12712A Extension study of vortioxetine in patients (7-18yrs) with MDD
Research type
Research Study
Full title
Long-term, open-label, flexible-dose, extension study of vortioxetine in child and adolescent patients with Major Depressive Disorder (MDD) from 7 to 18 years of age
IRAS ID
202787
Contact name
Ashish Kumar
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2008-005356-25
Duration of Study in the UK
2 years, 7 months, 29 days
Research summary
Summary of Research
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. Children and adolescents suffering from depression may be treated with a marketed antidepressant therapy or psychotherapy but not all patients respond sufficiently well to these therapies. This study is a phase 3 long-term, open-label, flexible-dose, extension study to evaluate the effectiveness, safety and tolerability of vortioxetine and to test whether it can help improve the symptoms of depression in children and adolescents.\n\nApproximately 850 participants will take part in this study. The study is being done at approximately 120 different research sites in about 20 countries. Sites involved must have taken part in the 12709A and 12710A, and it is expected to last for about 30 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. \nSummary of Results
In this 26-week extension study, flexible doses of vortioxetine were safe and well tolerated in children and adolescents with Major Depressive Disorder. The safety and tolerability profile of vortioxetine in the paediatric patients after long-term use was comparable to what has been oberved in paediatric patients after short-term use. No important risks were identified in the paediatric population beyond those established for the adult population.
Improvements in depressive symtptoms were observed and the majority of patients were in remission at the end of the study. Improvements in cognitive function and functionality were also observed.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0254
Date of REC Opinion
20 Jun 2016
REC opinion
Further Information Favourable Opinion