Vortioxetine for Major Depressive Disorder in Adolescents: 12-Week Randomized, Placebo-Controlled, Fluoxetine-Referenced, Fixed-Dose Study

Zuddas, Alessandro;
2022

Abstract

Objective: To evaluate the efficacy and safety of vortioxetine in adolescents with major depressive disorder (MDD). Method: After 4 weeks of single-blind lead-in treatment with a Brief Psychosocial Intervention (BPI) plus placebo, patients (aged 12-17 years) with MDD (DSM-5) who did not meet response criteria (Children's Depression Rating Scale - Revised [CDRS-R]; total score ≥40 plus <40% reduction and a Parent Global Assessment score >2) were randomized 1:1:1:1 to 8 weeks of BPI plus double-blind treatment with vortioxetine 10 mg, vortioxetine 20 mg, fluoxetine 20 mg, or placebo. The primary endpoint was change from randomization in CDRS-R total score at week 8; primary comparison was the average effect of 2 vortioxetine doses versus placebo. Results: Of 784 patients enrolled in the lead-in, 616 were randomized. At week 8, mean change in CDRS-R total score averaged for vortioxetine doses was -18.01 (standard error = 0.98) and mean difference versus placebo was 0.21 (P = .878; not significant). For fluoxetine, mean change in CDRS-R total score was -21.95 and mean difference versus placebo was -3.73 (P = .015). Treatment-emergent adverse events occurring in ≥5% of patients in either vortioxetine arm and at least twice more frequently than placebo were nausea, headache, vomiting, and dizziness. Conclusion: Patients in all groups showed reduction in CDRS-R scores by end of study, with no difference between combined doses of vortioxetine and placebo. The primary endpoint was not met, thereby rendering the study negative. The overall favorable safety profile of vortioxetine in an adolescent patient population was consistent with that seen in adults. Clinical trial registration information: Active Reference (Fluoxetine) Fixed-Dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD); http://clinicaltrials.gov; NCT02709746.
2022
Inglese
Esperti anonimi
internazionale
scientifica
adolescents
antidepressants
clinical trial
major depressive disorder
treatment outcome
Findling, Robert L; Delbello, Melissa P; Zuddas, Alessandro; Emslie, Graham J; Ettrup, Anders; Petersen, Maria L; Schmidt, Simon N; Rosen, Monika
1.1 Articolo in rivista
info:eu-repo/semantics/article
1 Contributo su Rivista::1.1 Articolo in rivista
262
8
none
Files in This Item:
There are no files associated with this item.

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

Questionnaire and social

Share on:
Impostazioni cookie