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 who
turn 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 CDRS-R total score ≥45 at the Screening Visit and at the Baseline.

- The patient has a CGI-S score ≥4 at the 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 Screening
Visit.

Other protocol defined inclusion and exclusion criteria may apply