drugset / Trial / NCT01436175

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

NCT01436175

Phase 3 Terminated 1570 enrolled Shire
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2012-02-27
Primary completion
2014-03-27
Completion
2014-03-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Lisdexamfetamine Dimesylate Small molecule 20 mg Oral
Subject Lisdexamfetamine Dimesylate Small molecule 30 mg Oral
Subject Lisdexamfetamine Dimesylate Small molecule 50 mg Oral
Subject Lisdexamfetamine Dimesylate Small molecule 70 mg Oral
Background Duloxetine Small molecule
Background Escitalopram Small molecule
Background Sertraline Small molecule
Background Venlafaxine Small molecule