drugset / Trial / NCT00735709
Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to determine the effectiveness and safety of vortioxetine, once daily (QD), in patients with Major Depressive Disorder.
Timeline
- Start
- 2008-08
- Primary completion
- 2009-07
- Completion
- 2009-08
Outcome
Met primary endpoint
registry Placebo vs Vortioxetine 10 mg; p <0.001; LS Mean Difference -4.93 (95% CI -6.99 to -2.86) NCT00735709 ↗
Publications
- Background Henigsberg N, Mahableshwarkar AR, Jacobsen P, Chen Y, Thase ME. A randomized, double-blind, placebo-controlled 8-week trial of the efficacy and tolerability of multiple doses of Lu AA21004 in adults with major depressive disorder. J Clin Psychiatry. 2012 Jul;73(7):953-9. doi: 10.4088/JCP.11m07470.
- McIntyre RS, Florea I, Tonnoir B, Loft H, Lam RW, Christensen MC. Efficacy of Vortioxetine on Cognitive Functioning in Working Patients With Major Depressive Disorder. J Clin Psychiatry. 2017 Jan;78(1):115-121. doi: 10.4088/JCP.16m10744.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vortioxetine | Unknown | 1 mg | Oral |
| Subject | Vortioxetine | Unknown | 5 mg | Oral |
| Subject | Vortioxetine | Unknown | 10 mg | Oral |