Table 1 Inclusion and exclusion criteria for patient selection
Inclusion criteria | Exclusion criteria |
|---|---|
1. Age 6–12 years (both inclusive) | 1. Diagnosis of autism spectrum disorder |
2. ADHD diagnosis a. based upon the diagnostic interview by the investigating physician b. based upon the ADHD-RS | 2. Pervasive developmental disorder, personality disorder, IQ <70, conduct disorder (CD), tics, schizophrenia, dyskinesia, personal or family history of psychotic disorder, bipolar illness, depression, or suicide attempt |
3. Responsible caregiver to provide information about the patient’s functional status | 3. Chronic medical disorder or acute inflammatory disease. Glaucoma, heart disease, high blood pressure, or peripheral vascular disease |
4. Patient and responsible caregiver have a sufficient level of knowledge of Dutch | 4. Use of MAO inhibitor 14 days before inclusion. Use of clonidine, guanethidine, seizure medicine, antidepressants, blood thinners, blood pressure, or diet medication 3 months before inclusion |
5. Written informed consent by the patient’s legally accepted representative | 5. Use of vitamin/mineral/herbal/omega-3 supplements or any medication for longer than 1 week, 3 months before inclusion |
6. Other contraindications for MPH or Pycnogenol®, as defined in the Summary of Product Characteristics and Investigator’s Brochure, respectively |