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

Study Overview
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Brief Summary
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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

Official Title
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Long-term, Open-label, Flexible-dose, Continuation Extension Study With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Drug: Vortioxetine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vortioxetine<br>Once daily dosing of vortioxetine (oral tablets) for 78 weeks. | Drug: Vortioxetine<br>* Target dose is 10 mg/day; the dose can be down- or uptitrated to 5, 15, or 20 mg/day.<br>* Other names: Lu AA21004;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events (Safety) | Based on safety assessments (e.g. 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 | Up to Week 104 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CDRS-R total score | Children Depression Rating Scale, revised version | Change from study 12712A baseline to Week 104 | 
| Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration) | Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration) | Up to Week 104 | 
| Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration) | Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration) | Up to Week 104 | 
| Change in CGI-S score | Clinical Global Impression - Severity of Illness | Change from study 12712A baseline to Week 104 | 
| CGI-I score | Clinical Global Impression - Global Improvement | Week 104 | 
| Children (7-11 years): change in BRIEF using the Global Executive Composite score | Behaviour Rating Inventory of Executive Function | Change from study 12712A baseline to Week 104 | 
| Children (7-11 years): change in BRIEF using the Megacognition Index | Behaviour Rating Inventory of Executive Function | Change from study 12712A baseline to Week 104 | 
| Adolescents (12-17 years): change in BRIEF-SR using the Global Executive Composite score | Behaviour Rating Inventory of Executive Function, Self-report version | Change from study 12712A baseline to Week 104 | 
| Adolescents (12-17 years): change in BRIEF-SR using the Megacognition Index | Behaviour Rating Inventory of Executive Function, Self-report version | Change from study 12712A baseline to Week 104 | 
| Change in CGAS score | Children's Global Assessment Scale | Change from study 12712A baseline to Week 104 | 
| Change in PedsQL VAS score | Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales | Change from study 12712A baseline to Week 104 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, adolescent