Long-term effect modification by age of methylphenidate on the development of the dopaminergic system in the brain

Long-term effect modification by age of methylphenidate on the development of the dopaminergic system in the brain - ePOD-MPH 2.0

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50336

Enrollment

Registered

2015-11-12

Start date

2016-03-01

Completion date

Unknown

Last updated

2024-04-23

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

12 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Contra-indications to MRI (metal implants, pacemakers, claustrophobia, etc.). IQ

Design outcomes

Primary

Measure	Time frame
- phMRI: % change in ASL signal from baseline in response to acute oral MPH challenge at 3-4 year follow-up compared to baseline - Medication history	—

Secondary

Measure	Time frame
- fMRI: % change in task related BOLD signal at 3-4 year follow-up from baseline - Neuropsychological functioning: change in outcome of several well-validated neuropsychological (computer) tasks addressing emotional processing and impulsivity/behavioral inhibition compared to baseline measurements, and reward processing. - Sleep log and actigraphy: % change from baseline - Magnetic resonance spectroscopy (1H-MRS) for assessment of GABA and neurogenesis (1.28 ppm levels).	—

Measure

Time frame

- fMRI: % change in task related BOLD signal at 3-4 year follow-up from baseline - Neuropsychological functioning: change in outcome of several well-validated neuropsychological (computer) tasks addressing emotional processing and impulsivity/behavioral inhibition compared to baseline measurements, and reward processing. - Sleep log and actigraphy: % change from baseline - Magnetic resonance spectroscopy (1H-MRS) for assessment of GABA and neurogenesis (1.28 ppm levels).

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Countries

Netherlands

Outcome results