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Saliva pharmacokinetics of methylphenidate (MPH) following ingestion of immediate and sustained release formulations in children with attention- deficit hyperactivity disorder (ADHD)

Saliva pharmacokinetics of methylphenidate (MPH) following ingestion of immediate and sustained release formulations in children with attention- deficit hyperactivity disorder (ADHD) - SALMIAC (SALiva Methylphenidate In Adhd Children)

Status
Unknown
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37735
Enrollment
10
Registered
2013-02-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

ADHD attention deficit hyperactivity disorder

Interventions

None listed

Sponsors

Maasstadziekenhuis
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: ADHD 6-18 y

Exclusion criteria

Exclusion criteria: no ADHD

Design outcomes

Primary

MeasureTime frame
The main study endpoint is the area under the MPH saliva concentration versus time curve (AUC) following ingestion of a formulation with immediate and sustained release MPH.

Secondary

MeasureTime frame
a. The time profiles of the hormones cortisol, testosterone and DHEA in saliva following the two different formulations. b. The genetic difference in esterase activity between individuals c. The relationship between saliva MPH concentration and clinical effect and hormone concentration d. The correlation between MPH concentrations in saliva and plasma

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)