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

Inclusion Criteria:

• The patient is a male or female, aged ≥12 and ≤17 years at Screening (patients whoturn 18 years during the study will be allowed to continue in the study).

• The patient has Major depressive disorder (MDD), diagnosed according to DSM-5™.

• The patient has a Children Depression Rating Scale - Revised (CDRS-R) total score ≥45at the Screening Visit and at the Baseline.

• The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≥4 atthe Screening Visit and at the Baseline

• The patient has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.

Exclusion Criteria:

• The patient has participated in a clinical study <30 days prior to the ScreeningVisit. Other protocol defined inclusion and exclusion criteria may apply