Summary
Interventional, randomized, double-blind, placebo-controlled, active reference (fluoxetine), fixed-dose study of vortioxetine in patients aged 7 through 17 years, with Major depressive disorder (MDD)
Long-term, open-label, flexible-dose, extension study of vortioxetine in child and adolescent patients with Major Depressive Disorder (MDD) from 7 through 17 years of age.
Total # of Subjects Needed:
Approximately 750 subjects at 100 sites world wide.
Study Details
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. Only one antidepressant, fluoxetine, is currently approved in Europe for the treatment of MDD in children and adolescents. In the US only fluoxetine is approved for children and fluoxetine and escitalopram for the adolescent population. Development of a new antidepressant will increase and strengthen the pharmacological treatment options for this patient population. Signs and symptoms of MDD are similar to the adult population, but depressive disorders meeting the diagnostic criteria rarely is present before the age of seven years. The clinical picture may differ according to age at presentation. Children may have mood liability, irritability, low frustration tolerance, somatic complaints, and/or social withdrawal instead of verbalizing feelings of depression, whilst adolescents are more likely than children to complain of feelings of hopelessness/helplessness, lack of energy and to have a higher rate of suicidal thoughts. For this reason separate studies are to be conducted in children and adolescents.
The aim of this study is to evaluate the efficacy of the study medication 10 mg/day and 20 mg/day versus placebo after 8 weeks of treatment on depressive symptoms in children ages 7 through 17 years with a DSM-5™ diagnosis of MDD. Upon completion of the 8-weeks of study medication all subjects can roll over to an open-label portion of the study where all subjects will receive the active study medication up to 30 weeks (6-months).
Educational Videos
Major Depressive Disorder Video (1): HERE
Major Depressive Disorder Video (2): HERE
Major Depressive Disorder Video (3): HERE
If you would like to learn more about the different study opportunities you may call 1-800-530-0998 or for local callers please call 801-356-5555. To apply for this study, fill out the online application HERE.