Safety and pharmacokinetics of antipsychotics in children 2: Studying TDM in an RCT
Phase 1
- Conditions
- Autism spectrum disorderTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 280
Inclusion Criteria
? Age 6 to 18 years ? Documented clinical diagnosis of autism spectrum disorder according to DSM IV or DSM V and comorbid behavioural problems ? To start treatment with risperidone or aripiprazole
Exclusion Criteria
? Diabetes type I or II ? Congenital or acquired syndrome associated with changes in appetite, body weight or lipid profile (e.g. Prader Willi) ? Known history of Long QT syndrome (LQTS), cardiovascular disorders (myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities), seizure disorder or oesophageal dysmotility ? Pregnancy ? Hypersensitivity to the active substance or to any of the excipients
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method