Effects of methylphenidate on the developing brain.
- Conditions
- Effect of methylphenidate treatment on the outgrowth of the dopaminergic system in children and young adults with attention-deficit hyperactivity disorder.Effect van de behandeling met methylfenidaat op de uitgroei van het dopamine systeem in kinderen en jong volwassenen met ADHD
- Registration Number
- NL-OMON20266
- Lead Sponsor
- Academic Medical Center Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Male outpatients (ages 10-12 and 23-40) newly diagnosed with ADHD as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV, American Psychiatric Association 1994) and as determined by a structured interview: Diagnostic Interview Schedule for Children fourth edition (DISC-IV; Ferdinand et al., 1998) in parents or Diagnostic Interview voor ADHD bij volwassenen (DIVA; Kooij andFrancken, 2010) in adults.
1. Co-morbid Axis I psychiatric disorders requiring treatment with medication at study entry;
2. Major medical illness, such as a history of epilepsy and traumatic brain injury;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. phMRI: % change in ASL signal from baseline in response to acute oral MPH challenge before and after 16 weeks of MPH treatment;<br /><br>2. DTI: % change in FA and MD values from baseline after 16 weeks of MPH treatment;<br /><br>3. Resting state fMRI (rs-fMRI): % change in functional connectivity (FC) within specific (DA) neuronal networks;<br /><br>4. % change of above mentioned outcome parameters during treatment vs. baseline and post-treatment.
- Secondary Outcome Measures
Name Time Method 1. fMRI: % change in task related BOLD signal from baseline;<br /><br>2. Neuropsychological functioning: change in outcome of several well-validated neuropsychological (computer) tasks addressing emotional processing and impulsivity/behavioral inhibition compared to baseline measurements;<br /><br>3. Sleep log and actigraphy: % change from baseline.