ong-term effect modification by age of methylphenidate on the development of the dopaminergic system in the brai
Completed
- Conditions
- attention deficit hyperactivity disorder (ADHD)attention disorder1004225810009841
- Registration Number
- NL-OMON50336
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 99
Inclusion Criteria
Patients: patients that participated in the ePOD-MPH RCT 3-4 years previously:
50 adolescent (10-12 years at time of RCT inclusion) and 49 adult (23-40 years
of age at time of RCT inclusion) male outpatients diagnosed with type ADHD, all
subtypes as defined in the DSM-IV. Patients are asked to stop with their ADHD
medication for at least one week before the assessment.
Exclusion Criteria
Contra-indications to MRI (metal implants, pacemakers, claustrophobia, etc.).
IQ < 80.
Prenatal use of methylphenidate by mother of the patients.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- phMRI: % change in ASL signal from baseline in response to acute oral MPH<br /><br>challenge at 3-4 year follow-up compared to baseline<br /><br>- Medication history</p><br>
- Secondary Outcome Measures
Name Time Method <p>- fMRI: % change in task related BOLD signal at 3-4 year follow-up from baseline<br /><br>- Neuropsychological functioning: change in outcome of several well-validated<br /><br>neuropsychological (computer) tasks addressing emotional processing and<br /><br>impulsivity/behavioral inhibition compared to baseline measurements, and reward<br /><br>processing.<br /><br>- Sleep log and actigraphy: % change from baseline<br /><br>- Magnetic resonance spectroscopy (1H-MRS) for assessment of GABA and<br /><br>neurogenesis (1.28 ppm levels).</p><br>