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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Target dose is 10 mg/day; the dose can be down- or uptitrated to 5, 15, or 20 mg/day.
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
Time frame: Up to Week 104
Change in CDRS-R total score
Children Depression Rating Scale, revised version
Time frame: 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)
Time frame: 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)
Time frame: Up to Week 104
Change in CGI-S score
Clinical Global Impression - Severity of Illness
Time frame: Change from study 12712A baseline to Week 104
CGI-I score
Clinical Global Impression - Global Improvement
Time frame: Week 104
Children (7-11 years): change in BRIEF using the Global Executive Composite score
Behaviour Rating Inventory of Executive Function
Time frame: Change from study 12712A baseline to Week 104
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MHAT "Targovishte" AD
Targovishte, Bulgaria
DCC Mladost-M
Varna, Bulgaria
Marienthal Center of Psychiatry and Psychology
Tallinn, Estonia
CHU de Nantes - Hopital Hotel Dieu
Nantes, France
Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri
Mainz, Germany
Vadaskert Alapitvany
Budapest, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
Gyula, Hungary
Scientific Institute Fondazione Stella Maris
Calambrone, Italy
Universita degli Studi di Messina - Facolta di Medicina e Chirurgia
Messina, Italy
Linda Keruze's Psychiatric Center, LLC
Liepāja, Latvia
...and 21 more locations
Children (7-11 years): change in BRIEF using the Megacognition Index
Behaviour Rating Inventory of Executive Function
Time frame: 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
Time frame: 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
Time frame: Change from study 12712A baseline to Week 104
Change in CGAS score
Children's Global Assessment Scale
Time frame: Change from study 12712A baseline to Week 104
Change in PedsQL VAS score
Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales
Time frame: Change from study 12712A baseline to Week 104