Clinical trial NCT02700685: Effect of Pycnogenol® on ADHD
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ADHD
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 88
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Summed ADHD score of the ADHD-Rating Scale as rated by teachers
timeFrame: 10 weeks
Secondary outcomes:
measure: Summed ADHD score of the ADHD-Rating Scale as rated by teachers
timeFrame: 5 weeks
measure: Summed ADHD score of the ADHD-Rating Scale as rated by parents
timeFrame: 5 weeks, 10 weeks
measure: Summed ADHD score of the Social-Emotional Questionnaire (SEQ) as rated by parents and teachers
timeFrame: 10 weeks
measure: Scores on ADHD subscales of the ADHD-RS as rated by parents and teachers - hyperactivity, impulsivity and inattention
timeFrame: 5 & 10 weeks
measure: Scores on ADHD subscales of the SEQ as rated by parents and teachers - hyperactivity, impulsivity and inattention
timeFrame: 5 & 10 weeks
measure: Percentage of responders (ADHD-RS) as rated by parents and teachers
timeFrame: 5 & 10 weeks
measure: Percentage of responders (SEQ) as rated by parents and teachers
timeFrame: 5 & 10 weeks
measure: Social behavior problems subscale of the SEQ, as rated by parents and teachers
timeFrame: 10 weeks
measure: Anxiety subscale of the SEQ, as rated by parents and teachers
timeFrame: 10 weeks
measure: Physical and sleep complaints score as measured by the Physical Complaints Questionnaire (PCQ)
timeFrame: 5 & 10 weeks
measure: Erythrocyte glutathione (GSH) level
timeFrame: 10 weeks
measure: Urinary 8-OHdG level
timeFrame: 10 weeks
measure: Plasma cytokine levels
timeFrame: 10 weeks
measure: Plasma antibody levels
timeFrame: 10 weeks
measure: Gene expression
timeFrame: 10 weeks
measure: Serum neuropeptide Y
timeFrame: 10 weeks
measure: Serum zinc
timeFrame: 10 weeks
measure: Intestinal microbial composition
timeFrame: 10 weeks
measure: Intervention acceptability
timeFrame: 10 weeks
measure: Intervention acceptability
timeFrame: 10 weeks
measure: Intervention acceptability
timeFrame: 10 weeks
measure: Intervention acceptability
timeFrame: 10 weeks
measure: Urinary catecholamines
timeFrame: 10 weeks
measure: Plasma lipid-soluble vitamins
timeFrame: 10 weeks
measure: Long-term follow up
timeFrame: 6 months
measure: Long-term follow up
timeFrame: 6 months
measure: Long-term follow up
timeFrame: 6 months
Other outcomes:
Locations:
city: Borgerhout
country: Belgium
facility: Universitaire Kinder- en Jeugdpsychiatrie
city: Edegem
country: Belgium
facility: University Hospital Antwerp
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: Universiteit Antwerpen
name: Nina Hermans, PhD
role: STUDY_DIRECTOR
References:
citation: 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.