How to (tr)eat?: A double-blind randomized controlled trial investigating broad-spectrum micronutrients in highly impulsive children and adolescents

Introduction:

Despite the popularity with consumers of using nutritional methods for the treatment of psychiatric illnesses, high quality evidence is missing. First studies assessing micronutrients for the treatment of impulsivity/ADHD have shown promising benefits. However, in the child/adolescent area, they have been mainly open- label, retrospective database analyses, case reports, or patient preference studies. Cross-disorder approaches and studies investigating long-term effects are missing. Thus, further research is required, in particular controlled studies with adolescents in larger samples.

Methods:

This two-centre study investigates the efficacy and safety of broad-spectrum micronutrients in n = 180 highly impulsive children and adolescents (10 – 18 years) with a high level of multi-dimensional impulsivity (based on the clinician-rated Clinical Global Impression – Severity [CGI-S] scale and the self-rated Affective Reactivity Index [ARI] score). The study design consists of a randomized double-blind placebo controlled phase (10 weeks) followed by an open label phase (10 weeks).

Results:

The primary outcome measure is the response rate at the end of the placebo-controlled phase. Response is defined as a CGI-Improvement score with a focus on impulsivity of 1 or 2 (= very much improved or much improved) plus a reduction in the self-rated ARI total score of at least 30% compared to baseline. Secondary outcome measures are changes in compulsivity, irritability, sleep problems, motor activity, ADHD symptoms, and aggression. Additionally, safety and tolerability of broad-spectrum micronutrients, treatment adherence, microbiome, epigenetics, blood biomarkers, physical activity and neurocognitive functioning will be assessed.

Conclusion:

To the authors' knowledge, this is the first randomized controlled trial to investigate broad-spectrum micronutrients as treatment of high-level multi-dimensional impulsivity in children and adolescents. Relevant aspects of study design and analysis will be presented and discussed in detail. Recruitment will commence in early 2019.

This study is part of the European Union (H2020) funded project Eat2beNICE (“Effects of Nutrition and Lifestyle on Impulsive, Compulsive, and Externalizing Behaviours”), which aims to identify nutrition and lifestyle drivers that can be employed to prevent detrimental impulsivity/compulsivity in males and females across the lifespan, characterize the etiologic paths leading to extreme behaviour, and promote policy changes to counteract maladaptive impulsivity/compulsivity by disseminating evidence-based information about health-related behaviours to families, clinicians, policy makers, and general public.