Effect of a polyphenol-rich plant extract on Attention-Deficit Hyperactivity Disorder (ADHD): a randomised, double blind, placebo and active product controlled multicenter trial.

Methylphenidate (MPH, e.g. Rilatine, Medikinet, Concerta), the first choice medication for Attention-Deficit Hyperactivity Disorder (ADHD), is associated with several adverse effects like insomnia and decreased appetite. In addition, ADHD has been associated with immune and oxidantantioxidant imbalances, which offer potential for certain nutritional supplements as ADHD therapy. A commercially available extract from Pinus pinaster, Pycnogenol®, has antioxidant and immunomodulatory activities. One small randomised trial suggests therapeutic benefit from Pycnogenol® in ADHD, though this study had several limitations. This project is therefore a randomised, double blind, parallel multicenter trial to compare the effect of Pycnogenol® to MPH and placebo over a ten week period on the behaviour of 144 ADHD and Attention-Deficit Disorder (ADD) patients. The ability of Pycnogenol® to improve ADHD or ADD behaviour will be evaluated in week 5 and 10. Evaluations of effects on immunity, oxidative stress and other psychiatric/physical complaints (to investigate mechanism of action) will be performed in week 10 as compared to baseline. Acceptability evaluations will be performed in week 10, based on adherence, dropouts and reports of adverse events. Dietary habits will be taken into account. Patients will be recruited from the university hospitals of Antwerp and Ghent, as well as ZNA Erasmus hospital (Antwerp).

Keywords:ADHD

Disciplines:Biomarker discovery and evaluation, Drug discovery and development, Medicinal products, Pharmaceutics, Pharmacognosy and phytochemistry, Pharmacology, Pharmacotherapy, Toxicology and toxinology, Other pharmaceutical sciences

Project type:Collaboration project