12712B Cont. Ext. study of Vortioxetine in patients (7-17yrs) with MDD
Research type
Research Study
Full title
Long-term, open-label, flexible-dose, continuation extension study with vortioxetine in \nchild and adolescent patients with Major Depressive Disorder (MDD) from 7 to 17 years \nof age
IRAS ID
205741
Contact name
Ashish Kumar
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2015-002658-11
Duration of Study in the UK
2 years, 6 months, 17 days
Research summary
Mood disorders in children and adolescents are among the most debilitating illnesses, exerting a major impact on family and social functioning, school performance and an increased risk of recurrence, substance abuse, psychiatric comorbidity and suicidality. In May 2014, WHO’s Health for the world’s adolescents report reveals that depression is the predominant cause of illness and disability for both boys and girls aged 10 to 19 years and adds that the top 3 causes of adolescent deaths globally are road traffic injuries, HIV/AIDS, and suicide. Worldwide, an estimated 1.3 million adolescents died in 2012. The prevalence of Major depressive disorder (MDD) is estimated to be approximately 2% in children and 4 to 8% in adolescents.\n\nOnly one antidepressant, fluoxetine, is currently approved in Europe for the treatment of MDD in children and adolescents. The development of a new antidepressant will increase and strengthen the pharmacological treatment options for this patient population. This study is an extension study to study 12712A and the up to 2-year exposure is an EU requirement part of the agreed EMA Paediatric Investigational Plan (PIP) for vortioxetine (and the US PREA and BPCA) with the purpose to investigate the long-term safety and tolerability of vortioxetine in paediatric patients aged 7 -17 years. It is the expectation that this study will demonstrate a favourable safety and tolerability profile, and therefore a positive benefit-risk ratio for the use of vortioxetine in the paediatric population.\n\nApproximately 40 sites will take part in this study, and the study is expected to last for approximately 82 weeks. During the study a number of tests will be carried out to see if the study drug is working and help the understanding of MDD. These includes completion of questionnaires, blood and urine analyses, physical & neurological examination and ECG. \n
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0493
Date of REC Opinion
8 Jul 2016
REC opinion
Favourable Opinion