Effect of Pycnogenol® on ADHD

NCT02700685 | Completed Phase 3

• 1 other identifier: Pycno 2015-14
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

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

  10 weeks

Secondary Outcomes (27)

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

  5 weeks

• 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

Study Arms (3)

Pycnogenol

EXPERIMENTAL

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

PLACEBO COMPARATOR

Placebo treatment (identical capsules containing excipients only)

Other: Placebo

Methylphenidate

ACTIVE COMPARATOR

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

Pycnogenol DIETARY_SUPPLEMENT

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

Pycnogenol

Methylphenidate DRUG

Standard pharmaceutical treatment for ADHD, slow release.

Methylphenidate

Placebo OTHER

Placebo treatment (identical capsules containing excipients only)

Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nina Hermans: lead

Study Sites (3)

Universitaire Kinder- en Jeugdpsychiatrie

Borgerhout, Belgium

Location

University Hospital Antwerp

Edegem, 2650, Belgium

Location

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 28351412 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

pycnogenols; Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nina Hermans, PhD

  Universiteit Antwerpen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: March 7, 2016
• Study Start: September 1, 2017
• Primary Completion: November 20, 2020
• Study Completion: November 20, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

BE (3)