8 year effect modification by age of methylphenidate on the development of the dopaminergic system in the brai

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 149

Inclusion Criteria

ADHD patients:
- patients who participated in the ePOD-MPH RCT 8-9 years prior
(NL34509.000.10), OR
- Male outpatients diagnosed with ADHD (all subtypes) 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.

Control subjects:
- aged 19-20 years or 30-50 years
- male

Exclusion Criteria

All participants:
-Contra-indications to MRI (metal implants, pacemakers, claustrophobia, etc.).
-Contraindications to MPH challenge: cardiovascular diseases such as
hypertension, arrhythmia, hyperthyroidism, glaucoma, suicidality, psychosis,
Tourette disorder.

Newly included ADHD participants and control subjects:
-IQ < 80 National Adult Reading Test (NART; Nelson 1991, Dutch translation
Schmand et al. 1991)
-(History of) major neurological or medical illness (including epilepsy,
traumatic brain injury and chronic severe tics or Tourette syndrome).
-(History of) treatment with medications that influence the DA system (for ADHD
participants: not including psychostimulants for ADHD treatment ) such as:
neuroleptics, antipsychotics, D2/D3 agonists (pramipexole and ropinirole)
-(History of ) neuropsychiatric disorder other than ADHD (including ADHD for
controls) requiring pharmacological treatment
-(History of) dependency of alcohol or drugs that influence the DA such as:
MDMA, amphetamine, methamphetamine, cocaine, heroin and LSD
-First-degree relative with (history of) schizophrenia or major depression
-Prenatal use of MPH by mother of the patients.

Control subjects only:
-A score >4 on the ADHD Rating Scale (ADHD-RS)(Kooij et al. 2008).
-Prior treatment with MPH or other stimulants for ADHD

Study & Design

Study Type: Observational non 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.<br /><br>- Medication history (obtained from pharmacies of participants with ADHD that<br /><br>provided written consent).<br /><br>- Clinical outcome: change in ADHD symptom severity and global clinical<br /><br>impression.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Structural MRI: % change for several grey and white matter variables,<br /><br>including cortical thickness, and white matter microstructure (DTI).<br /><br>- Functional MRI: % change in task-related and resting-state BOLD signal.<br /><br>- Neuropsychological functioning: change in outcome of several well-validated<br /><br>neuropsychological (computer) tasks addressing attention, memory, simple<br /><br>reaction time and executive function.<br /><br>- Clinical outcome parameters: emotional dysregulation, anxiety and depressive<br /><br>symptomatology<br /><br>- Sleep log and actigraphy: % change from baseline.</p><br>