Abstract
BackgroundMethylphenidate (MPH), the first choice medication for attention-deficit hyperactivity disorder (ADHD), is associated with serious adverse effects like arrhythmia. Evidence on the association of ADHD with immune and oxidant-antioxidant imbalances offers potential for antioxidant and/or immunomodulatory nutritional supplements as ADHD therapy. One small randomised trial in ADHD suggests, despite various limitations, therapeutic benefit from Pycnogenol®, a herbal, polyphenol-rich extract.MethodsThis phase III trial is a 10-week, randomised, double-blind, placebo and active treatment controlled multicentre trial with three parallel treatment arms to compare the effect of Pycnogenol® to MPH and placebo on the behaviour of 144 paediatric ADHD and attention-deficit disorder (ADD) patients. Evaluations of behaviour (measured by the ADHD-Rating Scale (primary endpoint) and the Social-emotional Questionnaire (SEQ)), immunity (plasma cytokine and antibody levels, white blood cell counts and faecal microbial composition), oxidative stress (erythrocyte glutathione, plasma lipid-soluble vitamins and malondialdehyde and urinary 8-OHdG levels, as well as antioxidant enzyme activity and gene expression), serum zinc and neuropeptide Y level, urinary catecholamines and physical complaints (Physical Complaints Questionnaire) will be performed in week 10 and compared to baseline. Acceptability evaluations will be based on adherence, dropouts and reports of adverse events. Dietary habits will be taken into account.DiscussionThis trial takes into account comorbid behavioural and physical symptoms, as well as a broad range of innovative immune and oxidative biomarkers, expected to provide fundamental knowledge on ADHD aetiology and therapy. Research on microbiota in ADHD is novel. Moreover, the active control arm is rather unseen in research on nutritional supplements, but of great importance, as patients and parents are often concerned with the side effects of MPH.Trial registrationClinicaltrials.gov number: NCT02700685. Registered on 18 January 2016. EudraCT 2016-000215-32. Registered on 4 October 2016.
Highlights
Methylphenidate (MPH), the first choice medication for attention-deficit hyperactivity disorder (ADHD), is associated with serious adverse effects like arrhythmia
Ceylan et al observed increased levels of adenosine deaminase, a marker of cellular immunity, and of the oxidative enzymes xanthine oxidase (XO) and nitric oxide synthase, and decreased levels of the antioxidant enzymes glutathione-S-transferase and paraoxonase-1. These results indicate the involvement of oxidative changes and cellular immunity in ADHD [9]
To evaluate the effect of Pycnogenol® on ADHD and attention-deficit disorder (ADD) behaviour and comorbid physical and psychiatric symptoms, as well as on immunity, oxidative damage, antioxidant status and neurochemical parameters, as compared to placebo and MPH treatment
Summary
Objective To evaluate the effect of Pycnogenol® on ADHD and ADD behaviour and comorbid physical and psychiatric symptoms, as well as on immunity, oxidative damage, antioxidant status and neurochemical parameters, as compared to placebo and MPH treatment. 2. As compared to placebo and MPH, Pycnogenol® increases antioxidant levels, reduces oxidative damage, improves immune and neurochemical status and reduces comorbid physical and psychiatric complaints. As compared to placebo and MPH, Pycnogenol® increases antioxidant levels, reduces oxidative damage, improves immune and neurochemical status and reduces comorbid physical and psychiatric complaints Design This is a phase III, randomised, double-blind, placebo and active product controlled, multicentre clinical trial with three parallel treatment arms to compare effects on ADHD and ADD behaviour between Pycnogenol®, MPH (Medikinet® Retard) and placebo, using the ADHDRating Scale (ADHD-RS) as a primary outcome measure. Guanethidine, seizure medicine, antidepressants, blood thinners, blood pressure, or diet medication 3 months before inclusion
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