Continuation With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age
- Registration Number
- NCT03108625
- Lead Sponsor
- H. Lundbeck A/S
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 94
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vortioxetine Vortioxetine Once daily dosing of vortioxetine (oral tablets) for 78 weeks.
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events (Safety) Up to Week 104 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
- Secondary Outcome Measures
Name Time Method Change in CDRS-R total score Change from study 12712A baseline to Week 104 Children Depression Rating Scale, revised version
Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration) Up to Week 104 Number of relapses (CDRS-R ≥40 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 Loss of remission (CDRS-R \<28 with a history of 2 weeks of clinical deterioration)
Change in CGI-S score Change from study 12712A baseline to Week 104 Clinical Global Impression - Severity of Illness
CGI-I score Week 104 Clinical Global Impression - Global Improvement
Children (7-11 years): change in BRIEF using the Global Executive Composite score Change from study 12712A baseline to Week 104 Behaviour Rating Inventory of Executive Function
Children (7-11 years): change in BRIEF using the Megacognition Index Change from study 12712A baseline to Week 104 Behaviour Rating Inventory of Executive Function
Adolescents (12-17 years): change in BRIEF-SR using the Global Executive Composite score Change from study 12712A baseline to Week 104 Behaviour Rating Inventory of Executive Function, Self-report version
Adolescents (12-17 years): change in BRIEF-SR using the Megacognition Index Change from study 12712A baseline to Week 104 Behaviour Rating Inventory of Executive Function, Self-report version
Change in CGAS score Change from study 12712A baseline to Week 104 Children's Global Assessment Scale
Change in PedsQL VAS score Change from study 12712A baseline to Week 104 Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales
Trial Locations
- Locations (31)
Centrum Badan Klinicznych PI-House Sp. z o.o.
🇵🇱Gdańsk, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej (SPZOZ) - Centrum Neuropsychiatrii "NEUROMED"
🇵🇱Wrocław, Poland
Clinic of Neurology and Psychiatry for Children and Adolescents
🇷🇸Belgrade, Serbia
Clinical Center of Vojvodina - Clinic of Psychiatry
🇷🇸Novi Sad, Serbia
Medicorehabilitation Research Center "Phoenix"
🇷🇺Rostov-on-Don, Russian Federation
Prywatne Gabinety Lekarskie ¿Promedicus¿ Anna Agnieszka Tomczak
🇵🇱Białystok, Poland
SPECTRUM Centrum Neurologii i Psychiatrii
🇵🇱Lublin, Poland
Universita degli Studi di Messina - Facolta di Medicina e Chirurgia
🇮🇹Messina, Italy
Guz "Saratov Regional Psychiatric Hospital St. Sofii"
🇷🇺Saratov, Russian Federation
State Budgetary Healthcare Institution of Sverdlovsk Region
🇷🇺Ekaterinburg, Russian Federation
Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo
🇪🇸Torremolinos, Spain
MHAT "Targovishte" AD
🇧🇬Targovishte, Bulgaria
CHU de Nantes - Hopital Hotel Dieu
🇫🇷Nantes, France
Nizhny Novgorod Region State Institution Of Healthcare
🇷🇺Nizhny Novgorod, Russian Federation
Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
🇷🇺Rostov-on-Don, Russian Federation
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
🇭🇺Gyula, Hungary
Marienthal Center of Psychiatry and Psychology
🇪🇪Tallinn, Estonia
DCC Mladost-M
🇧🇬Varna, Bulgaria
Linda Keruze's Psychiatric Center, LLC
🇱🇻Liepāja, Latvia
Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri
🇩🇪Mainz, Germany
Lipetsk Regional Psychoneurological Hospital
🇷🇺Lipetsk, Russian Federation
Filip Rybakowski Specjalistyczna Praktyka Lekarska
🇵🇱Poznań, Poland
Specialized Clinical Psychiatric Hospital 1 of the Ministry of Health
🇷🇺Krasnodar, Russian Federation
Cape Trial Centre
🇿🇦Bellville, South Africa
Alder Hey Childrens Hospital
🇬🇧Liverpool, United Kingdom
Scientific Institute Fondazione Stella Maris
🇮🇹Calambrone, Italy
State Budgetary Healthcare Institution
🇷🇺Tonnel'nyy, Russian Federation
Saratov State Medical University
🇷🇺Saratov, Russian Federation
Vadaskert Alapitvany
🇭🇺Budapest, Hungary
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Przychodnia Syntonia Poradnia Zdrowia Psychicznego
🇵🇱Kielce, Poland