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CompletedNCT02700685Updated Apr 28, 2021

Effect of Pycnogenol® on ADHD

A Phase 3 interventional study of Pycnogenol and Methylphenidate in ADHD, sponsored by Nina Hermans. Completed at 3 sites in Belgium. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2021-04-28.

Sponsored by Nina Hermans · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • ADHD
03

In context

Lead sponsor

Nina Hermans is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    Pycnogenol

    Dietary supplement, standardised extract of French maritime Pine bark. This group receives a nutritional supplement for a period of 10 weeks. Subjects \< 30 kg body weight: 20 mg Pycnogenol/day Subjects \>= 30 kg body weight: 40 mg Pycnogenol/day

    Dietary Supplement: Pycnogenol

  • Placebo comparator
    Placebo

    Placebo treatment (identical capsules containing excipients only)

    Other: Placebo

  • Active comparator
    Methylphenidate

    Standard pharmaceutical treatment for ADHD, slow release. Subjects \< 30 kg body weight: 20 mg methylphenidate once per day Subjects \>= 30 kg body weight: 30 mg methylphenidate once per day

    Drug: Methylphenidate

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)

06

What researchers measure

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

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

    Time frame: 5 & 10 weeks

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

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

    Time frame: 5 & 10 weeks

  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

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

    Time frame: 10 weeks

  20. Intervention acceptability

    Percentage of participants with side effects

    Time frame: 10 weeks

  21. Intervention acceptability

    Proportion of drop-outs

    Time frame: 10 weeks

  22. Intervention acceptability

    Treatment adherence

    Time frame: 10 weeks

  23. Urinary catecholamines

    Time frame: 10 weeks

  24. Plasma lipid-soluble vitamins

    Time frame: 10 weeks

  25. Long-term follow up

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

    Time frame: 6 months

  26. Long-term follow up

    Long-term follow up on behaviour

    Time frame: 6 months

  27. Long-term follow up

    Long-term follow up on physical/psychiatric complaints

    Time frame: 6 months

07

Study locations

3 sites
  • Universitaire Kinder- en Jeugdpsychiatrie
    Borgerhout, Belgium
  • University Hospital Antwerp
    Edegem, 2650, Belgium
  • University Hospital Ghent
    Ghent, 9000, Belgium
08

References and documents

Publications

  • Verlaet AA, Ceulemans B, Verhelst H, Van West D, De Bruyne T, Pieters L, Savelkoul HF, Hermans N. Effect of Pycnogenol(R) on attention-deficit hyperactivity disorder (ADHD): study protocol for a randomised controlled trial. Trials. 2017 Mar 28;18(1):145. doi: 10.1186/s13063-017-1879-6. PubMed 28351412 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02700685
Lead sponsor
Nina Hermans
Responsible party
Nina Hermans (Prof. Dr., Universiteit Antwerpen) — Sponsor-investigator
First posted
Mar 7, 2016
Start date
Sep 1, 2017
Primary completion
Nov 20, 2020
Completion
Nov 20, 2020
Last update
Apr 28, 2021

Study contacts

Nina Hermans, PhD
study director · Universiteit Antwerpen

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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