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

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

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

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: Vortioxetine

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Targovishte, Bulgaria
    • MHAT "Targovishte" AD
  • Varna, Bulgaria
    • DCC Mladost-M
• Estonia
  • Tallinn, Estonia
    • Marienthal Center of Psychiatry and Psychology
• France
  • Nantes, France
    • CHU de Nantes - Hôpital Hôtel Dieu
• Germany
  • Mainz, Germany
    • Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri
• Hungary
  • Budapest, Hungary
    • Vadaskert Alapitvany
  • Gyula, Hungary
    • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
• Italy
  • Calambrone, Italy
    • Scientific Institute Fondazione Stella Maris
  • Messina, Italy
    • Universita degli Studi di Messina - Facolta di Medicina e Chirurgia
• Latvia
  • Liepāja, Latvia
    • Linda Keruze's Psychiatric Center, LLC
• Poland
  • Białystok, Poland
    • Prywatne Gabinety Lekarskie ¿Promedicus¿ Anna Agnieszka Tomczak
  • Gdańsk, Poland
    • Centrum Badan Klinicznych PI-House sp. z o.o.
  • Kielce, Poland
    • Przychodnia Syntonia Poradnia Zdrowia Psychicznego
  • Lublin, Poland
    • SPECTRUM Centrum Neurologii i Psychiatrii
  • Poznań, Poland
    • Filip Rybakowski Specjalistyczna Praktyka Lekarska
  • Wrocław, Poland
    • Samodzielny Publiczny Zaklad Opieki Zdrowotnej (SPZOZ) - Centrum Neuropsychiatrii "NEUROMED"
• Russian Federation
  • Ekaterinburg, Russian Federation
    • State Budgetary Healthcare Institution of Sverdlovsk Region
  • Krasnodar, Russian Federation
    • Specialized Clinical Psychiatric Hospital 1 of the Ministry of Health
  • Lipetsk, Russian Federation
    • Lipetsk regional psychoneurological hospital
  • Nizhny Novgorod, Russian Federation
    • Nizhny Novgorod Region State Institution Of Healthcare
  • Rostov-on-Don, Russian Federation
    • Medicorehabilitation Research Center "Phoenix"
  • Rostov-on-Don, Russian Federation
    • Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
  • Saratov, Russian Federation
    • Saratov State Medical University
  • Saratov, Russian Federation
    • Guz "Saratov Regional Psychiatric Hospital St. Sofii"
  • Tonnel'nyy, Russian Federation
    • State Budgetary Healthcare Institution
• Serbia
  • Belgrade, Serbia
    • Clinic of Neurology and Psychiatry for Children and Adolescents
  • Novi Sad, Serbia
    • Clinical Center of Vojvodina - Clinic of Psychiatry
• South Africa
  • Bellville, South Africa
    • Cape Trial Centre
• Spain
  • Madrid, Spain
    • Hospital General Universitario Gregorio Maranon
  • Torremolinos, Spain
    • Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo
• United Kingdom
  • Liverpool, United Kingdom
    • Alder Hey Childrens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): April 16, 2020
• Study Completion (Actual): April 16, 2020

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): June 24, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: adolescent; children
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin 5-HT3 Receptor Antagonists; Vortioxetine
• Other Study ID Numbers: 12712B; 2015-002658-11 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No