Effect of Pycnogenol® on ADHD

NCT ID: NCT02700685

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2020-11-20

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.

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Pycnogenol

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Placebo treatment (identical capsules containing excipients only)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo treatment (identical capsules containing excipients only)

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

Group Type: ACTIVE_COMPARATOR

Methylphenidate

Intervention Type: DRUG

Standard pharmaceutical treatment for ADHD, slow release.

Interventions

Pycnogenol

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

Intervention Type: DIETARY_SUPPLEMENT

Methylphenidate

Standard pharmaceutical treatment for ADHD, slow release.

Intervention Type: DRUG

Placebo

Placebo treatment (identical capsules containing excipients only)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nina Hermans

OTHER

Sponsor Role: lead

Responsible Party

Nina Hermans

Prof. Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nina Hermans, PhD

Role: STUDY_DIRECTOR

Universiteit Antwerpen

Locations

Universitaire Kinder- en Jeugdpsychiatrie

Borgerhout, , Belgium

University Hospital Antwerp

Edegem, , Belgium

University Hospital Ghent

Ghent, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 28351412 (View on PubMed)

Other Identifiers

Pycno 2015-14

Identifier Type: -

Identifier Source: org_study_id