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

Lundbeck

Status and phase: Completed; Phase 3

Conditions: Depressive Disorder, Major

Treatments: Other: Placebo; Drug: Fluoxetine 20mg/day; Drug: Vortioxetine 10 mg/day; Drug: Vortioxetine 20 mg/day

Study type: Interventional

Funder types: Industry

Identifiers

NCT02709655

2008-005353-38 (EudraCT Number)

12709A

Details and patient eligibility

About

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

Enrollment: 683 patients

Sex: All

Ages: 7 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The participant has MDD, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5™).
2. The participant has a CDRS-R total score ≥45 at the Screening Visit and the Baseline.
3. The participant has a CGI-S score ≥4 at the Screening Visit and the Baseline.
4. The participant is a boy or girl, aged ≥7 and <12 years at Screening Visit
5. The participant has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.

Exclusion criteria

1. The participant has participated in a clinical study <30 days prior to the Screening Visit.
2. The participant has previously participated in a study with vortioxetine.

Other protocol defined inclusion and exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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683 participants in 4 patient groups, including a placebo group

Vortioxetine 10 mg/day

Experimental group

Treatment:

Drug: Vortioxetine 10 mg/day

Vortioxetine 20 mg/day

Experimental group

Treatment:

Drug: Vortioxetine 20 mg/day

Fluoxetine 20 mg/day,

Active Comparator group

Description:

A decision has been taken to stop recruitment into this treatment arm.

Treatment:

Drug: Fluoxetine 20mg/day

Placebo

Placebo Comparator group

Treatment:

Other: Placebo