drugset / Trial / NCT01034462
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive disorder
Timeline
- Start
- 2009-12
- Primary completion
- 2011-12
- Completion
- 2011-12
Publications
- Wesnes KA, Gommoll C, Chen C, Sambunaris A, McIntyre RS, Harvey PD. Effects of levomilnacipran extended-release on major depressive disorder patients with cognitive impairments: post-hoc analysis of a phase III study. Int Clin Psychopharmacol. 2017 Mar;32(2):72-79. doi: 10.1097/YIC.0000000000000157.
- Cutler AJ, Gommoll CP, Chen C, Greenberg WM, Ruth A. Levomilnacipran Extended-Release Treatment in Patients With Major Depressive Disorder: Improvements in Functional Impairment Categories. Prim Care Companion CNS Disord. 2015 Jun 11;17(3):10.4088/PCC.14m01753. doi: 10.4088/PCC.14m01753. eCollection 2015.
- Sambunaris A, Bose A, Gommoll CP, Chen C, Greenberg WM, Sheehan DV. A phase III, double-blind, placebo-controlled, flexible-dose study of levomilnacipran extended-release in patients with major depressive disorder. J Clin Psychopharmacol. 2014 Feb;34(1):47-56. doi: 10.1097/JCP.0000000000000060.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levomilnacipran | Small molecule | 40 mg | Oral |
| Subject | Levomilnacipran | Small molecule | 120 mg | Oral |