Continuation With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age

Lundbeck

Status and phase: Completed; Phase 3

Conditions: Depressive Disorder, Major

Treatments: Drug: Vortioxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03108625

12712B

2015-002658-11 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 94 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient is a male or female child aged ≥7 and <12 years or an adolescent aged ≥12 and ≤17 years at Baseline in Study 12712B.
• The patient must have completed extension Study 12712A immediately prior to enrolment into this extension study.
• The patient had a primary diagnosis of a MDD at entry in Study 12709A or 12710A, diagnosed according to DSM-5™.
• The patient is still indicated for long-term treatment with vortioxetine according to the clinical opinion of the investigator.

Exclusion criteria

• The patient has been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12712A.
• The patient 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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94 participants in 1 patient group

Vortioxetine

Experimental group

Description:

Once daily dosing of vortioxetine (oral tablets) for 78 weeks.

Treatment:

Drug: Vortioxetine