Effect of Pycnogenol® on attention-deficit hyperactivity disorder (ADHD): study protocol for a randomised controlled...

Area of Science:

• Pediatric neurology
• Nutritional science
• Psychiatry

Background:

• Methylphenidate (MPH), a first-line ADHD medication, carries risks like arrhythmia.
• ADHD is linked to immune and oxidant-antioxidant imbalances, suggesting nutritional supplements as a therapeutic avenue.
• Pycnogenol®, a polyphenol-rich herbal extract, has shown potential benefits in a small ADHD trial.

Purpose of the Study:

• To compare the efficacy of Pycnogenol® against methylphenidate (MPH) and placebo in pediatric ADHD and ADD patients.
• To evaluate the effects of Pycnogenol® on behavior, immunity, oxidative stress, and other biomarkers.
• To assess the safety and acceptability of Pycnogenol® as an ADHD therapy.

Main Methods:

• A 10-week, randomized, double-blind, placebo and active-controlled multicenter trial involving 144 pediatric ADHD/ADD patients.
• Three parallel treatment arms: Pycnogenol®, MPH, and placebo.
• Comprehensive assessments included behavioral scales (ADHD-Rating Scale, SEQ), immune markers, oxidative stress indicators, and physical complaints.

Main Results:

• The study is ongoing; results are pending.
• This trial will provide data on Pycnogenol®'s effects on ADHD symptoms and underlying biological mechanisms.
• Innovative biomarkers and microbiota analysis are included to deepen understanding of ADHD.

Conclusions:

• This trial is expected to offer fundamental insights into ADHD etiology and treatment.
• The inclusion of an active control arm (MPH) is crucial for comparing nutritional supplements to standard medication.
• Findings will inform the potential use of Pycnogenol® as a safer alternative for managing ADHD.