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

• Status: Recruiting
• Trial end date: 2022-07-29
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Vortioxetine

Criteria

Inclusion Criteria:

• The patient 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 patient must have completed Study 12709A or 12710A (Visit 12, Completion Visit) immediately prior to enrolment into this extension study.

• The patient had a primary diagnosis of MDD at entry in study 12709A or 12710A, diagnosed according to DSM-5™.

• The patient is indicated for long-term treatment with vortioxetine according to the clinical opinion of the Investigator.

• For patients aged ≥7 and ≤17 years at the Baseline visit; the patient 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 patients who turned 18 years during the lead-in study 12710A; the patient has signed the Informed Consent Form.

Exclusion Criteria:

• The patient has been diagnosed with another psychiatric disorder (for example mania,bipolar disorder, schizophrenia or any psychotic disorder) during study 12709A or 12710A.

• 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