Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)

Phase 3 Completed 683 enrolled H. Lundbeck A/S Takeda · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

Investigation of the efficacy and safety of a new potential treatment of Major depressive disorder (MDD) in paediatric participants (age 7 to 11 years).

Timeline

Start: 2016-05-18
Primary completion: 2022-01-21
Completion: 2022-01-21

Outcome

Missed primary endpoint

registry analysis (other test); Double-Blind: Placebo vs Vortioxetine Average (Avg. VOR); p = 0.0937; Mean Difference (Final Values) -2.09 (95% CI -4.54 to 0.36); Mixed Models Analysis NCT02709655 ↗

Publications

Huss M, Findling RL, DelBello MP, Necking O, Petersen ML, Schmidt SN, Rosen M. Vortioxetine for Major Depressive Disorder in Children: 12-Week Randomized, Placebo-Controlled Study. JAACAP Open. 2024 Nov 22;3(3):736-748. doi: 10.1016/j.jaacop.2024.11.002. eCollection 2025 Sep.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Fluoxetine	Small molecule	20 mg	Oral
Subject	Vortioxetine	Unknown	10 mg	Oral
Subject	Vortioxetine	Unknown	20 mg	Oral