Effect of Pycnogenol® on ADHD

ADHD Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700685
• Other study ID #: Pycno 2015-14
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2017
• Est. completion date: November 20, 2020

Study information

• Verified date: April 2021
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 treatment for ADHD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: November 20, 2020
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD

Intervention

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

Drug:
• Methylphenidate
Standard pharmaceutical treatment for ADHD, slow release.

Other:
• Placebo
Placebo treatment (identical capsules containing excipients only)

Locations

Country	Name	City	State
Belgium	Universitaire Kinder- en Jeugdpsychiatrie	Borgerhout
Belgium	University Hospital Antwerp	Edegem
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
Nina Hermans

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summed ADHD score of the ADHD-Rating Scale as rated by teachers		10 weeks
Secondary	Summed ADHD score of the ADHD-Rating Scale as rated by teachers		5 weeks
Secondary	Summed ADHD score of the ADHD-Rating Scale as rated by parents		5 weeks, 10 weeks
Secondary	Summed ADHD score of the Social-Emotional Questionnaire (SEQ) as rated by parents and teachers		10 weeks
Secondary	Scores on ADHD subscales of the ADHD-RS as rated by parents and teachers - hyperactivity, impulsivity and inattention		5 & 10 weeks
Secondary	Scores on ADHD subscales of the SEQ as rated by parents and teachers - hyperactivity, impulsivity and inattention		5 & 10 weeks
Secondary	Percentage of responders (ADHD-RS) as rated by parents and teachers	Score reduction of at least 20% for parents and/or teachers	5 & 10 weeks
Secondary	Percentage of responders (SEQ) as rated by parents and teachers	Score reduction of at least 20% for parents and/or teachers	5 & 10 weeks
Secondary	Social behavior problems subscale of the SEQ, as rated by parents and teachers		10 weeks
Secondary	Anxiety subscale of the SEQ, as rated by parents and teachers		10 weeks
Secondary	Physical and sleep complaints score as measured by the Physical Complaints Questionnaire (PCQ)		5 & 10 weeks
Secondary	Erythrocyte glutathione (GSH) level		10 weeks
Secondary	Urinary 8-OHdG level		10 weeks
Secondary	Plasma cytokine levels		10 weeks
Secondary	Plasma antibody levels		10 weeks
Secondary	Gene expression		10 weeks
Secondary	Serum neuropeptide Y		10 weeks
Secondary	Serum zinc		10 weeks
Secondary	Intestinal microbial composition		10 weeks
Secondary	Intervention acceptability	Percentage of participants with side effects, treatment adherence and proportion of drop-outs	10 weeks
Secondary	Intervention acceptability	Percentage of participants with side effects	10 weeks
Secondary	Intervention acceptability	Proportion of drop-outs	10 weeks
Secondary	Intervention acceptability	Treatment adherence	10 weeks
Secondary	Urinary catecholamines		10 weeks
Secondary	Plasma lipid-soluble vitamins		10 weeks
Secondary	Long-term follow up	Long-term follow up on eventual treatment choice (medication, no intervention, nutritional supplement)	6 months
Secondary	Long-term follow up	Long-term follow up on behaviour	6 months
Secondary	Long-term follow up	Long-term follow up on physical/psychiatric complaints	6 months