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

• Status: Recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

Summary

Investigation of the efficacy and safety of a new potential treatment of Major depressive disorder (MDD) in paediatric patients (age 7 to 11 years)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Collaborator: Takeda
• Treatments: Fluoxetine; Vortioxetine

Criteria

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