Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)

Phase 3 Completed 784 enrolled H. Lundbeck A/S Takeda · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) diagnosis of Major depressive disorder (MDD).

Timeline

Start: 2016-05
Primary completion: 2019-07-02
Completion: 2019-07-30

Outcome

Missed primary endpoint

paper The primary endpoint was not met, thereby rendering the study negative. PMID 35033635 ↗

registry analysis (superiority test); Placebo vs Vortioxetine Average (Avg. VOR); p = 0.8778; Mean Difference (Final Values) 0.21 (95% CI -2.41 to 2.82); Mixed Model Repeated Analysis NCT02709746 ↗

Publications

Findling RL, DelBello MP, Zuddas A, Emslie GJ, Ettrup A, Petersen ML, Schmidt SN, Rosen M. Vortioxetine for Major Depressive Disorder in Adolescents: 12-Week Randomized, Placebo-Controlled, Fluoxetine-Referenced, Fixed-Dose Study. J Am Acad Child Adolesc Psychiatry. 2022 Sep;61(9):1106-1118.e2. doi: 10.1016/j.jaac.2022.01.004. Epub 2022 Jan 13.

Drugs

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