drugset / Trial / NCT01436175
SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study
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
Outcome
Outcome not reported
Stopped: “SPD489 failed to demonstrate a benefit as adjunctive treatment to antidepressants. Termination was not related to any new safety findings.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — | — |