Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder

Summary

The objective of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran compared with placebo in pediatric outpatients (7-17 years) with major depressive disorder (MDD).

Timeline

Start

2018-07-06

Primary completion

2021-03-01

Completion

2021-03-01

Outcome

Missed primary endpoint

registry Placebo vs Levomilnacipran ER 40-80 mg/Day; p = 0.2215; Least Square Mean Difference -1.7 (95% CI -4.49 to 1.04) NCT03569475 ↗

paper Similarly, in LVM-MD-14, there were no significant differences in LSM change in CDRS-R total score with placebo (-21.3) versus levomilnacipran 40 to 80 mg daily (-23.0; p = 0.2215). PMID 38700708 ↗

Publications

• Radecki DT, Robieson WZ, Gopalkrishnan M, Greenberg E, Aziz M. Safety and Efficacy of Levomilnacipran Extended Release in Pediatric Patients Aged 7-17 Years with Major Depressive Disorder: Results of Two Phase 3, Randomized, Double-Blind Studies. J Child Adolesc Psychopharmacol. 2024 Jun;34(5):241-250. doi: 10.1089/cap.2023.0080. Epub 2024 May 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Fluoxetine	Small molecule	20 mg	Oral
Subject	Levomilnacipran	Small molecule	40 mg	Oral
Subject	Levomilnacipran	Small molecule	80 mg	Oral

Indications