A study to evaluate the long-term safety and tolerability of a product named vortioxetine (used in depression) in children and adolescents.

Phase 1

Conditions: Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
MedDRA version: 19.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders
Major Depressive Disorder

Registration Number: EUCTR2008-005356-25-FI

Lead Sponsor: H. Lundbeck A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 850

Inclusion Criteria

- The patient is a male or female child aged =7 and <12 years or an 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 850
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent patients with a<br>Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD.;Secondary Objective: Evaluation of the long-term effectiveness of flexible doses of vortioxetine in a range of 5 mg/day to 20 mg/day on:<br>- depressive symptoms<br>- clinical global impression<br>- cognitive function<br>- functionality<br>;Primary end point(s): Safety:<br>Safety evaluation based on adverse events, paediatric adverse event rating scale (PAERS), clinical safety laboratory tests (including reproductive hormones), vital signs, weight, height, Tanner score, menstrual cycle, ECG, and C-SSRS.;Timepoint(s) of evaluation of this end point: Throughout the study

Secondary Outcome Measures