BridgeMD
Safety and pharmacokinetics of antipsychotics in children 2: Studying TDM in an RCT
EU CTIS ID: 2024-511568-96-00
What this study is testing
Our goal is to study the effectivity of therapeutic drug monitoring to prevent or mitigate side-effects of risperidone and aripiprazole use in children and adolescents. To this end we will study the differences in weight gain six months after start of treatment with risperidone or aripiprazole between a group of children receiving therapeutic drug monitoring based dosing advice and a group of children receiving risperidone or aripiprazole according to standard clinical care.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.