. — North Miami, 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
• Joliet Center for Clinical Research — Joliet, Illinois, United States
• Capstone Clinical Research — Libertyville, Illinois, United States
• Psychiatric Associates — Overland Park, Kansas, United States
• AccelRx Research — Fall River, Massachusetts, United States
• St. Charles Psychiatric Associates — Saint Charles, Missouri, United States
• PsychCare Consultants Research — St Louis, Missouri, United States
• Premier Psychiatric Research Institute, LLC — Lincoln, Nebraska, United States
• Richmond Behavioral Associates — Staten Island, New York, United States
• North Carolina Neuropsychiatry, PA — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Richard H. Weisler, MD, PA & Associates — Raleigh, North Carolina, United States
• Patient Priority Clinical Sites, LLC — Cincinnati, Ohio, United States
• Lehigh Center for Clinical Research — Allentown, Pennsylvania, United States
• Paramount Clinical Research — Bridgeville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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