NCT01436175

SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study

A Phase 3, Open-label, Multicenter, 12-month Extension Safety and Tolerability Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Residual Symptoms or Inadequate Response Following Treatment With an Antidepressant

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,570 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is an optional continuation of previous short-term adult major depressive disorder (MDD) augmentation studies. Patients may only take part in this long-term, open-label research study if they completed a previous double-blind MDD augmentation study using SPD489.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	SPD489 (Lisdexamfetamine dimesylate) + Antidepressant	SPD489 20mg, 30mg, 50mg, or 70mg + Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily for 52 weeks

Timeline

• Start date: 2012-02-27
• Primary completion: 2014-03-27
• Completion: 2014-03-27
• First posted: 2011-09-19
• Last updated: 2021-06-14
• Results posted: 2015-02-23

Locations

212 sites across 14 countries: United States, Canada, Chile, Czechia, Estonia, Finland, Germany, Hungary, Mexico, Poland, Puerto Rico, Romania, South Africa, Spain