Attention Deficit Hyperactivity Disorder MedDRA version: 9.1 Level: LLT Classification code 10003735 Term: Attention deficit-hyperactivity disorder
Conditions
Interventions
Trade Name: Methylphenidate
Product Name: methylphenidate
Product Code: NA
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Centre for Human Drug Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent from parents having parental responsibility or from the legal guardian. In the case of a child aged 12 years the written informed consent of the child is needed in addition to that of parents having responsibility/legal guardian; • Aged 8-12 years; • Able to communicate with the investigator in Dutch; • Confirmed DSM IV diagnosis of ADHD (Based on examination by a psychiatrist or pediatrician); • Classifying as clinical ADHD on the AVL(“ADHD Vragenlijst”); • Currently receiving treatment with (immediate or sustained release) methylphenidate 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: • Use of drugs other than methylphenidate with known psychotropic effects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.to measure the effects of methylphenidate using the Neurocart test battery, to establish if these effects can be differentiated from placebo and to determine circadian variation in effect, 2.to describe the drug concentrations of methylphenidate in saliva, 3.to describe the PK/PD relationship using the obtained saliva samples, 4.to describe cardiovascular effects of methylphenidate (blood pressure and heart rate); 5.to evaluate clinical treatment effect during the trial, 6.to evaluate how children have experienced trial participation. ;Secondary Objective: ;Primary end point(s): - Results of Neurocognitive tasks: - Stroop color-word task - Adaptive tracking - Smooth eye pursuit - Saccadic Eye movements - Finger tapping - Body sway - Choice Reaction Task - Electro-encephalograms - Methylphenidate concentrations in saliva - Cardiovascular parameters (blood pressure and heart rate) - Evaluation of clinical treatment effect using the “ADHD Vragenlijst” - Results of a short questionnaire taken after completion of the Neurocognitive tasks. | — |
Countries
Netherlands
Outcome results
None listed