Pharmacokinetics, safety and efficacy of methylphenidate during pregnancy in women with Attention-Deficit (Hyperactivity) Disorder
- Conditions
- Attention deficit hyperactivity disorder1002690610009841
- Registration Number
- NL-OMON49916
- Lead Sponsor
- Isala Klinieken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
Pregnant with a singleton
Diagnosed with AD(H)D
Age 18 years or older
Exclusion Criteria
Declared unfit by a psychiatrist
Juridical status (care authorization)
Prisoners
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Serum levels methylphenidate<br /><br>(Immediate release: 2-3 hours after intake,<br /><br>extended release: 7 hours after intake)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes:<br /><br />• Birth weight<br />• Apgar score at 1 and 5 minutes<br />• Score list withdrawal symptoms<br />• Miscarriage<br />• Major congenital malformations<br /><br />Explorative outcome:<br /><br />AD(H)D symptom severity; Weis functional impairment rating scale - self report<br />(WFIRS-S)</p>