Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran ER relative to placebo in adolescent outpatients (12-17 years) with Major Depressive Disorder (MDD). In addition, the study is designed to obtain pharmacokinetics (PK) data to guide dose selection for future pediatric studies of levomilnacipran.

Timeline

Start

2015-06-23

Primary completion

2019-08-19

Completion

2019-08-19

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Levomilnacipran 40 mg/Day; p = 0.8035; Least Squares (LS) Mean Difference -0.38 (95% CI -3.41 to 2.64) NCT02431806 ↗

registry analysis (superiority test); Placebo vs Levomilnacipran 80 mg/Day; p = 0.8681; LS Mean Difference 0.26 (95% CI -2.80 to 3.31) NCT02431806 ↗

paper there were no significant differences in change in CDRS-R total score 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