NCT00905424

Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant

A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Exploratory Efficacy and Safety Study of SPD489 in Adults 18-55 Years With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of SPD489 when used as augmentation to an antidepressant in the treatment of major depressive disorder (MDD) as measured by mean change in total Montgomery-Ǻsberg Depression Rating Scale (MADRS) scores.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Antidepressant + SPD489 (lisdexamfetamine dimesylate)	Escitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks
DRUG	Antidepressant + placebo	Escitalopram oxalate (antidepressant) 20 mg/day oral + placebo oral once daily for 6 weeks

Timeline

• Start date: 2009-07-30
• Primary completion: 2010-08-04
• Completion: 2010-08-04
• First posted: 2009-05-20
• Last updated: 2021-06-14
• Results posted: 2011-07-14

Locations

15 sites across 1 country: United States