ADHD
Conditions
Brief summary
This double blind, randomised controlled trial examines the effect of a commercially available nutritional supplement on behaviour of ADHD patients, as well as on their physical and psychiatric co-morbidities, and level of oxidative stress and immune activity, as compared to placebo and standard pharmaceutical treatment for ADHD.
Interventions
DIETARY_SUPPLEMENTPycnogenol
Dietary supplement, standardised extract of French maritime Pine bark. This group receives a nutritional supplement for a period of 10 weeks.
DRUGMethylphenidate
Standard pharmaceutical treatment for ADHD, slow release.
OTHERPlacebo
Placebo treatment (identical capsules containing excipients only)
Sponsors
Nina Hermans
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* The patient is between 6-12 years old (both inclusive). * The patient satisfies the DSM-IV criteria for ADHD or ADD. * The patient has a responsible caregiver who is able to provide information about the patient's functional status. * Written informed consent is obtained from the patient and the legally accepted representative.
Exclusion criteria
* The patient does satisfy the DSM-IV for autism spectrum disorder. * The patient does have situational hyperactivity, pervasive developmental disorders, schizophrenia, other psychotic disorders such as mood or anxiety disorder, personality disorder as unsocial behaviour, personality change due to a general medical condition, mental retardation (IQ \< 70), understimulating environments, conduct disorder, chorea and other dyskinesias. The patient does not have tics or Tourette's syndrome, or personal or family history of psychotic disorder, bipolar illness, depression, or suicide attempt. * The patient does have any chronic medical disorder (diabetes, epilepsy or other seizure disorder, autoimmune disorder, gastrointestinal disorder, renal or cardiovascular disorders, etc.) or acute inflammatory disease. The patient does not have glaucoma, heart disease, heart rhythm disorder, high blood pressure, or peripheral vascular disease such as Raynaud's syndrome. * The patient did use any of these medications during the 3 months before entering the study: clonidine, guanethidine, blood thinners (e.g. warfarin or Coumadin), antidepressants (e.g. amitriptyline, citalopram, doxepin, fluoxetine, nortriptyline, paroxetine, sertraline), cold or allergy medicine that contains a decongestant, medications to treat high or low blood pressure, seizure medicine (e.g. phenobarbital, phenytoin, primidone), or diet pills. * The patient did take MAO inhibitor (isocarboxazid, linezolid, phenelzine, rasagiline, selegiline or tranylcypromine) in the past 14 days. * The patient has any other contraindication for the use of methylphenidate. * The patient did use vitamin/mineral/herbal/omega-3 supplements or other any medication (psychoactive medication, antibiotics, anti-inflammatory drugs, melatonin, etc.) \> 1 week during the 3 months before inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Summed ADHD score of the ADHD-Rating Scale as rated by teachers | 10 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Summed ADHD score of the ADHD-Rating Scale as rated by parents | 5 weeks, 10 weeks | — |
| Summed ADHD score of the Social-Emotional Questionnaire (SEQ) as rated by parents and teachers | 10 weeks | — |
| Scores on ADHD subscales of the ADHD-RS as rated by parents and teachers - hyperactivity, impulsivity and inattention | 5 & 10 weeks | — |
| Scores on ADHD subscales of the SEQ as rated by parents and teachers - hyperactivity, impulsivity and inattention | 5 & 10 weeks | — |
| Percentage of responders (ADHD-RS) as rated by parents and teachers | 5 & 10 weeks | Score reduction of at least 20% for parents and/or teachers |
| Percentage of responders (SEQ) as rated by parents and teachers | 5 & 10 weeks | Score reduction of at least 20% for parents and/or teachers |
| Social behavior problems subscale of the SEQ, as rated by parents and teachers | 10 weeks | — |
| Anxiety subscale of the SEQ, as rated by parents and teachers | 10 weeks | — |
| Physical and sleep complaints score as measured by the Physical Complaints Questionnaire (PCQ) | 5 & 10 weeks | — |
| Erythrocyte glutathione (GSH) level | 10 weeks | — |
| Summed ADHD score of the ADHD-Rating Scale as rated by teachers | 5 weeks | — |
| Plasma cytokine levels | 10 weeks | — |
| Plasma antibody levels | 10 weeks | — |
| Gene expression | 10 weeks | — |
| Serum neuropeptide Y | 10 weeks | — |
| Serum zinc | 10 weeks | — |
| Intestinal microbial composition | 10 weeks | — |
| Intervention acceptability | 10 weeks | Percentage of participants with side effects, treatment adherence and proportion of drop-outs |
| Urinary catecholamines | 10 weeks | — |
| Plasma lipid-soluble vitamins | 10 weeks | — |
| Long-term follow up | 6 months | Long-term follow up on eventual treatment choice (medication, no intervention, nutritional supplement) |
| Urinary 8-OHdG level | 10 weeks | — |
Countries
Belgium
Outcome results
None listed