Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Participants With Major Depressive Disorder (MDD) From 7 to 18 Years of Age

Lundbeck

Status and phase: Terminated; Phase 3

Conditions: Depressive Disorder, Major

Treatments: Drug: Vortioxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02871297

2008-005356-25 (EudraCT Number)

12712A

Details and patient eligibility

About

Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent participants with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD.

Enrollment: 662 patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The participant is a male or female child aged ≥7 and <12 years or adolescent aged ≥12 and ≤18 years in the lead-in study (12709A and 12710A).
• The participant must have completed Study 12709A or 12710A (Visit 12, Completion Visit) immediately prior to enrolment into this extension study.
• The participant had a primary diagnosis of MDD at entry in study 12709A or 12710A, diagnosed according to DSM-5™.
• The participant is indicated for long-term treatment with vortioxetine according to the clinical opinion of the Investigator.
• For participants aged ≥7 and ≤17 years at the Baseline visit; the participant is able to understand the Informed Assent Form, and parent(s)/legal representative(s) are able to read and understand the Informed Consent Form.
• For participants who turned 18 years during the lead-in study 12710A; the participant has signed the Informed Consent Form.

Exclusion criteria

• The participant has been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12709A or 12710A.
• The participant has an attention-deficit/hyperactivity disorder (ADHD) that requires a pharmacological treatment other than a stimulant medication.

Other protocol-defined inclusion and exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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662 participants in 1 patient group

Vortioxetine

Experimental group

Description:

Vortioxetine tablets for 26 weeks. Single dose of vortioxetine oral drops (only a subset of participants).

Treatment:

Drug: Vortioxetine