Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years With Major Depressive Disorder (MDD)

Inclusion Criteria:

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

2. The patient has a CDRS-R total score ≥45 at the Screening Visit and the Baseline.

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

4. The patient is a boy or girl, aged ≥7 and <12 years at Screening Visit

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

Exclusion Criteria:

1. The patient has participated in a clinical study <30 days prior to the Screening
Visit.

2. The patient has previously participated in a study with vortioxetine.

Other protocol defined inclusion and exclusion criteria may apply