Status: Funded - Open
Non-invasive vagus stimulation for resistant depression in youth – an experimental proof-of-concept
Julian Koenig, Dr sc hum, MA
BACKGROUND: Depression among adolescents is a major risk factor for suicide, which is one of the leading causes of death in this age group. Most importantly, about 40% of children and adolescents with depression do not benefit from the treatment options available (termed: treatment resistant depression).
GAP: Vagus nerve stimulation (VNS) is applied as treatment option for adults with treatment resistant depression with good effectiveness and safety. Transcutaneous VNS (tVNS) is also considered safe in the treatment of children and adolescents with epilepsy. Proof-of-concept studies showing that tVNS can alter depressive symptoms in children and adolescents with clinical depression are missing.
HYPOTHESIS: It is hypothesized that tVNS compared to sham stimulation improves difficulties in emotion processing and emotion regulation that are characteristic for depressed children and adolescents.
METHODS: The study utilizes a cross-over randomized, within-subject (sham vs. tVNS), controlled (depressed vs. healthy controls) experimental trial, including 30 adolescents (12-17 years of age) with clinical depression and 30 age- and sex-matched controls with no life-time history of depression.
IMPACT: Alternative treatment approaches for treatment resistant depression in children and adolescents are desperately needed. tVNS provides a unique opportunity to address a mental health problem of crucial prevalence. Taking the first step towards a proof-of-concept will lead the way to larger clinical randomized controlled trials on the efficiency and effectiveness of tVNS to alter depressive symptoms in youth.