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

Lundbeck

Status and phase: Completed; Phase 3

Conditions: Depressive Disorder, Major

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02709746

2008-005354-20 (EudraCT Number)

12710A

Details and patient eligibility

About

Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) diagnosis of Major depressive disorder (MDD).

Enrollment: 784 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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784 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

Treatment:

Drug: Fluoxetine 20 mg/day

Placebo

Placebo Comparator group

Treatment:

Other: Placebo