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

8 year effect modification by age of methylphenidate on the development of the dopaminergic system in the brain - ePOD-MPH 3.0

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49555

Enrollment

149

Registered

2021-03-19

Start date

2021-05-11

Completion date

Unknown

Last updated

2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

attention deficit hyperactivity disorder (ADHD)

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 4 on the ADHD Rating Scale (ADHD-RS)(Kooij et al. 2008). -Prior treatment with MPH or other stimulants for ADHD

Design outcomes

Primary

Measure	Time frame
- phMRI: % change in ASL signal from baseline in response to acute oral MPH challenge. - Medication history (obtained from pharmacies of participants with ADHD that provided written consent). - Clinical outcome: change in ADHD symptom severity and global clinical impression.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results