Attention Deficit - Hyperactivity Disorder (AD/HD) MedDRA version: 8.1 Level: LLT Classification code 10003735 Term: Attention deficit-hyperactivity disorder
Conditions
Interventions
Trade Name: Ritalin
Product Name: Ritalin
Pharmaceutical Form: Tablet
Sponsors
Mentis Cura ehf.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Healthy subjects: – Male – Between 6-8 years of age – On the parent-completed SDQ, scores on the four proplem subscales (Hyperactivity, Emotional Problems, Conduct Problems, Peer Problems) should not exceed 1.0 standard deviation above the age appropriate mean. On the AD/HD Rating scale-IV, Inattention and Hyperactivity subscores should not exceed one standard deviation above the mean. The means and standard deviations mentioned here refer to Icelandic norms. AD/HD subjects: – Male – Between 6-8 years of age – Recently diagnosed with AD/HD according to DSM-IV – Other possibilities have been exhausted and treatment using methylphenidate (Ritalin®) is the only viable option left Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: – Individual has Tourette syndrome – Individual suffers from psychosis – Individual suffers from mental retardation – Individual allergic to the investigational material – Individual is receiving treatment for other diseases affecting the central nervous system – Hypersensitivity to methylphenidate or any other component in the Ritalin® formulation – Participation in another investigational study at the same time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main goal is to perform this pilot study where we try to duplicate some of the results of other recent experiments and show we can do at least as well, preferably better. Furthermore, using a CNS drug enhancer, we intend to measure the effect of a common AD/HD treatment on the EEG of AD/HD patients, thus hoping to get a high degree of separation of individuals belonging to various subgroups of AD/HD. The main objective of using a CNS drug enhancer is to determine if there are any features of the EEG that can predict success of treatment for a given individual who has been diagnosed with AD/HD.;Secondary Objective: ;Primary end point(s): The endpoint of the study is to have 120 EEG measurements from two groups of 40 boys. 80 EEGs from a group of 40 boys who have recently been diagnosed with ADHD and are between 6 and 8 years of age and 40 EEGs from another group of 40 healthy age matched boys. The clinical group is measured before and after Ritalin® administration. | — |
Countries
Iceland
Outcome results
None listed