Micronutrients for ADHD in Youth (MADDY) Study: Comparison of Results from RCT and Open Label Extension
The study was funded through private donations to the Nutrition and Mental Health Research Fund, managed by the Foundation for Excellence in Mental Health Care (FEMHC), plus a direct grant from FEMHC, and from the Gratis Foundation. Financial support from the National Institutes of Health (NIH) National Center for Complementary and Integrative Health (NCCIH) R90AT008924 to the National University for Natural Medicine, NIH-NCCIH T32 AT002688 to Oregon Health & Science University (OHSU); the National Center for Advancing Translational Sciences of the NIH, UL1TR000128, UL1TR002369; UL1TR002733 at OHSU and Ohio State University; OHSU’s Department of Child and Adolescent Psychiatry; the Department of Behavioral Health and Psychiatry and the Research Institute at Nationwide Children’s Hospital, the Department of Psychiatry and Behavioral Health as well as the Department of Human Sciences at Ohio State University. In Canada, funding was received through the Nutrition and Mental Health Fund, administered by the Calgary Foundation.
European Child & Adolescent Psychiatry
Background The Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youth (MADDY) study evaluated the efficacy and safety of a multinutrient formula for children with ADHD and emotional dysregulation. The post-RCT open-label extension (OLE) compared the effect of treatment duration (8 weeks vs 16 weeks) on ADHD symptoms, height velocity, and adverse events (AEs).
Methods Children aged 6–12 years randomized to multinutrients vs. placebo for 8 weeks (RCT), received an 8–week OLE for a total of 16 weeks. Assessments included the Clinical Global Impression-Improvement (CGI-I), Child and Adolescent Symptom Inventory-5 (CASI-5), Pediatric Adverse Events Rating Scale (PAERS), and anthropometric measures (height and weight)
Results Of the 126 in the RCT, 103 (81%) continued in the OLE. For those initially assigned to placebo, CGI-I responders increased from 23% in the RCT to 64% in the OLE; those who took multinutrients for 16 weeks increased from 53% (RCT) to 66% responders (OLE). Both groups improved on the CASI-5 composite score and subscales from week 8 to week 16 (all p–values < 0.01). The group taking 16 weeks of multinutrients had marginally greater height growth (2.3 cm) than those with 8 weeks (1.8 cm) (p = 0.07). No difference in AEs between groups was found.
Conclusion The response rate to multinutrients by blinded clinician ratings at 8 weeks was maintained to 16 weeks; the response rate in the group initially assigned to placebo improved significantly with 8 weeks of multinutrients and almost caught up with 16 weeks. Longer time on multinutrients did not result in greater AEs, confirming an acceptable safety profile.
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Leung, B. M., Srikanth, P., Robinette, L., Bruton, A. M., Tost, G., Hatsu, I., ... & Johnstone, J. M. (2023). Micronutrients for ADHD in youth (MADDY) study: comparison of results from RCT and open label extension. European Child & Adolescent Psychiatry, 1-13.