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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | Placebo treatment (identical capsules containing excipients only) |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pycnogenol | Dietary Supplement | Dietary supplement, standardised extract of French maritime Pine bark. This group receives a nutritional supplement for a period of 10 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summed ADHD score of the ADHD-Rating Scale as rated by teachers | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nina Hermans, PhD | Universiteit Antwerpen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaire Kinder- en Jeugdpsychiatrie | Borgerhout | Belgium | ||||
| University Hospital Antwerp |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28351412 | Derived | 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. |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C024070 | pycnogenols |
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Methylphenidate | Drug | Standard pharmaceutical treatment for ADHD, slow release. |
|
| Placebo | Other | Placebo treatment (identical capsules containing excipients only) |
|
| 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 |
| 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 |
| Percentage of responders (SEQ) as rated by parents and teachers | Score reduction of at least 20% for parents and/or teachers | 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 |
| Physical and sleep complaints score as measured by the Physical Complaints Questionnaire (PCQ) | 5 & 10 weeks |
| Erythrocyte glutathione (GSH) level | 10 weeks |
| Urinary 8-OHdG level | 10 weeks |
| Plasma cytokine levels | 10 weeks |
| Plasma antibody levels | 10 weeks |
| Gene expression | 10 weeks |
| Serum neuropeptide Y | 10 weeks |
| Serum zinc | 10 weeks |
| Intestinal microbial composition | 10 weeks |
| Intervention acceptability | Percentage of participants with side effects, treatment adherence and proportion of drop-outs | 10 weeks |
| Intervention acceptability | Percentage of participants with side effects | 10 weeks |
| Intervention acceptability | Proportion of drop-outs | 10 weeks |
| Intervention acceptability | Treatment adherence | 10 weeks |
| Urinary catecholamines | 10 weeks |
| Plasma lipid-soluble vitamins | 10 weeks |
| Long-term follow up | Long-term follow up on eventual treatment choice (medication, no intervention, nutritional supplement) | 6 months |
| Long-term follow up | Long-term follow up on behaviour | 6 months |
| Long-term follow up | Long-term follow up on physical/psychiatric complaints | 6 months |
| Edegem |
| 2650 |
| Belgium |
| University Hospital Ghent | Ghent | 9000 | Belgium |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |