SPD489-322 phase 3, multicenter, randomized, double-blind, placebo-controlled, flexible dose titration, 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
Tim Wigal, PhD
University of California, Irvine Child Development Center, 19722 MacArthur Blvd., Irvine
The purpose of this research study is to demonstrate the efficacy of SPD489 when used as an add-on medication in the treatment of Major Depressive Disorder (MDD) in inadequate responders following an 8-week course of treatment with an antidepressant.
Adults age 50-89 years old with mild to moderate Alzheimer's disease.
This study will consist for three periods: a screening phase approximately 2-4 weeks in duration, an 8-week lead-in treatment phase and an 8-week double-blind treatment phase. This study involves approximately 15 visits over a 4-5 month period.
Participants will receive an evaluation for a major depressive disorder and careful monitoring of their mood and behavior. All subjects will receive an approved antidepressant. Some subjects will also receive SPD489 in double-blind fashion. These medications may improve symptoms of major depressive disorder. It is possible, however, that no therapeutic or other direct benefits may result during or following completion of this trial.
The participant will be compensated $50 by check for each of 15 visits. If the participant completes some, but not all visits, the amount of compensation will be pro-rated. The participant may receive up to a total of $750 if all visits are completed, to compensate for inconvenience in terms of time and ancillary expenses incurred.
Audrey Kapelinski, UC Irvine Child Development Center