NCT00985725

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

Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults With Clinically Significant, Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	SPD489 (Lisdexamfetamine dimesylate)	Oral, 20, 30, 40, 50, 60, and 70mg capsules, once daily
DRUG	Matching placebo	oral, once daily

Timeline

• Start date: 2009-10-29
• Primary completion: 2011-04-18
• Completion: 2011-04-18
• First posted: 2009-09-28
• Last updated: 2021-06-08
• Results posted: 2012-04-06

Locations

33 sites across 1 country: United States