12710A Ph 3 study of vortioxetine in paed patients(12-17yrs) with MDD
Research type
Research Study
Full title
Interventional, randomised, double-blind, placebo-controlled, active reference (fluoxetine), fixed-dose study of vortioxetine in paediatric patients aged 12 to 17 years, with Major depressive disorder (MDD)
IRAS ID
197334
Contact name
Ashish Kumar
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2008-005354-20
Duration of Study in the UK
2 years, 3 months, 3 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. 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 randomised, double-blind, placebo-controlled, active reference fixed-dose 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 100 sites are planned in approximately 15 countries worldwide with patients from the European Union, Europe outside the European Union, North America, and other geographical regions. Approximately 1072 participants will be screened for participation in the study. It is expected that between 750 participants will be enrolled, and it is expected to last for up to 18 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/0233
Date of REC Opinion
31 May 2016
REC opinion
Further Information Favourable Opinion