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OpenTrials
Completed

NCT Number: NCT02700685

Effect of Pycnogenol® on ADHD

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitaire Kinder- en Jeugdpsychiatrie, Borgerhout, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pycnogenol

Dietary Supplement

Dietary supplement, standardised extract of French maritime Pine bark. This group receives a nutritional supplement for a period of 10 weeks.

Methylphenidate

Drug

Standard pharmaceutical treatment for ADHD, slow release.

Placebo

Other

Placebo treatment (identical capsules containing excipients only)

Primary outcomes

  1. Summed ADHD score of the ADHD-Rating Scale as rated by teachers

    Time frame: 10 weeks

Secondary outcomes

  1. Summed ADHD score of the ADHD-Rating Scale as rated by teachers

    Time frame: 5 weeks

  2. Summed ADHD score of the ADHD-Rating Scale as rated by parents

    Time frame: 5 weeks, 10 weeks

  3. Summed ADHD score of the Social-Emotional Questionnaire (SEQ) as rated by parents and teachers

    Time frame: 10 weeks

  4. Scores on ADHD subscales of the ADHD-RS as rated by parents and teachers - hyperactivity, impulsivity and inattention

    Time frame: 5 & 10 weeks

  5. Scores on ADHD subscales of the SEQ as rated by parents and teachers - hyperactivity, impulsivity and inattention

    Time frame: 5 & 10 weeks

  6. Percentage of responders (ADHD-RS) as rated by parents and teachers

    Time frame: 5 & 10 weeks

    Score reduction of at least 20% for parents and/or teachers

  7. Percentage of responders (SEQ) as rated by parents and teachers

    Time frame: 5 & 10 weeks

    Score reduction of at least 20% for parents and/or teachers

  8. Social behavior problems subscale of the SEQ, as rated by parents and teachers

    Time frame: 10 weeks

  9. Anxiety subscale of the SEQ, as rated by parents and teachers

    Time frame: 10 weeks

  10. Physical and sleep complaints score as measured by the Physical Complaints Questionnaire (PCQ)

    Time frame: 5 & 10 weeks

  11. Erythrocyte glutathione (GSH) level

    Time frame: 10 weeks

  12. Urinary 8-OHdG level

    Time frame: 10 weeks

  13. Plasma cytokine levels

    Time frame: 10 weeks

  14. Plasma antibody levels

    Time frame: 10 weeks

  15. Gene expression

    Time frame: 10 weeks

  16. Serum neuropeptide Y

    Time frame: 10 weeks

  17. Serum zinc

    Time frame: 10 weeks

  18. Intestinal microbial composition

    Time frame: 10 weeks

  19. Intervention acceptability

    Time frame: 10 weeks

    Percentage of participants with side effects, treatment adherence and proportion of drop-outs

  20. Intervention acceptability

    Time frame: 10 weeks

    Percentage of participants with side effects

  21. Intervention acceptability

    Time frame: 10 weeks

    Proportion of drop-outs

  22. Intervention acceptability

    Time frame: 10 weeks

    Treatment adherence

  23. Urinary catecholamines

    Time frame: 10 weeks

  24. Plasma lipid-soluble vitamins

    Time frame: 10 weeks

  25. Long-term follow up

    Time frame: 6 months

    Long-term follow up on eventual treatment choice (medication, no intervention, nutritional supplement)

  26. Long-term follow up

    Time frame: 6 months

    Long-term follow up on behaviour

  27. Long-term follow up

    Time frame: 6 months

    Long-term follow up on physical/psychiatric complaints

Sponsors and collaborators

Lead sponsor

Nina Hermans

Other

Registry information

Official study title

Effect of a Polyphenol-rich Plant Extract on Attention-Deficit Hyperactivity Disorder (ADHD): A Randomized, Double Blind, Placebo and Active Product Controlled Multicenter Trial.

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 7, 2016
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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