Effect of Pycnogenol® on ADHD
Phase 3
Completed
- Conditions
- ADHD
- Interventions
- Registration Number
- NCT02700685
- Lead Sponsor
- Nina Hermans
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pycnogenol 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 Placebo Placebo Placebo treatment (identical capsules containing excipients only) Methylphenidate 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
- Primary Outcome Measures
Name Time Method Summed ADHD score of the ADHD-Rating Scale as rated by teachers 10 weeks
- Secondary Outcome Measures
Name Time Method Scores on ADHD subscales of the ADHD-RS as rated by parents and teachers - hyperactivity, impulsivity and inattention 5 & 10 weeks Social behavior problems subscale of the SEQ, as rated by parents and teachers 10 weeks Anxiety subscale of the SEQ, as rated by parents and teachers 10 weeks Urinary 8-OHdG level 10 weeks Plasma antibody levels 10 weeks Gene expression 10 weeks Serum neuropeptide Y 10 weeks Serum zinc 10 weeks Summed ADHD score of the ADHD-Rating Scale as rated by teachers 5 weeks Summed ADHD score of the Social-Emotional Questionnaire (SEQ) as rated by parents and teachers 10 weeks Scores on ADHD subscales of the SEQ as rated by parents and teachers - hyperactivity, impulsivity and inattention 5 & 10 weeks Percentage of responders (ADHD-RS) as rated by parents and teachers 5 & 10 weeks Score reduction of at least 20% for parents and/or teachers
Summed ADHD score of the ADHD-Rating Scale as rated by parents 5 weeks, 10 weeks Percentage of responders (SEQ) as rated by parents and teachers 5 & 10 weeks Score reduction of at least 20% for parents and/or teachers
Physical and sleep complaints score as measured by the Physical Complaints Questionnaire (PCQ) 5 & 10 weeks Erythrocyte glutathione (GSH) level 10 weeks Plasma cytokine levels 10 weeks Intestinal microbial composition 10 weeks Intervention acceptability 10 weeks Treatment adherence
Long-term follow up 6 months Long-term follow up on physical/psychiatric complaints
Urinary catecholamines 10 weeks Plasma lipid-soluble vitamins 10 weeks
Trial Locations
- Locations (3)
University Hospital Antwerp
🇧🇪Edegem, Belgium
University Hospital Ghent
🇧🇪Ghent, Belgium
Universitaire Kinder- en Jeugdpsychiatrie
🇧🇪Borgerhout, Belgium