Omega-3 fatty acids as a treatment for pediatric depression. A phase III, 36 weeks, multi-center, double-blind, placebo-controlled randomized superiority study.
Häberling et al. (2019) describes the dilemma that comes with depressive disorders in childhood and adolescence, including the poor treatment adherence and the concerns over the use of antidepressant drugs at such a young age (e.g., side effects). But depressive disorders represent the highest burden of disease in this age group. The aim of this trial was to investigate the safety and efficacy of omega-3 fatty acids in the early course of pediatric major depressive disorder (MDD). The sample consisted of 220 patients aged 8-17 years with major depressive disorder of at least moderate severity. The children and adolescents were randomized to either receive omega-3 fatty acids or placebo daily for 36 weeks. The primary outcomes measured were alterations in depression severity, and remission and recovery rates, while the participants’ omega-3 index and inflammatory parameters were measured as secondary outcomes. This trial was conducted to determine if omega-3 fatty acids play a role in the development of pediatric major depressive disorder. This study particularly focused on the clinically depressed with pre-existing omega-3 fatty acid deficiencies, elevated markers of oxidative stress, or signs of inflammation. [NPID: MDD, pediatric, omega-3, depression, trial]
Year: 2019