H. Lundbeck A/S — Brintellix EMA EPAR variation assessment report (EMEA/H/C/002717, 2013)
H. Lundbeck A/S · 2013 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the assessment of pediatric studies for Brintellix (vortioxetine) in Major Depressive Disorder (MDD), submitted under Article 46 of Regulation (EC) No 1901/2006 (EMA/827117/2022). Study 12709A, a randomized, double-blind, placebo-controlled trial in children aged 7-11, did not show statistically significant efficacy for vortioxetine compared to placebo on the primary endpoint (CDRS-R total score change). Safety findings were consistent with previous adult and adolescent studies, with no new concerns identified.
Key findings — cited to the page
| Incidence of SAEs (vortioxetine 20mg) | 1.3 % | Study 12709A · p.12 |
| Incidence of SAEs (fluoxetine) | 1.2 % | Study 12709A · p.12 |
| TEAEs leading to withdrawal (placebo) | 0.7 % | Study 12709A · p.12 |
| TEAEs leading to withdrawal (vortioxetine 10mg) | 1.3 % | Study 12709A · p.12 |
| TEAEs leading to withdrawal (vortioxetine 20mg) | 2 % | Study 12709A · p.12 |
| Study type | interventional, randomized, double-blind, placebo-controlled, active-reference (fluoxetine), fixed-dose study | Study 12709A · p.3 |
| CDRS-R total score change from Randomization to Week 8 | -19.57 vs -17.48 placebo (difference -2.09) points | Study 12709A · p.11 |
| CDRS-R total score change from Randomization to Week 8 (interim analysis) | -22.78 vs -20.53 placebo (difference -2.26) points | Study 12709A · p.11 |
| CDRS-R total score change from Randomization to Week 8 (fluoxetine group) | -20.8 vs -17.48 placebo (difference -3.3) points | Study 12709A · p.11 |
| Incidence of TEAEs (vortioxetine 10mg) | 49 % | Study 12709A · p.12 |
| Incidence of TEAEs (vortioxetine 20mg) | 47 % | Study 12709A · p.12 |
| Incidence of TEAEs (fluoxetine) | 48 % | Study 12709A · p.12 |
Source: H. Lundbeck A/S ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →