What we do
About our project
In SPACe 2 STAR, we aim to reach further, we will test whether application of therapeutic drug monitoring (TDM) in clinical practice is able to reduce the number/severity of metabolic side-effects, while retaining clinical effectiveness in children by means of a randomized controlled trial.
In this study, research is being conducted on the medications risperidone ("Risperdal") and aripiprazole ("Abilify"). These medications often work well but also have side effects. A common side effect is weight gain. It is known that there is a relationship between the amount of the medication in the blood and the side effects. We aim to further investigate this relationship in this study. We hope that in the future, this research will help us better dose these medications in children and thus reduce the risk of side effects. Children (between 6 and18 years) diagnosed with an autism spectrum disorder and comorbid behavioral problems who start with risperidone or aripiprazole treatment are eligible for inclusion.
We will study the ability of TDM to reduce risperidone and aripiprazole induced side effects in a randomized control trial. Patients will be randomized to receive therapeutic drug monitoring or to care as usual (CAU), which does not include therapeutic drug monitoring. In the TDM group, drug levels will be measured by means of finger prick at 4 and 10 weeks after start of antipsychotic treatment. Based on these drug levels, dosing advice will be given to the treating physicians. In the CAU arm drug levels will be determined, but no dosing recommendations are given. Metabolic parameters (BMI, cholesterol, triglycerides) as well irritability/aggression symptom severity will be measured in both groups at baseline (before start of antipsychotic treatment), and 4, 10, 24 and 52 weeks later. With a follow-up time of one year, we will be able to determine the value of TDM over a longer time period.
In this study, research is being conducted on the medications risperidone ("Risperdal") and aripiprazole ("Abilify"). These medications often work well but also have side effects. A common side effect is weight gain. It is known that there is a relationship between the amount of the medication in the blood and the side effects. We aim to further investigate this relationship in this study. We hope that in the future, this research will help us better dose these medications in children and thus reduce the risk of side effects. Children (between 6 and18 years) diagnosed with an autism spectrum disorder and comorbid behavioral problems who start with risperidone or aripiprazole treatment are eligible for inclusion.
We will study the ability of TDM to reduce risperidone and aripiprazole induced side effects in a randomized control trial. Patients will be randomized to receive therapeutic drug monitoring or to care as usual (CAU), which does not include therapeutic drug monitoring. In the TDM group, drug levels will be measured by means of finger prick at 4 and 10 weeks after start of antipsychotic treatment. Based on these drug levels, dosing advice will be given to the treating physicians. In the CAU arm drug levels will be determined, but no dosing recommendations are given. Metabolic parameters (BMI, cholesterol, triglycerides) as well irritability/aggression symptom severity will be measured in both groups at baseline (before start of antipsychotic treatment), and 4, 10, 24 and 52 weeks later. With a follow-up time of one year, we will be able to determine the value of TDM over a longer time period.
Collaborations
Internal collaborations
- Department of Child- and adolescent psychiatry/psychology
- Hospital Pharmacy department
- Clinical chemistry department
- Department of Endocrinology
External collaborations
- GGz Breburg
- GGZ Delfland
- Yulius GGZ
- LUMC Curium
- Accare
- Karakter
- ’s Heeren Loo
- Mondriaan
- Universiteitskliniek Würzburg
- Universiteitskliniek Tübingen
- Mariaberg Fachkrankenhaus
Publications
Hermans, R. A., Ringeling, L. T., Liang, K., Kloosterboer, S. M., de Winter, B. C. M., Hillegers, M. H. J., Koch, B. C. P., & Dierckx, B. (2022). The effect of therapeutic drug monitoring of risperidone and aripiprazole on weight gain in children and adolescents: the SPACe 2: STAR (trial) protocol of an international multicentre randomised controlled trial. BMC psychiatry, 22(1), 814. https://doi.org/10.1186/s12888-022-04445-6
Bais, Y., Hermans, R. A., Schuiling-Veninga, C. C. M., Bos, H. J., Kloosterboer, S. M., de Winter, B. C. M., Simoons, M., Dieleman, G. C., Hillegers, M. H. J., Koch, B. C. P., & Dierckx, B. (2023). Comparison of antipsychotic drug use among Dutch Youth before and after implementation of the Youth Act (2010-2019). European child & adolescent psychiatry, 32(8), 1427–1434. https://doi.org/10.1007/s00787-022-01949-0
Hermans, R. A., Sassen, S. D. T., Kloosterboer, S. M., Reichart, C. G., Kouijzer, M. E. J., de Kroon, M. M. J., Bastiaansen, D., van Altena, D., van Schaik, R. H. N., Nasserinejad, K., Hillegers, M. H. J., Koch, B. C. P., Dierckx, B., & de Winter, B. C. M. (2023). Towards precision dosing of aripiprazole in children and adolescents with autism spectrum disorder: Linking blood levels to weight gain and effectiveness. British journal of clinical pharmacology, 89(10), 3026–3036. https://doi.org/10.1111/bcp.15800
Bais, Y., Hermans, R. A., Schuiling-Veninga, C. C. M., Bos, H. J., Kloosterboer, S. M., de Winter, B. C. M., Simoons, M., Dieleman, G. C., Hillegers, M. H. J., Koch, B. C. P., & Dierckx, B. (2023). Comparison of antipsychotic drug use among Dutch Youth before and after implementation of the Youth Act (2010-2019). European child & adolescent psychiatry, 32(8), 1427–1434. https://doi.org/10.1007/s00787-022-01949-0
Hermans, R. A., Sassen, S. D. T., Kloosterboer, S. M., Reichart, C. G., Kouijzer, M. E. J., de Kroon, M. M. J., Bastiaansen, D., van Altena, D., van Schaik, R. H. N., Nasserinejad, K., Hillegers, M. H. J., Koch, B. C. P., Dierckx, B., & de Winter, B. C. M. (2023). Towards precision dosing of aripiprazole in children and adolescents with autism spectrum disorder: Linking blood levels to weight gain and effectiveness. British journal of clinical pharmacology, 89(10), 3026–3036. https://doi.org/10.1111/bcp.15800
