Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 143
Healthy volunteers: no

Brief summary:
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).

Detailed description:

Arms:
arm 1: SPD489 arm 2: Placebo

Interventions: intervention 1: SPD489 (Lisdexamfetamine dimesylate) intervention 2: Matching placebo
Intervention descriptions: intervention 1: Oral, 20, 30, 40, 50, 60, and 70mg capsules, once daily intervention 2: oral, once daily

Protocol document: