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ADHDPhase 3NCT02700685

Effect of Pycnogenol® on ADHD

A Phase 3 study testing Pycnogenol and Methylphenidate in people with ADHD, run by Nina Hermans at 3 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
ADHD
What is being tested?
Pycnogenol and Methylphenidate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
3 sitesBelgium
Study dates
1 Sep 2017to 20 Nov 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites

  • Universitaire Kinder- en Jeugdpsychiatrie

    Borgerhout

  • University Hospital Antwerp

    Edegem, 2650

  • University Hospital Ghent

    Ghent, 9000

Other trials in Belgium

About this study

Official 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.

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.

Conditions
ADHD
Being tested
Pycnogenol, Methylphenidate, Placebo
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PycnogenolDietary supplement

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

  • MethylphenidateDrug

    Standard pharmaceutical treatment for ADHD, slow release.

  • PlaceboOther

    Placebo treatment (identical capsules containing excipients only)

Study groups in NCT02700685
Study groupRoleWhat they receive
PycnogenolExperimentalDietary 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
Receives: Dietary Supplement: Pycnogenol
PlaceboPlacebo comparatorPlacebo treatment (identical capsules containing excipients only)
Receives: Other: Placebo
MethylphenidateActive comparatorStandard 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
Receives: Drug: Methylphenidate

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 10 weeks

Secondary outcomes (27)

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

    Measured: 5 weeks

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

    Measured: 5 weeks, 10 weeks

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

    Measured: 10 weeks

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

    Measured: 5 & 10 weeks

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

    Measured: 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

    Measured: 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

    Measured: 5 & 10 weeks

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

    Measured: 10 weeks

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

    Measured: 10 weeks

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

    Measured: 5 & 10 weeks

  11. Erythrocyte glutathione (GSH) level

    Measured: 10 weeks

  12. Urinary 8-OHdG level

    Measured: 10 weeks

  13. Plasma cytokine levels

    Measured: 10 weeks

  14. Plasma antibody levels

    Measured: 10 weeks

  15. Gene expression

    Measured: 10 weeks

  16. Serum neuropeptide Y

    Measured: 10 weeks

  17. Serum zinc

    Measured: 10 weeks

  18. Intestinal microbial composition

    Measured: 10 weeks

  19. Intervention acceptability

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

    Measured: 10 weeks

  20. Intervention acceptability

    Percentage of participants with side effects

    Measured: 10 weeks

  21. Intervention acceptability

    Proportion of drop-outs

    Measured: 10 weeks

  22. Intervention acceptability

    Treatment adherence

    Measured: 10 weeks

  23. Urinary catecholamines

    Measured: 10 weeks

  24. Plasma lipid-soluble vitamins

    Measured: 10 weeks

  25. Long-term follow up

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

    Measured: 6 months

  26. Long-term follow up

    Long-term follow up on behaviour

    Measured: 6 months

  27. Long-term follow up

    Long-term follow up on physical/psychiatric complaints

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2016 (estimated)
  2. Study start1 Sep 2017
  3. Primary completion20 Nov 2020
  4. Study completion20 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02700685
Sponsor's protocol ID
Pycno 2015-14
Status last verified
Apr 2021
First submitted
18 Jan 2016
Last updated
28 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pycnogenol and Methylphenidate in people with ADHD, run by Nina Hermans at 3 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Summed ADHD score of the ADHD-Rating Scale as rated by teachers (time frame: 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02700685, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021; AzTrials last refreshed its copy on 30 Oct 2026.

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