drugset / Trial / NCT00969150
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
- 2009-09
- Primary completion
- 2010-11
- Completion
- —
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Placebo vs Levomilnacipran ER; p = 0.2492; Least squares mean difference -1.49 (95% CI -4.02 to 1.05); Mixed Models Analysis NCT00969150 ↗
paper For levomilnacipran ER vs placebo, MADRS (-15.7 vs -14.2) and SDS (-8.8 vs -8.2) total score improvements, and rates of MADRS response (38.5% vs 34.8%) and remission (25.3% vs 23.8%) were numerically greater but differences were not statistically significant. PMID 27536449 ↗
Publications
- Gommoll CP, Greenberg WM, Chen C. A randomized, double-blind, placebo-controlled study of flexible doses of levomilnacipran ER (40-120 mg/day) in patients with major depressive disorder. J Drug Assess. 2014 Jan 16;3(1):10-9. doi: 10.3109/21556660.2014.884505. eCollection 2014.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levomilnacipran | Small molecule | 40 mg | Oral |
| Subject | Levomilnacipran | Small molecule | 120 mg | Oral |