Pharmacokinetics, safety and efficacy of methylphenidate during pregnancy in women with Attention-Deficit (Hyperactivity) Disorder

Pharmacokinetics, safety and efficacy of methylphenidate during pregnancy in women with Attention-Deficit (Hyperactivity) Disorder - Methylphenidate during pregnancy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49916

Enrollment

Registered

2021-11-04

Start date

2022-08-06

Completion date

Unknown

Last updated

2024-11-18

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

Conditions

Attention deficit hyperactivity disorder

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant with a singleton Diagnosed with AD(H)D Age 18 years or older

Exclusion criteria

Exclusion criteria: Declared unfit by a psychiatrist Juridical status (care authorization) Prisoners

Design outcomes

Primary

Measure	Time frame
Serum levels methylphenidate (Immediate release: 2-3 hours after intake, extended release: 7 hours after intake)	—

Secondary

Measure	Time frame
Secondary outcomes: • Birth weight • Apgar score at 1 and 5 minutes • Score list withdrawal symptoms • Miscarriage • Major congenital malformations Explorative outcome: AD(H)D symptom severity; Weis functional impairment rating scale - self report (WFIRS-S)	—

Countries

Netherlands

Outcome results