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

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

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

Summary

Timeline

Publications

Drugs

Indications