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Vortioxetine for Major Depressive Disorder in Children: 12-Week Randomized, Placebo-Controlled Study
Michael Huss1, Robert L Findling2, Melissa P DelBello3
1University Medicine of Gutenberg University, Mainz, Germany.
Insights
This study found vortioxetine did not significantly improve major depressive disorder symptoms in children aged 7-11 compared to placebo. Safety and tolerability were comparable to adult data, with no major concerns identified.
Area of Science:
- Pediatric Psychiatry
- Pharmacology
- Clinical Trials
Background:
- Major Depressive Disorder (MDD) is a significant concern in pediatric populations.
- Limited treatment options exist for children with MDD, necessitating research into novel pharmacotherapies.
- Vortioxetine has shown efficacy in adult MDD, but its use in younger children requires investigation.
Purpose of the Study:
- To assess the efficacy, safety, and tolerability of vortioxetine in children aged 7 to 11 years diagnosed with MDD.
- To compare vortioxetine's effectiveness against placebo and fluoxetine in this pediatric population.
- To evaluate treatment-emergent adverse events associated with vortioxetine use in children.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted following a single-blind lead-in period.
- Patients with incomplete symptom improvement received brief psychosocial intervention plus placebo, vortioxetine (10 mg/day or 20 mg/day), or fluoxetine (20 mg/day).
- The primary endpoint was the change in Children's Depression Rating Scale-Revised (CDRS-R) total score from baseline to week 8.
Main Results:
- No statistically significant difference in CDRS-R score improvement was observed between vortioxetine (average of 10mg and 20mg doses) and placebo (p=0.0937).
- Enrollment to the fluoxetine arm was stopped early based on an interim analysis.
- Treatment-emergent adverse events were reported by 47% of patients, with nausea being most common in vortioxetine groups (11.1%-12.6%).
Conclusions:
- Vortioxetine did not demonstrate statistically significant efficacy in treating major depressive disorder in children aged 7-11 years.
- The safety and tolerability profile of vortioxetine in this pediatric cohort was consistent with findings in adolescents and adults.
- No significant safety concerns beyond those expected were identified during the study.
Objective:
To evaluate efficacy, safety, and tolerability of vortioxetine in children ages 7 to 11 years with major depressive disorder.
Method:
Patients meeting criteria for incomplete improvement in depressive symptoms (Children's Depression Rating Scale-Revised [CDRS-R] total score ≥40 plus <40% reduction and Parent Global Assessment Global Improvement score >2) after 4 weeks of single-blind lead-in treatment with a brief psychosocial intervention plus placebo were randomized 1:1:1:1 to 8-week double-blind treatment with brief psychosocial intervention and placebo, vortioxetine 10 mg/day, vortioxetine 20 mg/day, or fluoxetine 20 mg/day. Following preplanned interim analysis, enrollment to fluoxetine was stopped, and patients were randomized 1:1:1 to placebo, vortioxetine 10 mg, or vortioxetine 20 mg. The primary end point was change in CDRS-R total score from baseline to week 8 for average of vortioxetine 10-mg and 20-mg doses vs placebo.
Results:
Of 683 patients enrolled in single-blind lead-in treatment, 540 were randomized to the double-blind period. The mean (SE) change from randomization to week 8 in CDRS-R total score for average of vortioxetine 10-mg and 20-mg doses vs placebo was -19.6 (1.2) and -17.5 (1.4), with a mean difference of -2.1 (1.2) (2-sided p = .0937). Overall, 47% of patients reported treatment-emergent adverse events in the double-blind period; nausea was the most common adverse event in the vortioxetine groups (11.1%-12.6%).
Conclusion:
No statistically significant differences were observed in improvement in CDRS-R total score between placebo and vortioxetine; hence, efficacy of vortioxetine for treatment of major depressive disorder in children could not be confirmed. Safety and tolerability data were similar to that seen in adolescents and adults, with no outstanding safety concerns.
Clinical Trial Registration Information:
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD); https://clinicaltrials.gov/study/NCT02709655.
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